Actonel is a brand-name prescription drug. It’s FDA-approved for the following bone conditions:

  • Osteoporosis in postmenopausal women. For this use, Actonel is prescribed for women with osteoporosis who’ve gone through menopause. The drug can be used to prevent or treat this condition.
  • Osteoporosis in men. Actonel is used to treat osteoporosis in adult males.
  • Glucocorticoid-induced osteoporosis. For this use, Actonel is prescribed for adults whose osteoporosis was caused by using certain corticosteroids. Actonel can be used to prevent or treat this condition.
  • Paget’s disease. Actonel is used to treat Paget’s disease in adults.

Drug details

Actonel contains the active drug risedronate. It belongs to a group of drugs called bisphosphonates. Bisphosphonates work by slowing down your body’s natural breakdown of bone. And these drugs help to increase the thickness of your bone tissue.

Actonel comes as tablets that are taken by mouth. It’s available in the following strengths: 5 milligrams (mg), 30 mg, 35 mg, 75 mg, and 150 mg. How often you’ll take Actonel varies depending on the strength of the drug your doctor prescribes and the condition you’re treating.

Actonel may be used as part of a combination therapy. This means that in some cases, you may need to take it with other medications.

Length of use

It’s important to note that how long Actonel should be used hasn’t been determined. But for people with osteoporosis who have a low risk of bone fracture, it’s recommended that Actonel treatment last only about 3 to 5 years.

Effectiveness

For information on the effectiveness of Actonel, see the “Actonel uses” section below.

Actonel contains the active drug risedronate, which is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

Actonel can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Actonel. These lists don’t include all possible side effects.

For more information on the possible side effects of Actonel, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Actonel, you can do so through MedWatch.

Mild side effects

Mild side effects of Actonel can include:*

  • pain, such as back pain
  • flu-like symptoms, including fever, chills, and muscle aches
  • headache
  • increased blood pressure
  • digestive problems, including indigestion, constipation, and diarrhea
  • dizziness
  • trouble sleeping
  • skin rash

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Actonel. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Actonel’s Medication Guide.
† This mild side effect is described further in the “Side effect details” section below.

Serious side effects

Serious side effects from Actonel aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Problems with your esophagus (the muscular tube that connects your mouth and stomach). Symptoms can include:
    • irritation and swelling of the esophagus
    • ulcers (holes or sores) in the lining of the esophagus
    • bleeding in the esophagus
  • Hypocalcemia (low calcium level). Symptoms can include:
    • muscle spasms
    • spasms or twitching of the muscles
    • tingling or numbness in your fingers, toes, or mouth
  • Urinary tract infection (UTI). Symptoms can include:
    • frequent urination
    • burning sensation while urinating
    • dark-, red-, or brown-colored urine
  • Allergic reaction.*
  • Pain in your bones, joints, or muscles.*
  • Jaw bone problems, such as osteonecrosis.*
  • Femur (thigh bone) fractures.*
  • Eye side effects, such as cataracts.*

* This serious side effect is described further in the “Side effect details” section below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Actonel. In clinical studies of women with osteoporosis who’d gone through menopause, allergic reaction occurred in:

  • 3.8% of women taking Actonel 5 mg
  • 5.9% of women taking a placebo (treatment with no active drug)

It’s not known how many other people using Actonel during the studies had an allergic reaction to this drug.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Actonel. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Side effects from weekly or monthly use of Actonel

Side effects of Actonel can occur with any dosing schedule of the drug. One study looked at women with osteoporosis who’d gone through menopause. The researchers found there weren’t significant differences in how well the drug worked or how safe it was when given once daily compared with once weekly.

However, taking higher doses of Actonel may increase your risk of side effects, depending on how you take Actonel. For example, another study looked at women with osteoporosis who’d gone through menopause. Researchers compared once-daily Actonel treatment with once-monthly Actonel treatment.

The researchers found that women who took Actonel 150 mg once a month had higher rates of certain side effects compared with women who took Actonel 5 mg once a day. These side effects included diarrhea, for example. In addition, women who took Actonel 150 mg once a month were more likely to stop taking the drug due to diarrhea or belly pain compared with women who took Actonel 5 mg daily.

If you have questions about side effects of Actonel related to your specific dosage, talk with your doctor.

Bone, muscle, and joint pain

Actonel may cause pain in your bones, muscles, and joints. In clinical studies of people with osteoporosis, the following side effects were seen:

  • Muscle pain, which occurred in 6.7% of people taking Actonel. In comparison, muscle pain occurred in 6.2% of people taking a placebo (treatment with no active drug).
  • Joint pain, which occurred in 23.7% of people taking Actonel. In comparison, joint pain occurred in 22.1% of people taking a placebo.
  • Bone pain, which occurred in 5.3% of people taking Actonel. In comparison, bone pain occurred in 4.8% of people taking a placebo.

In clinical studies of people with Paget’s disease, joint pain occurred in:

  • 32.8% of people taking Actonel
  • 29.5% of people taking Didronel*

* Didronel is a drug that was also approved to treat Paget’s disease. But Didronel has been discontinued and it’s no longer available on the market.

Jaw bone problems

It’s possible that Actonel may cause problems with your jaw bone. Specifically, some people taking Actonel may develop osteonecrosis in their jaw. With osteonecrosis, cells in your bone tissue die.

Having osteonecrosis in your jaw may cause symptoms such as:

  • pain in your jaw area
  • exposed jaw bone (being able to see part of your jawbone poking through your gums)
  • tingling or numbness in your mouth

Jaw bone problems from Actonel can be very serious, but they aren’t common. Some studies have shown that osteonecrosis in the jaw happens in just under 1 person for every 100,000 people who take Actonel for 1 year.

If you have pain or other problems with your jaw bone during Actonel treatment, talk with your doctor. They may be able to recommend ways to reduce your symptoms. If you develop jaw bone problems such as osteonecrosis, they’ll likely recommended that you see an oral surgeon. Your doctor may also recommend that you stop taking Actonel and try a different medication for your condition.

Risk factors for jaw bone problems with Actonel

Some factors can affect your risk of having jaw bone problems while taking Actonel. These include:

  • having an invasive dental procedure, such as a tooth extraction
  • having cancer
  • receiving certain other medications, such as corticosteroids
  • practicing poor oral hygiene
  • having certain other conditions, such as:
    • other preexisting dental conditions
    • blood disorders, such as anemia
  • wearing dentures that don’t fit well

If you need to have an invasive dental procedure while you’re taking Actonel, your doctor or surgeon may recommend that you stop taking Actonel. Be sure your doctors and dentists are aware you’re taking Actonel before you have any dental procedures done.

In addition, your risk of having jaw bone problems may increase the longer you take a bisphosphonate medication, such as Actonel. Having good oral hygiene habits while you’re taking Actonel may help reduce your risk for this side effect.

Femur fractures

Some people taking Actonel may have fractures in their femur (thigh) bone. Even though Actonel is used to help decrease bone loss and strengthen bones, some people taking the drug have had bone fractures.

For example, in clinical studies, femur fractures occurred in:

  • 9.3% of people taking Actonel
  • 12.3% of people taking a placebo (treatment with no active drug)

Keep in mind that while people taking Actonel have had bone fractures, it’s not known for sure if Actonel caused their fractures.

Some femur fractures happen without any trauma to the bone. They can affect one or both legs. Many people report a dull, aching pain in their thigh that starts weeks or months before the fracture actually happens.

If you’re concerned about having bone fractures while using Actonel, talk with your doctor. They can discuss with you the risks and benefits of using this drug. And if you begin to have pain in your thigh or groin, talk with your doctor. They’ll likely want to see if your leg has an incomplete fracture. (With an incomplete fracture, your bone cracks but doesn’t break all the way through.)

Eye side effects

Some people may have eye problems while taking Actonel. For example, in clinical studies of women with osteoporosis who had gone through menopause, cataracts (cloudiness in the lens of the eye) developed in:

  • 6.5% of women taking Actonel
  • 5.7% of women taking a placebo (treatment with no active drug)

However, cataracts weren’t reported as a side effect in Actonel studies in people with Paget’s disease.

Also in these studies, less than 1% of people had inflammation or swelling in their eye.

Symptoms of cataracts may include blurry or cloudy vision. With this condition, it may also be more difficult to see well in dim light. Symptoms of eye inflammation can include swelling and redness in your eye area.

If you have any changes in vision or other eye problems while taking Actonel, talk with your doctor. They may recommend ways to help reduce your symptoms.

Diarrhea

It’s possible to have diarrhea while you’re taking Actonel. In fact, during clinical studies of women with osteoporosis who’d gone through menopause, diarrhea occurred in:

  • 10.8% of people taking Actonel
  • 10% of people taking a placebo (treatment with no active drug)

In clinical studies of people with Paget’s disease, diarrhea occurred in:

  • 19.7% of people taking Actonel
  • 14.8 % of people taking Didronel*

If you have diarrhea during Actonel treatment, talk with your doctor. They can recommend ways to help relieve this side effect.

* Didronel is a drug that was also approved to treat Paget’s disease. But Didronel has been discontinued and it’s no longer available on the market.

The Actonel dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Actonel to treat
  • your age
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Actonel comes as tablets that are taken by mouth. It’s available in the following strengths: 5 milligrams (mg), 30 mg, 35 mg, 75 mg, and 150 mg.

Dosage for preventing osteoporosis after menopause

The typical dosage of Actonel to prevent osteoporosis in women who’ve gone through menopause is one of the following:

  • one 5-mg tablet taken once daily
  • one 35-mg tablet taken once weekly
  • one 75-mg tablet taken two days in a row, once a month
  • one 150-mg tablet taken once a month

Dosage for treating osteoporosis after menopause

The typical dosage of Actonel to treat osteoporosis in women who’ve gone through menopause is one of the following:

  • one 5-mg tablet taken once daily
  • one 35-mg tablet taken once weekly
  • one 75-mg tablet taken two days in a row, once a month
  • one 150-mg tablet taken once a month

Dosage for treating osteoporosis in men

The typical dosage of Actonel to treat osteoporosis in men is one 35-mg tablet taken once weekly.

Dosage for preventing osteoporosis due to glucocorticoid use

The typical dosage of Actonel to prevent osteoporosis that’s caused by using glucocorticoids* is one 5-mg tablet taken once daily.

* Glucocorticoids are a type of corticosteroid. The use of corticosteroids may lead to bone loss and osteoporosis.

Dosage for treating osteoporosis due to glucocorticoid use

The typical dosage of Actonel to treat osteoporosis that’s caused by using glucocorticoids* is one 5-mg tablet taken once daily.

* Glucocorticoids are a type of corticosteroid. The use of corticosteroids may lead to bone loss and osteoporosis.

Dosage for Paget’s disease

The typical dosage of Actonel to treat Paget’s disease is one 30-mg tablet taken once daily. For this condition, treatment courses last for 2 months.

Dosage questions

Below we provide answers to some common questions related to dosage of Actonel.

What if I miss a dose?

If you miss a dose of Actonel, call your doctor’s office to find out when to take your next dose. Your doctor or their medical staff can help advise when you should take your next dose of the drug.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

For most conditions, Actonel is meant to be used as a long-term treatment. If you and your doctor determine that Actonel is safe and effective for you, you’ll likely take it long term.

However, if you’re taking Actonel for Paget’s disease, your treatment will likely be short term. People with this condition typically take Actonel for just 2 months.

You may wonder how Actonel compares with other medications that are prescribed for similar uses. Here we look at how Actonel and Fosamax are alike and different.

Ingredients

Actonel contains the active drug risedronate, while Fosamax contains the active drug alendronate. These medications both belong to a group of drugs called bisphosphonates.

Uses

Both Actonel and Fosamax are approved for the following uses:

In addition, Actonel is used to prevent osteoporosis that’s caused by using certain corticosteroids in adults.

Drug forms and administration

Actonel comes as tablets that are taken by mouth. How often you’ll take Actonel varies depending on the strength of the drug your doctor prescribes and the condition you’re treating.

Fosamax comes as tablets that are taken by mouth. How often you’ll take Fosamax varies depending on the condition you’re treating.

Side effects and risks

Actonel and Fosamax both contain drugs that are bisphosphonates. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Actonel, with Fosamax, or with both drugs (when taken individually).

  • Can occur with Actonel:
    • flu-like symptoms, including fever, chills, and muscle aches
    • trouble sleeping
    • skin rash
  • Can occur with Fosamax:
    • swollen, enlarged belly
    • changes in taste
  • Can occur with both Actonel and Fosamax:
    • pain, such as back pain
    • headache
    • digestive problems, including indigestion, constipation, and diarrhea
    • dizziness

Serious side effects

These lists contain examples of serious side effects that can occur with Actonel, with Fosamax, or with both drugs (when taken individually).

Effectiveness

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Actonel and Fosamax to be effective for the following uses:

  • preventing or treating osteoporosis in women who’ve gone through menopause
  • treating osteoporosis in men
  • treating osteoporosis that’s caused by using certain corticosteroids in adults
  • treating Paget’s disease in adults

Costs

Actonel costs more than Fosamax costs. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Actonel and Fosamax are both brand-name drugs. There are currently generic forms available of both drugs. (A generic medication is an exact copy of the active drug found in a brand-name medication.) Brand-name medications usually cost more than generics.

The generic form of Fosamax, called alendronate, is available as both tablets and a liquid that you take by mouth.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Actonel, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for preventing osteoporosis

Examples of other drugs that may be used to prevent osteoporosis include:

  • alendronate (Fosamax)
  • ibandronate (Boniva)
  • raloxifene (Evista)
  • zoledronic acid (Reclast)

Alternatives for treating osteoporosis

Examples of other drugs that may be used to treat osteoporosis include:

Alternatives for Paget’s disease

Examples of other drugs that may be used to treat Paget’s disease include:

  • alendronate (Fosamax)
  • ibandronate (Boniva)
  • pamidronate (Aredia)
  • zoledronic acid (Reclast)

Here are answers to some frequently asked questions about Actonel.

How long does Actonel stay in your system?

Typically, Actonel stays in your body for 1 to 2 months after you’ve stopped treatment. During this period of time, levels of the drug will slowly decrease until Actonel has been largely cleared from your system.

Keep in mind that part of the way Actonel works is by becoming part of newly formed bone. That means it can remain in your bone for years. However, it’s not fully understood how long the drug will have any effect on your bone.

Can Actonel cause cancer?

It’s not known whether Actonel increases the risk of cancer. Some recent studies have looked at the relationship between Actonel and cancer.

In one review of clinical information, researchers found that the risk of esophageal cancer was not increased in people who took bisphosphonates. (Bisphosphonates are a group of drugs that includes Actonel.)

In a second review, the risk of esophageal cancer was nearly doubled in people who had:

  • filled a bisphosphonate drug prescription at least 10 times, compared with people who filled a bisphosphonate drug prescription between 1 and 9 times, or
  • taken a bisphosphonate drug for at least 3 years, compared with people who hadn’t taken a bisphosphonate drug

It’s important to note that side effects, including cancer risk, can vary from person to person. If you’re concerned about developing cancer with Actonel treatment, talk with your doctor. They can discuss with you the risks and benefits of using this drug.

Does using Actonel lead to hair loss?

No, hair loss hasn’t been reported as a side effect of Actonel. But some people who’ve taken bisphosphonates other than Actonel have reported hair loss. (Bisphosphonates are a group of drugs that includes Actonel.)

For instance, some people taking the bisphosphonate drug called Fosamax reported hair loss. However, this side effect wasn’t reported during clinical trials of the drug. Instead, people reported hair loss after the drug was released onto the market. So it’s not known for sure if their hair loss was due to Fosamax or another cause.

If you’re concerned about hair loss while you’re taking Actonel, talk with your doctor.

Will I have to taper off Actonel when my doctor has me stop using it?

No, with Actonel, you typically don’t have to taper off of the drug when stopping treatment. (To taper off of a drug, your dosage is slowly lowered over a period of time.) But if you’d like to stop using Actonel, talk with your doctor first. They’ll determine the best way to have you stop taking this drug.

Note: How long Actonel should be used hasn’t been determined. But for people with osteoporosis who have a low risk of bone fracture, it’s recommended that Actonel treatment last only about 3 to 5 years.

Is Actonel a steroid?

No, Actonel isn’t a steroid. Steroids are drugs that help stop inflammation in your body.

Instead, Actonel belongs to a group of medications called bisphosphonates. These drugs help to slow down bone loss and increase thickness of your bones.

Why do I have to take Actonel with water and not a different drink?

It’s recommended that you take Actonel with water because this drug can cause irritation in your esophagus. (Your esophagus is the muscular tube that connects your mouth and stomach.) Taking Actonel with any liquid other than water can increase the risk of irritation in your esophagus.

If you have questions about how to take Actonel, talk with your doctor or pharmacist.

What’s the difference between Actonel and Actonel DR?

Both Actonel and Actonel DR contain the same active drug: risedronate. However, Actonel DR isn’t available for use in the United States. It’s only approved for use in Canada.

Actonel comes as immediate-release (IR) tablets, while Actonel DR comes as delayed-release (DR) tablets. IR tablets release their active drug all at once into your body. This is unlike DR tablets, which release their active drug over a longer period of time.

Unlike Actonel, Actonel DR is only approved to treat osteoporosis in women who’ve gone through menopause. It’s not approved for the other uses that Actonel is approved for.

This article focuses on Actonel. If you’d like to know more about Actonel DR, talk with your doctor or pharmacist.

It’s not known if alcohol interacts with Actonel. However, both Actonel and alcohol can irritate your esophagus (the muscular tube that connects your mouth and stomach). Because of this, it’s best to avoid drinking alcohol while you’re taking Actonel.

If you have questions about consuming alcohol while taking Actonel, talk with your doctor.

Like Fosamax (discussed above), Prolia has uses similar to those of Actonel. Here’s a comparison of how Actonel and Prolia are alike and different.

Ingredients

Actonel contains the active drug risedronate, while Prolia contains the active drug denosumab. These drugs belong to different classes of medications. (Medication classes describe groups of drugs that work in similar ways.)

Uses

Here’s a list of conditions that Actonel and Prolia can be used for.

  • Both Actonel and Prolia are approved to:
    • treat osteoporosis in adults that’s caused by using certain corticosteroids
  • Prolia is also approved to:
    • treat osteoporosis in women who’ve gone through menopause and have a high risk of fracture
    • treat bone loss in women taking certain therapy for breast cancer

Drug forms and administration

Actonel comes as tablets that are taken by mouth. How often you’ll take Actonel varies depending on the strength of the drug your doctor prescribes and the condition you’re treating.

Prolia comes as a liquid inside single-dose prefilled syringes. It’s given by healthcare providers as a subcutaneous injection (an injection under the skin). Injections of Prolia are typically given once every 6 months.

Side effects and risks

Actonel and Prolia both contain drugs to help slow bone loss. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Actonel, with Prolia, or with both drugs (when taken individually).

  • Can occur with Actonel:
    • flu-like symptoms, including fever, chills, and muscle aches
  • Can occur with Prolia:
    • upper respiratory tract infection, such as the common cold
    • sore throat
  • Can occur with both Actonel and Prolia:
    • pain, such as back pain
    • headache
    • digestive problems, including indigestion, constipation, and diarrhea
    • dizziness
    • trouble sleeping
    • skin rash

Serious side effects

These lists contain examples of serious side effects that can occur with Actonel, with Prolia, or with both drugs (when taken individually).

Effectiveness

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Actonel and Prolia to be effective in treating the following conditions:

  • osteoporosis in men
  • osteoporosis that’s caused by using certain corticosteroids in adults

Costs

Actonel is more expensive than Prolia is. The actual price you’ll pay for either drug depends on your insurance plan and your location. It also depends on whether you receive the drug from a pharmacy or doctor’s office.

Actonel and Prolia are both brand-name drugs. There is a generic form of Actonel available, but Prolia is only available as brand-name drug. (Generic medications are exact copies of the active drug found in brand-name medications.) Brand-name medications usually cost more than generics.

The Food and Drug Administration (FDA) approves prescription drugs such as Actonel to treat certain conditions. Below, we describe Actonel’s approved uses.

Actonel for osteoporosis

Actonel is approved to prevent or treat osteoporosis in certain situations, which are described below. With osteoporosis, your bones become thin and weak. And bone fractures can also occur more easily with this condition.

Many people don’t have symptoms from osteoporosis. But some possible symptoms of osteoporosis can include:

Actonel for preventing osteoporosis after menopause

Actonel is approved to prevent osteoporosis in women who’ve gone through menopause.

Sometimes, before a person develops osteoporosis, they have osteopenia. With osteopenia, your bones aren’t as strong as usual. But they’re not as weak and thin as they would be if you had osteoporosis. In some cases, if you have osteopenia, your doctor may recommend Actonel to help prevent osteoporosis from developing.

Effectiveness for preventing osteoporosis after menopause

In clinical studies involving women who’d gone through menopause, bone mineral density (BMD) was measured. BMD is a measurement that shows how strong your bones are. It’s often used to evaluate people with osteoporosis.

In a 1-year study, BMD was measured in the lower spine, femoral (thigh) bone, and radius (one of the forearm bones). In this study, BMD of the lower spine was increased by:

  • 5.2% in women taking Actonel with estrogen*
  • 4.6% in women taking estrogen

Depending on the area of the thigh where BMD was measured, femoral BMD was increased by:

  • 2.7% to 3.7% in women taking Actonel with estrogen
  • 1.8% to 3.2% in women taking estrogen

And depending on the area of the forearm where BMD was measured, radial BMD was increased by:

  • 0.7% to 1.6% in women taking Actonel with estrogen
  • 0.4% to 1.7% in women taking estrogen

* Estrogen is sometimes used for osteoporosis in women who’ve gone through menopause.

Actonel for treating osteoporosis after menopause

Actonel is approved to treat osteoporosis in women who’ve gone through menopause.

Effectiveness for treating osteoporosis after menopause

In a clinical study involving women who’d gone through menopause, bone mineral density (BMD) was evaluated. (BMD is a measurement that shows how strong your bones are.)

After 3 years of treatment, BMD of the lower spine was increased by:

  • 5.0% in women taking Actonel
  • 0.8% in women taking a placebo (treatment with no active drug)

In addition, femoral (thigh bone) BMD was also measured in this study. After 3 years of treatment, depending on the area of the thigh bone where femoral BMD was measured, the BMD:

  • increased by 1.4% to 3.0% in women taking Actonel
  • decreased by 0.5% to 1.0% in women taking a placebo

Actonel for treating osteoporosis in men

Actonel is approved to treat osteoporosis in men.

Effectiveness for treating osteoporosis in men

In a clinical study involving men with osteoporosis, bone mineral density (BMD) was evaluated. BMD is a measurement that shows how strong your bones are.

In this study, men taking Actonel 35 mg once a week had increased BMD in their lower back, thigh bone, forearm, and hip bones. Compared with people taking a placebo (treatment with no active drug), people taking Actonel had their BMD increase by:

  • 4.5% more in their lower back
  • 1.1% more in their femoral neck (the area of the thigh bone that joins the hip)
  • 2.2% more in their hip bone
  • 1.5% more in their thigh bone

Actonel for preventing or treating osteoporosis due to glucocorticoid use

Actonel is approved to prevent or treat osteoporosis in adults who are using glucocorticoid therapy.

Glucocorticoids are a type of corticosteroid treatment. If you take glucocorticoids over a long period of time, you have an increased risk of osteoporosis. This is because these steroids may decrease the density of your bones.

For these uses, Actonel can be given to people who are just starting or continuing on with glucocorticoid treatment that’s equivalent to 7.5 mg of prednisone daily. And people taking Actonel for this use should also be taking calcium and vitamin D if their doctor recommends it.

Effectiveness for preventing osteoporosis that’s due to glucocorticoid therapy

In a clinical study of adults with osteoporosis due to glucocorticoids, people taking Actonel had a 70% lower risk of bone fracture compared with people taking a placebo. (A placebo is a treatment with no active drug.)

Effectiveness for treating osteoporosis that’s due to glucocorticoid therapy

In a clinical study of people with osteoporosis who were currently using glucocorticoids, bone mineral density (BMD) was evaluated. (BMD is a measurement that shows how strong your bones are.)

In this study:

  • people taking Actonel had the BMD in their lower back BMD increase by 2.7% more than did people taking a placebo (treatment with no active drug)
  • people taking Actonel had the BMD in their femur (thigh) bone increase by 1.6% to 1.9%* more than did people taking a placebo

* This percentage range varied depending on the area of the thigh where BMD was measured.

Actonel for Paget’s disease

Actonel is approved to treat Paget’s disease of the bone in adults. With this disease, your bones become soft and weakened, and can break more easily than usual. Bone pain and bone deformities may also occur with Paget’s disease.

For this use, Actonel treatment is typically only given for 2 months at a time. After 2 months of treatment, your doctor can monitor you to see if Paget’s disease comes back. If it does come back, your doctor may recommend another treatment course with Actonel.

Effectiveness for Paget’s disease

In people with Paget’s disease, blood levels of alkaline phosphatase (ALP) are used to monitor bone health. (Levels of this enzyme are higher than normal in people with Paget’s disease.)

In clinical studies of people with Paget’s disease the following results were seen:

  • after taking Actonel for 6 months, 77% of people had normal ALP levels
  • 16 months after stopping Actonel, 53% of people continued to have normal ALP levels

In the same study, treatment with Actonel was compared with that of another drug called Didronel.* (Actonel and Didronel are both approved to treat Paget’s disease, but they work in different ways.) This portion of the study showed that:

  • after taking Didronel for 6 months, 10.5% of people had normal ALP levels
  • 16 months after stopping Didronel, 14% of people continued to have normal ALP levels

* Didronel has been discontinued and it’s no longer available on the market.

Actonel and children

Actonel isn’t approved for use in people younger than 18 years of age. This drug was studied in children, but it didn’t meet certain requirements to be FDA-approved for use in children.

Actonel can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Actonel and other medications

Using certain medications with Actonel could decrease how well Actonel is able to work in your body. Below, we describe a group of medications that may affect Actonel in this way.

Before taking Actonel, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about how other drugs may affect Actonel, ask your doctor or pharmacist.

Actonel and antacids

Taking Actonel with antacids may cause Actonel to not work as well in your body. Antacids are used to treat heartburn.

Examples of antacids that may affect how Actonel works include:

  • calcium carbonate (Alka-Seltzer, Tums)
  • aluminum hydroxide/magnesium hydroxide/simethicone (Maalox, Mylanta)
  • calcium hydroxide/magnesium hydroxide (Rolaids)

If you need to take antacids while you’re using Actonel, it’s recommended that you take the antacids later in the day than when you take Actonel. (And keep in mind that Actonel should be taken in the morning.) But be sure to talk with your doctor about when you should take doses of Actonel and antacids.

Actonel and herbs and supplements

Using certain supplements with Actonel could decrease how well Actonel is able to work in your body. Below, we describe supplements that may affect Actonel in this way.

To be safe, check with your doctor or pharmacist before using any herbs or supplements while you’re taking Actonel.

Actonel and calcium supplements

While you’re taking Actonel, your doctor may recommend that you take a calcium and vitamin D supplement. They may do so if:

  • your diet doesn’t provide you with enough calcium and vitamin D, or
  • you’re using Actonel to treat Paget’s disease

But keep in mind that calcium supplements you’re using will need to be taken at a different time of day than Actonel is taken. Taking these supplements too close to the time when you take Actonel may cause Actonel not to work as well as it should.

If you’re taking calcium supplements with Actonel, talk with your doctor about when you should take doses of the supplements.

Actonel and foods

Actonel isn’t known to interact with any foods. However, it’s important that you don’t ingest any foods or beverages, other than a glass of water, for at least 30 minutes after taking Actonel. This is because taking Actonel with liquids other than water or eating too soon after taking Actonel may prevent your body from properly absorbing Actonel.

Actonel and lab tests

Actonel is known to interact with certain agents used to diagnose bone conditions. Called bone-imaging agents, these substances are used for certain tests to help doctors look for problems in your bones.

Because Actonel affects how your bones are made, it can interfere with these types of tests. Be sure to tell your doctor about all the medications you take, including Actonel. It’s important to do this before you have any sort of medical test, including a bone-imaging test.

Actonel is approved for certain bone conditions, including osteoporosis and Paget’s disease.

While you’re taking Actonel, your doctor may recommend that you take a calcium and vitamin D supplement. They’ll recommend doing so if:

  • your diet doesn’t provide you with enough calcium and vitamin D, or
  • you’re using Actonel to treat Paget’s disease

But keep in mind that calcium supplements you’re using will need to be taken at a different time of day than Actonel is taken. Taking these supplements too close to the time when you take Actonel may cause Actonel not to work as well as it should.

If you’re taking calcium supplements with Actonel, talk with your doctor about when you should take doses of the supplements.

As with all medications, the cost of Actonel can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial assistance

If you need financial support to pay for Actonel, help is available. NeedyMeds lists programs that may provide assistance to lower the cost of Actonel. For more information and to find out if you’re eligible for support, visit the program website.

Generic version

Actonel is available in a generic form called risedronate. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs.

If your doctor has prescribed Actonel and you’re interested in using risedronate instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

Actonel comes as tablets that are taken by mouth. How often you’ll take Actonel varies depending on the strength of the drug your doctor prescribes and the condition you’re treating. You should take Actonel according to your doctor’s or healthcare provider’s instructions.

Here are some tips for taking Actonel correctly and safely:

  • Actonel must be taken on an empty stomach, as soon as you wake up each day. You should take Actonel with a full glass of water. And be sure to take it before taking any other medications or consuming any other liquids or foods.
  • You should wait at least 30 minutes after taking Actonel before taking other medications or consuming any liquids or foods. But if you’re taking calcium supplements or antacids, you should wait several hours to take them after you’ve taken Actonel. Taking these products too soon after taking Actonel may prevent Actonel from working as well as it should.
  • You’ll need to take Actonel while sitting up or standing. And you should remain in one of these upright positions for at least 30 minutes after taking your dose. You shouldn’t lie down during this period of time. This is because Actonel can cause heartburn and may even damage your esophagus (the muscular tube that connects your mouth and stomach). Sitting upright or standing for at least 30 minutes helps prevent Actonel from flowing back from your stomach into your esophagus.
  • To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Actonel with food

Actonel must be taken on an empty stomach. This medication should be taken with a full glass of water. Then you should wait at least 30 minutes before ingesting any other liquids or foods.

Can Actonel be crushed, split, or chewed?

No, Actonel tablets shouldn’t be crushed, split, or chewed. Instead, Actonel tablets should be swallowed whole with a glass of water.

Actonel is approved for certain bone conditions, including osteoporosis and Paget’s disease.

With osteoporosis, your bones become thin and weak. And with this condition, bone fractures can occur more easily than usual. With Paget’s disease, your bones become soft and weak, and they can break more easily than usual. Bone pain and deformities may also occur with Paget’s disease.

What Actonel does

Actonel belongs to a group of drugs called bisphosphonates. These drugs work by slowing your body’s natural breakdown of bone. And they help to increase the thickness of your bone tissue.

Specifically, Actonel works by decreasing the activity of cells in your body called osteoclasts. These cells break down bone cells as your bone tissue makes new bone cells. With the action of osteoclasts being slowed, your bone cells aren’t broken down as quickly as usual. This helps to improve the strength and thickness of your bone tissue.

How long does it take to work?

Actonel starts to work in your system right away. In fact, Actonel helps to reduce breakdown of your bone tissue within 14 days of use.

It isn’t known if Actonel is safe to use during pregnancy. Animal studies have shown some risk to developing pregnancies when Actonel was given to pregnant females. However, animal studies don’t always predict what will happen in humans.

If you become pregnant or think you may be pregnant while taking Actonel, talk with your doctor right away. The manufacturer of Actonel recommends that you stop taking Actonel once a pregnancy is confirmed. Your doctor can recommend a treatment option that’s best for you.

It’s not known if Actonel is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Actonel.

For more information about taking Actonel during pregnancy, see the “Actonel and pregnancy” section above.

It’s not known if Actonel passes into human breast milk. If you’re breastfeeding, talk with your doctor about the benefits and risks of using Actonel.

This drug comes with several precautions. Before taking Actonel, talk with your doctor about your health history. Actonel may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Severe kidney problems. Actonel isn’t recommended for people with severe kidney problems. If you have decreased kidney function, talk with your doctor before starting Actonel. They can recommend whether it’s safe for you to take this drug.
  • Problems with your esophagus. If you have problems with passing material through your esophagus, you shouldn’t take Actonel. (Your esophagus is the muscular tube that connects your mouth and stomach.) Talk with your doctor about any issues with your esophagus before starting Actonel.
  • Low calcium levels. You shouldn’t start taking Actonel if your blood calcium levels are low. In this case, your doctor may treat the low levels before you start taking Actonel. In addition, your doctor may order blood tests to check your calcium levels while you’re taking Actonel. If your levels become low, your doctor may recommend treatment to increase the levels.
  • Differences in physical ability. Actonel shouldn’t be used by people who are unable to stand or sit upright for at least 30 minutes after taking the drug. If you think this may be an issue for you, be sure to talk with your doctor before taking Actonel.
  • Allergic reaction. If you’ve had an allergic reaction to Actonel or any of its ingredients, you shouldn’t take Actonel. Ask your doctor what other medications are better options for you. And if you’re unsure of your medication allergies, talk with your doctor.
  • Pregnancy. It’s not known if Actonel is safe to use during pregnancy. For more information, see the “Actonel and pregnancy” section above.
  • Breastfeeding. It isn’t known if Actonel passes into human breast milk. For more information, see the “Actonel and breastfeeding” section above.

Note: For more information about the potential negative effects of Actonel, see the “Actonel side effects” section above.

Using more than the recommended dosage of Actonel can lead to serious side effects. Do not use more Actonel than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

  • muscle cramps
  • spasms or twitching of the muscles
  • tingling or numbness in your fingers, toes, or mouth
  • confusion

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Actonel from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Actonel tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C). They should be kept in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Actonel and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Actonel is indicated for the following conditions:

  • treatment and prevention of osteoporosis in postmenopausal women
  • treatment of osteoporosis in men to increase bone mass
  • treatment and prevention of osteoporosis due to glucocorticoid use
  • treatment of Paget’s disease

Administration

Actonel comes as tablets that are administered by mouth. Dosage varies by the condition being treated. Please see the “Actonel dosage” section above for more information on administration schedules.

Mechanism of action

Actonel contains the bisphosphonate risedronate. Risedronate acts by slowing bone cell turnover and reducing resorption to slow loss of bone and help increase bone thickness.

Pharmacokinetics and metabolism

Absolute bioavailability of Actonel is up to 0.63% following oral administration. Steady-state concentration is reached within 57 days of daily dosing. The elimination half-life of Actonel is approximately 23 days.

Contraindications

Actonel is contraindicated in people with the following conditions:

  • esophageal abnormalities that delay emptying of the esophagus, such as stricture or achalasia
  • physical inability to be standing or sitting upright for at least 30 minutes
  • hypocalcemia
  • hypersensitivity to Actonel or any of its ingredients

Storage

Actonel should be stored at room temperature (68°F to 77°F/20°C to 25°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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