Linzess is a brand-name prescription medication. It’s FDA-approved to treat the following digestive conditions in adults:

Drug details

Linzess belongs to a class of medications called guanylate cyclase-C agonists. It comes as an oral capsule. Linzess is available in strengths of 72 micrograms (mcg), 145 mcg, and 290 mcg.

Effectiveness

For information about the effectiveness of Linzess, see the “Linzess uses” section below.

Linzess is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Linzess contains the active drug linaclotide.

Linzess can cause mild or serious side effects. They may vary depending on which condition the drug is used to treat. The following lists contain some of the key side effects that may occur while taking Linzess. These lists do not include all possible side effects.

For more information about the possible side effects of Linzess, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or 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 Linzess, you can do so through MedWatch.

Mild side effects

Mild side effects* of Linzess can include:

Most of these side effects may go away within a few days to a couple of weeks. However, 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 Linzess. To learn about other mild side effects, talk with your doctor or pharmacist, or see the Linzess prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Linzess 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* of Linzess can include:

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Linzess.

Headache

Although headache was not a common side effect in people who took Linzess in clinical trials, it may still occur.

Headache was reported only in trials of people who took Linzess for irritable bowel syndrome with constipation (IBS-C). People who took Linzess for chronic idiopathic constipation (CIC) did not report headache.

A headache can cause pain that’s throbbing, sharp, or dull. You may feel pain on both sides of your head or just one.

What you can do

If you have headaches that are frequent or bothersome while taking Linzess, talk with your doctor. They may recommend an over-the-counter treatment option, such as acetaminophen (Tylenol), to ease your discomfort.

Diarrhea

Diarrhea may occur during treatment with Linzess. This was the most common side effect in people who took the drug in clinical trials. In most cases, the diarrhea wasn’t serious. However, there were reports of severe diarrhea.

Diarrhea occurred about as often whether people took Linzess for IBS-C or CIC.

Diarrhea was the most common reason that people were prescribed a lower dose or stopped taking the medication.

Diarrhea usually starts to occur within the first 2 weeks after beginning Linzess treatment.

Symptoms of diarrhea can include bloating, abdominal pain, and stool that’s loose and watery. With severe diarrhea, you tend to pass the stool more forcefully and more often.

Severe diarrhea can sometimes lead to dehydration if you lose too much fluid. Symptoms of dehydration may include:

  • dry mouth or dry eyes
  • feeling thirsty
  • headache
  • feeling dizzy

What you can do

If you have severe diarrhea while taking Linzess, talk with your doctor. They can help determine if you should continue treatment with the drug.

If you develop any symptoms of dehydration, see a doctor right away.

To help prevent diarrhea and dehydration, your doctor will likely recommend staying hydrated and consuming electrolytes. (These are chemicals that help keep your body hydrated.) Your doctor may recommend sipping water throughout the day or drinking rehydrating solutions such as Gatorade or Pedialyte.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Linzess.

Symptoms of a mild allergic reaction can include:

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 an allergic reaction to Linzess, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Linzess isn’t known to cause long-term side effects.

Most of the side effects that people reported in clinical trials occurred only while they took Linzess. This means that side effects (such as diarrhea or bloating) may occur throughout Linzess treatment. It’s also possible that side effects could improve as you continue to take the drug. If your doctor has you stop Linzess treatment, the side effects should go away.

If you have any questions about what to expect with Linzess, talk with your doctor.

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

  • the type and severity of the condition you’re taking Linzess to treat
  • side effects you develop with Linzess

In some cases, your doctor may start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

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

Drug forms

Linzess comes as an oral capsule.

Drug strengths: 72 mcg, 145 mcg, 290 mcg

Linzess is available in the following strengths: 72 micrograms (mcg), 145 mcg, and 290 mcg.

Dosage for irritable bowel syndrome with constipation

To treat irritable bowel syndrome with constipation, the typical dosage of Linzess is 290 mcg per day. For this use, the lowest dose and the maximum dose are also 290 mcg.

Dosage for chronic idiopathic constipation

To treat chronic idiopathic constipation, the typical dosage of Linzess is 145 mcg per day. The maximum dose that’s recommended is 145 mcg.

If your symptoms aren’t severe or you have side effects from the 145-mcg dose, your doctor may prescribe a lower dosage: 72 mcg once per day. The lowest dose of Linzess that’s recommended is 72 mcg.

What if I miss a dose?

If you miss a dose of Linzess, skip the missed dose. Then take your next dose as scheduled the following day. You should not take two doses of Linzess at once to try to make up for a missed dose.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to take this drug long term?

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

The Food and Drug Administration (FDA) approves prescription drugs such as Linzess to treat certain conditions. Linzess may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Linzess for irritable bowel syndrome with constipation (IBS-C)

Linzess is approved to treat a digestive condition called irritable bowel syndrome with constipation (IBS-C). The drug is for use in adults.

IBS-C causes constipation along with other symptoms such as:

  • bloating
  • abdominal pain or cramping
  • gas
  • feeling like you need to use the bathroom after a bowel movement

Effectiveness for IBS-C

Linzess is an effective treatment option for adults with IBS-C. In fact, treatment guidelines from the American Journal of Gastroenterology recommend guanylate cyclase-C agonists, such as Linzess, as options for IBS-C. For information about how Linzess performed in clinical trials, see the drug’s prescribing information.

Linzess for chronic idiopathic constipation (CIC)

Linzess is approved to treat a digestive condition called chronic idiopathic constipation (CIC). With CIC, you’re frequently constipated for an unknown reason. “Chronic” means long term, and “idiopathic” means the cause isn’t known.

Symptoms of CIC can include experiencing the following within a 3-month period:

  • passing stools that are lumpy, hard, or like pebbles
  • having fewer than three bowel movements per week
  • having trouble emptying your bowels

Effectiveness for CIC

Linzess is an effective medication for adults with CIC. In fact, the drug is mentioned as a treatment option for people with CIC in guidelines from The American Journal of Managed Care. For information about how Linzess performed in clinical trials, see the drug’s prescribing information.

Linzess and children

Linzess is not approved for use in children. It’s not known if the drug is safe or effective for this age group. In fact, the drug has a boxed warning about a risk of serious dehydration in children younger than age 2 years. This is a serious warning from the FDA. For details, see the FDA warning in the “What is Linzess?” section above.

If your child has IBS-C or CIC, talk with their doctor about other treatment options.

Here are answers to some frequently asked questions about Linzess.

Is Linzess prescribed for weight loss or weight gain?

No, Linzess is not approved for weight loss or weight gain. In the drug’s studies, the reported side effects did not include any changes in weight.

However, Linzess may cause diarrhea, which can be severe at times. Having diarrhea over an extended period may lead to weight loss.

In addition, abdominal distension (also known as bloating) is a side effect of Linzess. It’s possible for bloating to cause weight gain.

If you’re interested in help with weight loss or weight gain, talk with your doctor. They can help determine the best treatment plan for you.

Is Linzess used for other digestive conditions, such as opioid-induced constipation, diarrhea, or gastroparesis?

At this time, Linzess is not approved to treat opioid-induced constipation (OIC), diarrhea, or gastroparesis. Linzess is approved to treat only irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). However, the medication may be used off-label for other digestive conditions. Off-label drug use is when a drug that the Food and Drug Administration (FDA) has approved is prescribed for a purpose other than what it’s approved for.

OIC is a condition that may occur in people taking opioids because constipation is sometimes a side effect of opioid treatment. A study of Linzess showed that the drug may ease constipation related to opioid medications.

Linzess can cause diarrhea as a side effect. In some cases, the diarrhea can be severe. Due to this risk, it’s unlikely that your doctor will recommend Linzess for diarrhea, including irritable bowel syndrome with diarrhea.

There haven’t been any clinical trials to see whether Linzess is a safe or effective treatment option for gastroparesis. This is a condition that can cause food to move slowly through your digestive system. Linzess works to speed up your digestion and decrease abdominal pain, so it may ease symptoms of gastroparesis. However, at this time, the drug is not approved for this use.

If you’re interested in Linzess for OIC, talk with your doctor. They can also advise you on treatments for diarrhea and gastroparesis.

Does Linzess cause depression?

Linzess isn’t known to cause depression. This side effect was not reported in clinical trials of people who took the drug.

It’s possible that other medications used to treat IBS-C or CIC may cause mood changes, such as depression. Examples of these medications include prucalopride (Motegrity) and lubiprostone (Amitiza).

You may also be at an increased risk of developing depression due to IBS-C or CIC. This is because of possible emotional effects of the conditions, such as feeling embarrassed or uncomfortable.

If you’d like to learn about depression and potential treatments while taking Linzess, talk with your doctor.

Is Linzess a controlled substance?

No, Linzess is not a controlled substance. A controlled substance is a medication that the government regulates, typically because of the risk of misuse or dependence.

Misuse refers to taking a medication in a different way than how it was prescribed. Dependence occurs when your body becomes used to taking a drug, and then you need it to function as you usually do.

Linzess is not known to cause misuse or dependence.

Is Linzess a laxative?

No. Linzess is not a laxative. Like Linzess, laxatives can help relieve constipation, but they work in different ways than Linzess. Laxatives help loosen stool so you don’t strain as much when having a bowel movement. In addition, laxatives may help bowel movements occur more often. Examples of laxatives include:

  • polyethylene glycol (MiraLAX)
  • docusate (Colace)
  • bisacodyl (Dulcolax)
  • magnesium hydroxide (milk of magnesia)
  • senna (Senokot)

Laxatives are usually a short-term treatment, while Linzess is typically taken long term.

Linzess works by increasing the amount of fluid in your intestines. The drug also helps food move more quickly through your digestive tract. In addition, Linzess may ease pain in your digestive system. For more information, see the section below called “How Linzess works.”

Should I expect nausea with Linzess?

Nausea was not a side effect reported in clinical trials of people who took Linzess. However, nausea has been reported since the drug came on the market.

You may be nauseous due to the constipation you experience from IBS-C or CIC. Nausea is a symptom of constipation.

Your doctor may be able to suggest possible treatments for any nausea you have.

Other drugs are available that can treat your condition, including brand-name and generic alternatives. Some may be a better fit for you than others. If you’re interested in finding an alternative to Linzess, 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 drug use is when a drug that the Food and Drug Administration (FDA) has approved is prescribed for a purpose other than what it’s approved for.

Alternatives for irritable bowel syndrome with constipation

Examples of other drugs that may be used to treat irritable bowel syndrome with constipation include:

  • plecanatide (Trulance)
  • lubiprostone (Amitiza)
  • tegaserod (Zelnorm)
  • polyethylene glycol (MiraLAX)
  • sennosides (Senokot)
  • bisacodyl (Dulcolax)

Alternatives for chronic idiopathic constipation

Examples of other drugs that may be used to treat chronic idiopathic constipation include:

  • plecanatide (Trulance)
  • lubiprostone (Amitiza)
  • polyethylene glycol (MiraLAX)
  • sennosides (Senokot)
  • bisacodyl (Dulcolax)
  • prucalopride (Motegrity)

Linzess is used to treat certain digestive system problems. Specifically, Linzess works to treat constipation in people with:

IBS-C causes constipation along with other symptoms such as bloating or abdominal pain. With CIC, you’re often constipated for an unknown reason.

It’s believed that Linzess works by increasing the amount of fluid in your intestines. The drug also helps food move more quickly through your digestive tract. This makes bowel movements occur more often, which may help ease symptoms of constipation. How a drug works is called its mechanism of action.

In addition, Linzess may lessen pain in your digestive system by reducing the contraction of digestive muscles and relaxing nerves that sense pain. This may also help treat your symptoms of IBS-C or CIC.

How long does it take to work?

Linzess should begin working as soon as you take your first dose. However, it may take some time before you notice your symptoms ease. It can take about 1 week before you notice relief from constipation symptoms. The drug may continue to work even better over the next 12 weeks.

Because Linzess does not absorb well into the body, it’s not known what the half-life of the drug is. (A medication’s half-life is how much time it takes for the body to eliminate half a dose.) Instead of being absorbed into your blood, Linzess works in your digestive system.

Are there any symptoms that Linzess has stopped working?

If your symptoms of IBS-C or CIC begin to come back, it could mean that Linzess has stopped working for you. Symptoms of these conditions can include:

  • abdominal pain
  • constipation
  • straining when trying to have a bowel movement
  • infrequent bowel movements

If you notice that your symptoms seem to be coming back or worsening, talk with your doctor. They may recommend a different treatment.

You may wonder how Linzess compares with other medications that are prescribed for similar uses. To find out how Linzess compares with Trulance, see this article.

As with all medications, the cost of Linzess can vary. To find current prices for Linzess capsules in your area, check out GoodRx.com.


The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Linzess. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

Before approving coverage for Linzess, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Linzess, contact your insurance company.

Financial assistance

If you need financial support to pay for Linzess, help is available. AbbVie, the manufacturer of Linzess, offers a Linzess Savings Program. For more information and to find out if you’re eligible for support, call 855-859-5614 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Linzess may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Linzess, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Linzess is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

You should take Linzess according to the instructions your doctor gives you.

Linzess comes as an oral capsule that you swallow. If you have difficulty swallowing Linzess, you can open the capsule and mix the contents in room-temperature water or applesauce. Linzess can also be given through a nasogastric or gastrostomy feeding tube if needed. (To learn more, see “Can Linzess be crushed, split, or chewed?” below.)

When to take

You’ll take your dose of Linzess in the morning, at least 30 minutes before your first meal of the day.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have trouble opening medication bottles, ask your pharmacist if they can put Linzess in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Linzess with food

Be sure to take Linzess on an empty stomach. Taking Linzess with food may increase side effects from the drug, such as diarrhea. However, you may sprinkle the capsule contents on applesauce to take a dose if needed. (For more information, see “Can Linzess be crushed, split, or chewed?” below.)

Can Linzess be crushed, opened, or chewed?

You should swallow Linzess capsules whole. You should not crush or chew them.

If you have difficulty swallowing Linzess, you can open the capsule and mix the contents in room-temperature water or applesauce.*

Linzess can also be given through a nasogastric or gastrostomy feeding tube if needed.* A nasogastric feeding tube is inserted into your nose and goes to your stomach. A gastrostomy feeding tube is inserted into your stomach through your abdomen.

* For details, see the Linzess medication guide.

Linzess is not known to cause withdrawal or drug dependence.

Withdrawal can occur when you stop taking a medication that your body is used to. Withdrawal symptoms typically include nausea, sweating, and mood changes.

Dependence can occur when you need to take a medication to feel as you normally do. (If you take a medication for a period of time, your body can get used to having it.)

Symptoms of constipation may come back if you stop taking Linzess. This is not considered withdrawal or dependence. However, when people in clinical trials stopped taking the drug for a time, it was called a “withdrawal period.” During this time, their symptoms seemed to worsen.

You should not stop taking Linzess unless you first speak with your doctor. If you have questions about ending your treatment, they can help.

There are no known interactions between Linzess and alcohol.

However, drinking alcohol may worsen some side effects of Linzess. For example, Linzess may cause headaches. The drug can also cause diarrhea, which may be severe. In some cases, severe diarrhea can lead to dehydration. Consuming alcohol can also cause headaches and dehydration. So if you drink alcohol during Linzess treatment, headaches and dehydration may become worse.

You can talk with your doctor about how much alcohol, if any, is safe for you to drink with Linzess.

Linzess is not known to interact with other medications or supplements. However, Linzess can interact with food.

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.

It’s important that before taking Linzess, you 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 drug interactions that may affect you, ask your doctor or pharmacist.

Linzess and foods

It’s important to take Linzess on an empty stomach, at least 30 minutes before your first meal of the day. Taking the medication with food may increase its side effects, such as diarrhea.

It’s not known if it’s safe to take Linzess during pregnancy or if the drug affects a developing fetus. There haven’t been clinical trials of the drug during pregnancy. However, Linzess works mostly in the digestive tract and is not well absorbed into the blood. This means a developing fetus would likely be exposed to a small amount of the drug.

In animal studies, no congenital anomalies (commonly known as “birth defects”) were reported. The studies did show harmful effects in pregnant animals and their fetuses when Linzess was given in very high doses. It’s important to note that animal studies don’t always indicate what may happen in humans.

The Food and Drug Administration (FDA) no longer uses pregnancy categories to help determine if a medication is safe to take during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor before taking Linzess. They can help determine the right treatment plan for you during your pregnancy.

It’s not known if Linzess 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 Linzess.

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

It isn’t known for sure if it’s safe to breastfeed while taking Linzess. Linzess is not believed to pass into breast milk. This means that a breastfed child will likely not be exposed to the drug.

It’s not known if Linzess affects the ability to produce breast milk.

If you’re breastfeeding or thinking about it, talk with your doctor before starting Linzess treatment. They can help you determine if the drug is right for you.

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

Overdose symptoms

Symptoms of an overdose can include diarrhea.

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 its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

This drug comes with several precautions.

FDA warning: Risk of serious dehydration in children younger than age 2 years

This drug has a boxed warning about a risk of serious dehydration in children younger than age 2 years. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Although Linzess was not tested in children younger than age 2 years, the drug was tested in animal studies. The results showed that young animals given Linzess had an increased risk of dehydration due to severe diarrhea. In some cases, this led to death. Due to these risks, doctors typically will not prescribe Linzess for children younger than age 2 years. At this time, Linzess is approved for use only in adults.

For more information about this boxed warning, talk with your doctor.

Other precautions

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

  • Intestinal obstruction. Linzess can make food move more quickly than usual in the digestive tract. So if you have an intestinal obstruction, the drug may worsen it. Due to this risk, doctors typically will not prescribe Linzess if you have an intestinal obstruction. Your doctor can advise you on other treatment options.
  • Allergic reaction. If you’ve had an allergic reaction to Linzess or any of its ingredients, your doctor will likely not prescribe Linzess. Ask your doctor what other medications may be better options for you.
  • Pregnancy. It is not known if it’s safe to take Linzess during pregnancy. For more information, see the “Linzess and pregnancy” section above.
  • Breastfeeding. In some cases, it may be safe to breastfeed while taking Linzess. For more information, see the “Linzess and breastfeeding” section above.

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

When you get Linzess 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 with your pharmacist about whether you might still be able to use it.

Storage

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

You should store Linzess capsules at room temperature of 77°F (25°C). If needed, you can keep the medication between 59°F and 86°F (15°C and 30°C).

Be sure to store Linzess in its original container from the pharmacy. Bottles of Linzess contain a packet of desiccant, which is a substance that helps absorb moisture. You should not remove the desiccant from the bottle. Also, be sure to keep the bottle tightly closed and in a dry area away from moisture.

Disposal

If you no longer need to take Linzess 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 about how to dispose of your medication.

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 another 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.