Natesto (testosterone) is a brand-name prescription medication. It’s FDA-approved for use in adult males* as replacement therapy for low or missing testosterone caused by certain conditions.

Low or missing testosterone is also known as male hypogonadism. This condition has many possible causes, including your testicles not producing enough testosterone.

Natesto has certain limitations of use. See the “Natesto uses” section below for more information.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Drug details

Natesto contains a copy of the body’s natural testosterone. Testosterone is an androgen (male sex hormone). Natesto belongs to a class of drugs that are also called androgens. (A drug class is a group of drugs that work in a similar way.)

Natesto comes as a gel that you apply to the insides of your nostrils using a pump. Each full press of the pump contains 5.5 milligrams of testosterone in 0.122 grams of gel. You’ll typically use Natesto three times per day.

Is Natesto a controlled substance?

Yes. Natesto’s active drug, testosterone, is a Schedule III controlled substance. This means the drug has accepted medical uses, but it may also lead to misuse or dependence. For this reason, there are additional laws around prescribing and using controlled substances such as Natesto.

Note: The testosterone in Natesto is an anabolic steroid, which is banned for use in competitive sports.

Effectiveness

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

Natesto is available only as a brand-name medication. Currently, it’s not 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.

Here are answers to some frequently asked questions about Natesto.

Where can I find reviews from people who’ve had Natesto treatment?

Sometimes, drug manufacturers publish people’s reviews of the drug on the drug’s site. But there aren’t any reviews of Natesto nasal gel available.

If you have questions about how others have experienced Natesto treatment, your doctor can provide more information. However each person’s body can experience treatment differently, however. Make sure to talk with your doctor or pharmacist if you have questions about what to expect.

Are there coupons for Natesto?

Possibly. You can search for Natesto coupons at GoodRx.com. These coupons can be redeemed to help lower the retail price of prescription drugs at certain pharmacies.

If you’re eligible, the manufacturer of Natesto also offers a savings card to help lower copay costs. To learn more about the Natesto Savings Program, see the “Natesto cost” section below.

Was Natesto discontinued at some point?

No. Natesto hasn’t been recalled or permanently discontinued in the United States (U.S.).

In 2016, the supply of Natesto may have been affected for a short time. This is because Natesto’s manufacturer was searching for a new company to distribute and market the drug in the U.S. But this was not due to concerns about Natesto’s safety or effectiveness.

Your doctor or pharmacist can give you details about this if you have more questions.

How do Natesto and Androgel compare?

Natesto and Androgel are both prescription testosterone replacement therapies. Both drugs are approved to treat male* hypogonadism that’s caused by certain medical conditions. And they’re both considered effective treatment options by the American Urological Association.

Natesto and Androgel contain the same form of testosterone, so they can cause similar side effects. Both drugs come as a gel, but they’re applied differently:

  • you apply Natesto inside your nostrils using a pump, typically 3 times per day
  • you apply Androgel directly to certain areas of your skin, typically once per day

With Androgel, the drug can transfer from your skin to others’ skin. This can be harmful, especially for females* or children. This isn’t a concern with Natesto.

To learn more about how these drugs compare, you can talk with your doctor or pharmacist.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

The following information describes dosages that are commonly used or recommended for Natesto as a testosterone replacement therapy. However, be sure to take the dosage your doctor prescribes for you.

Your doctor will determine the best dosage to fit your needs. For example, your dosage may depend on your testosterone levels or whether you have side effects.

Drug forms and strengths

Natesto comes as an intranasal gel (a gel that you apply to the insides of your nostrils). It contains the active drug testosterone.

The gel comes in a metered dose pump (a pump that dispenses specific doses of the drug). Each full press of the pump contains 5.5 milligrams (mg) of testosterone in 0.122 grams (g) of gel. The pump can be used 60 times and contains a total of 11 g of testosterone. This is about a 10-day supply.

Note: Natesto isn’t a nasal spray. You apply the gel only on the insides of your nostrils, where it can be absorbed by your body.

Dosage for testosterone replacement therapy

Typically, you should place one full press of the Natesto pump (5.5 mg of testosterone) into each nostril for a total of 11 mg, three times a day. This equals a total daily dosage of 33 mg.

Each dose should be taken 6 to 8 hours apart. And try to take your doses around the same times each day.

What if I miss a dose?

If you miss a dose of Natesto, try to take it as soon as you remember. If there are less than 6 hours until your next dose, skip the missed dose and take your next dose as usual.

Do not use more Natesto than usual, or use it more often, to make up for any missed doses.

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.

Will I need to use this drug long term?

Typically, Natesto is meant to be used as a long-term treatment.

If you and your doctor determine that Natesto is safe and effective for you, you’ll likely take it long term. Make sure to talk with your doctor about how long you can expect to take Natesto.

As with all medications, the cost of Natesto can vary. To find current prices for Natesto gel 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 Natesto. 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 or your insurance company.

Before approving coverage for Natesto, 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 Natesto, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Natesto, or if you need help understanding your insurance coverage, help is available.

Acerus Pharmaceuticals Corporation, the distributor of Natesto, offers programs called Natesto at Home and the Natesto Savings Program. For more information and to find out if you’re eligible for support, visit the programs’ website. You can also call 877-300-1833 for Natesto at Home and 855-390-0162 for the Natesto Savings Program.

For more information, check out this article to learn more about saving money on prescriptions.

Mail-order pharmacies

Natesto 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 Natesto, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your 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

Natesto isn’t 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.

If you’re interested in a generic form of testosterone replacement therapy, talk with your doctor or pharmacist.

Natesto can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Natesto. These lists do not include all possible side effects.

For more information about the possible side effects of Natesto, 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: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you would like to notify the FDA about a side effect you’ve had with Natesto nasal gel, you can do so through MedWatch.

Mild side effects

Mild side effects* of Natesto can include:

  • symptoms that affect your nose, such as dryness, pain, scabbing, or bleeding
  • a common cold or its symptoms, such as sneezing, cough, sore throat, and runny or stuffy nose
  • other upper respiratory infections, such as a sinus infection
  • headache
  • erections that are more frequent than usual or last longer than usual
  • distorted (unusual) taste or smell

Most mild side effects may go away within a few days or a couple of weeks of using Natesto. 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 Natesto. To learn about other mild side effects, talk with your doctor or pharmacist, or view Natesto’s patient information.

Serious side effects

Serious side effects from using Natesto 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:

* 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.

Blood clots and stroke

It’s possible to develop certain types of blood clots while using Natesto. Blood clots weren’t seen in clinical studies of Natesto. But they have been reported with other testosterone replacement therapy drugs. (Natesto is a testosterone replacement therapy.)

With Natesto, blood clots may form in your legs or lungs. A leg blood clot can cause swelling, warmth, pain, or redness. Lung blood clots may cause chest pain and shortness of breath.

These blood clots can lead to a stroke (lack of oxygen-rich blood flowing to the brain). Symptoms of a stroke may include:

Before prescribing Natesto, your doctor will evaluate your risk factors for blood clots. Make sure to tell them about any past or present health conditions you have before starting treatment.

If you have blood clot symptoms, call your doctor right away. If any symptoms feel life threatening or like you’re having a medical emergency, call 911 or your local emergency number. Your doctor will have you stop Natesto if you experience a blood clot.

High red blood cell counts

High levels of red blood cells are a possible side effect of Natesto. In clinical studies, this was a rare but serious side effect.

Having high red blood cell counts increases your risk of blood clots and stroke with Natesto (which is discussed in the section just above). You’ll have blood tests to check your counts before and during Natesto treatment.

Tell your doctor if you have a lasting headache or dizziness with Natesto. These could be signs of high red blood cell counts. Your doctor may adjust your Natesto dosage or recommend a different treatment for you.

Decreased sperm count

Natesto can cause sperm count (the number of sperm in your semen) to go down.

This side effect wasn’t reported in Natesto’s clinical studies. But other testosterone replacement therapies have caused decreased sperm counts.

Having a decreased sperm count may affect your fertility (your ability to conceive children). Reduced fertility has been seen with large doses of testosterone replacement therapies.

Talk with your doctor about your fertility risks with Natesto, especially if you’re planning to have children. They may suggest a different treatment for your condition. (And it’s important to note that you should use birth control to prevent pregnancy while you’re taking Natesto, if this applies to you and your partner.)

Liver damage

Liver damage is a possible side effect of Natesto. This wasn’t reported in clinical studies. But other testosterone replacement therapies have caused serious liver damage when taken in high doses or over a long time.

Contact your doctor right way if you notice signs of liver damage, such as:

  • jaundice (yellowing of your skin or the whites of your eyes)
  • abdominal (belly) pain
  • low appetite or unexplained weight loss
Allergic reaction

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

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

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 Natesto, 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.

Natesto is used as testosterone replacement therapy in adult males* who have low or missing testosterone due to certain conditions. Low or missing testosterone is also known as male hypogonadism.

Natesto contains a copy of the body’s natural testosterone. Testosterone is an androgen (male sex hormone). Natesto works by replacing the testosterone that your body lacks. This can reduce the symptoms of male hypogonadism.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

How long does it take to work?

Natesto starts to work shortly after your first dose. But it may take time for your testosterone to reach normal levels.

Your doctor will test your testosterone levels:

  • before starting Natesto,
  • about 4 weeks after starting the drug, and
  • periodically during your treatment

How long Natesto takes to work may depend on your starting testosterone levels and your treatment plan. It’s important to avoid missing doses because this can make it take longer for your testosterone levels to reach normal. But in clinical studies, many people’s testosterone levels reached normal levels after about 3 months of taking Natesto.

For questions about when you can expect Natesto to work for your condition, talk with your doctor.

The Food and Drug Administration (FDA) approves prescription drugs such as Natesto to treat certain conditions.

Natesto for testosterone replacement therapy

Natesto is approved for replacement therapy in adult males* with low or missing testosterone due to certain conditions.

Low or missing testosterone is also known as male hypogonadism. This may be:

  • primary hypogonadism, which is caused by a problem with your testicles
  • hypogonadotropic hypogonadism, which is caused by a problem with the hormones or processes needed for your body to make testosterone

Male hypogonadism may be present at birth, or it may develop later in life. Without enough testosterone, you may be at higher risk of certain health conditions, such as osteoporosis (weak or thin bones). And you may experience other negative effects, such as:

For more information on testosterone levels, our men’s health hub may be helpful.

Natesto is not approved to treat low testosterone that’s caused by aging. It’s also not approved for use in males under 18 years old. The drug’s safety and efficacy for this use and age group is unknown. Also, Natesto isn’t approved for use in females.*

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Effectiveness for testosterone replacement therapy

In a large clinical study, Natesto was an effective replacement therapy for low or missing testosterone. For details about how the drug performed in studies, you can visit Natesto’s manufacturer site.

According to guidelines from the American Urological Association, nasal forms of testosterone replacement (such as Natesto, which is a nasal gel) are effective for treating low or missing testosterone.

Natesto and children

Natesto is not approved for use in children. If you have questions about your child’s hormone levels talk with their doctor.

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

Alternatives for low or missing testosterone

Examples of other drugs used for testosterone replacement therapy include:

  • oral drugs (drugs taken by mouth), such as:
  • injectable drugs, such as:
    • testosterone undecanoate (Aveed)
    • testosterone cypionate (Depo-Testosterone)
  • skin implants, such as:
  • buccal tablets (taken by placing the tablet inside your cheek or next to your gums), such as:
    • testosterone buccal system (Striant)
  • topical products (which are applied to the skin), such as:
    • testosterone gel (Androgel)
  • skin patches, such as:
    • testosterone transdermal system (Androderm)

Drinking alcohol doesn’t affect how Natesto works in the body.

Natesto hasn’t been shown to cause liver problems. However, high doses of some types of testosterone replacement therapy have caused liver damage. (Natesto is a testosterone replacement therapy.) And excessive alcohol use can also harm your liver.

If you drink alcohol, talk with your doctor about whether it’s safe for you to drink while taking Natesto.

Natesto can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the risk of side effects or make them more severe.

Before using Natesto, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Sharing this information can help you avoid potential interactions.

Natesto doesn’t have any known interactions with foods, vitamins, herbs, or supplements. But you should still check with your doctor or pharmacist before using any of these products with Natesto.

Natesto and other medications

Below is a list of medications that can interact with Natesto. It’s possible that other drugs may also interact with Natesto, too. Before starting Natesto, ask your doctor or pharmacist if you’re at risk of any drug interactions.

Types of drugs that may interact with Natesto include:

  • Insulin. Natesto can decrease your blood glucose levels. If you have diabetes and you take insulin, your insulin dosage may need to be lowered while you’re taking Natesto.
  • Oral anticoagulants (blood thinners taken by mouth). Natesto may affect how well warfarin (Coumadin) or other oral blood-thinning drugs work. Your clotting time should be checked more often than usual during and after Natesto treatment.
  • Corticosteroids. Taking Natesto with corticosteroids can cause fluid retention (buildup of excess fluid in the body). Your doctor will check your fluid levels if you take Natesto along with a corticosteroid, such as prednisone (Rayos). If you also have heart, kidney, or liver disease, you’ll be monitored even more frequently during Natesto treatment.
  • Oxymetazoline. Oxymetazoline (Afrin) is a decongestant nasal spray. Using this product 30 minutes before taking Natesto can make your Natesto treatment less effective. It’s unclear if Natesto interacts with other nasal decongestants. Before using these types of products while you’re taking Natesto, talk with your doctor.

Make sure to take Natesto according to your doctor’s instructions.

Natesto comes as an intranasal gel, which is a gel that you apply to the inside of your nostrils. The gel comes in a metered dose pump (a pump that dispenses specific doses of the drug).

Typically, you’ll place one full press of the Natesto pump into each nostril, three times per day. Aim the pump away from the center of your nose, so that the tip gently touches the inside of your nostril.

The Natesto pump can be used 60 times, which typically is a 10-day supply. Before you start using a new pump, you should prime it according to the manufacturer’s directions. For these directions or for more detailed instructions about how to take Natesto, see its patient information. You can also talk with your doctor or pharmacist.

When to take

If your doctor prescribes three doses per day of Natesto, space out each dose by 6 to 8 hours. For example, use Natesto in the morning, at midday, and before bed. And try to take your doses around the same times each 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.

Natesto is not safe to use during pregnancy and is not approved for use in females.* Its active drug, testosterone, can harm a fetus. If you have questions about this, your doctor can provide more information.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Natesto and fertility

In large doses, testosterone replacement therapy (such as Natesto) may lower fertility. Fertility is your ability to conceive children.

Specifically, high doses could cause decreased sperm count (the number of sperm in your semen). See “Natesto side effects” above for details about this possible side effect.

If you’re planning to have children, talk with your doctor before starting Natesto.

Natesto is only approved for use in males.* To prevent pregnancy, you should use birth control during your Natesto treatment.

If you’re planning to have children, there aren’t any safety concerns if you continue to take Natesto. But it’s important to know that high doses of Natesto may decrease fertility (the ability to conceive children). Although the drug may decrease fertility, you should still use birth control if you want to prevent pregnancy during treatment.

Natesto is not approved for use in females* and should not be used during pregnancy. For more information, see the “Natesto and pregnancy” section above.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Natesto is not approved for use in females* and should not be taken while breastfeeding. If you have questions about this, talk with your doctor.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

This drug comes with several precautions.

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

  • Prostate cancer or male* breast cancer. Natesto may increase your risk of prostate cancer or breast cancer. Your doctor will monitor you for signs of prostate cancer before starting the drug, and periodically during your treatment. You should not take Natesto if you have prostate or breast cancer. It may be unsafe to use Natesto even if you’re in remission (periods of time with no signs of cancer). Talk with your doctor about your cancer history before starting Natesto.
  • Benign prostatic hyperplasia (BPH). If you have BPH (an enlarged prostate), using Natesto may worsen your symptoms, especially if you’re 65 years or older. Before starting Natesto, talk with your doctor about your prostate health. Your doctor may monitor your BPH while you take Natesto.
  • Certain nasal conditions. It’s not known if Natesto is safe or effective to use if you have a history of some nasal conditions. These include chronic (long-term) nasal allergies, nose or sinus surgery, a recent broken nose or deviated septum, and chronic sinus infections. This also includes inflammatory conditions that affect your nasal passages. Tell your doctor about your nasal health before starting Natesto.
  • Severe nasal congestion. Do not start or take Natesto during times of severe nasal congestion. Wait until your congestion clears to use the drug. If you have chronic congestion, ask your doctor about other testosterone replacement therapies that may work better for you.
  • Heart, liver, or kidney disease. Natesto may cause fluid retention (buildup of excess fluid in the body) and swelling. This can be especially harmful if you have heart, liver, or kidney disease. Your doctor will monitor you for swelling while taking Natesto. If you develop heart failure or other problems, they’ll have you stop Natesto and may prescribe a diuretic (also known as a water pill).
  • Sleep apnea or risk factors for sleep apnea. If you have sleep apnea, Natesto may worsen your symptoms. This is especially true if you have obesity, or if you have lung problems or other sleep apnea risk factors. Talk with your doctor about these risks before starting Natesto.
  • High blood calcium levels risk due to cancer. If you have cancer that increases your risk of high blood calcium levels, your doctor will monitor your blood calcium levels while you’re taking Natesto. Talk with your doctor if you have questions about this.
  • Body mass index (BMI) higher than 35. It’s unclear whether Natesto may be safe and effective in people with severe obesity (with a BMI higher than 35). Obesity also increases your risk of sleep apnea as a side effect of Natesto. Talk with your doctor about your BMI and whether this drug is right for you.
  • Allergic reaction. If you’ve had an allergic reaction to Natesto or any of its ingredients, you should not take Natesto. Ask your doctor what other medications are better options for you.
  • Pregnancy. Natesto is not approved for use in females* and should not be taken during pregnancy. For more information, see the “Natesto and pregnancy” section above.
  • Breastfeeding. Natesto is not approved for use in females and should not be taken while breastfeeding. For more information, see the “Natesto and breastfeeding” section above.

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

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Overdose of Natesto wasn’t seen in clinical studies. However, an overdose of an injectable form of testosterone (called testosterone enanthate [Xyosted]) has been reported. Natesto contains a slightly different form of testosterone and comes as a gel that you apply inside your nose.

To be safe and avoid serious side effects, do not use more than the recommended dosage of Natesto.

Overdose symptoms

Overdose of testosterone enanthate can rarely cause a stroke or death. Other symptoms can include:

What to do in case you take too much Natesto

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.

There haven’t been studies on whether Natesto can cause drug dependence. With dependence, you need the drug in order to function.

When taken as prescribed, testosterone replacement therapies don’t lead to dependence. Natesto is a testosterone replacement therapy.

However if you misuse Natesto, you could become dependent on the drug, both physically and mentally. Misuse refers to taking the drug differently than how it was prescribed, such as taking too much. Symptoms of Natesto misuse or dependence may include:

  • aggression or changes in mood or personality
  • heart problems
  • high blood testosterone levels

If you become dependent on Natesto, you may have withdrawal symptoms. These are side effects that occur if you stop the drug. Symptoms of Natesto withdrawal can include:

To limit these risks, make sure to use Natesto exactly as your doctor recommends. If you’re concerned about dependence or withdrawal with Natesto, talk with your doctor.

When you get Natesto from the pharmacy, the pharmacist will add an expiration date to the label on the packaging. 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.

Ideally, you should store your Natesto metered dose pump at room temperature.

Disposal

Keep in mind, each Natesto pump can be pressed 60 times, which is typically a 10-day supply. After 10 days, throw away your used pump into the trash. Make sure your children and pets cannot access it.

If you no longer need to use Natesto and have leftover, unused 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 possibly 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.