Tosymra (sumatriptan) is a brand-name prescription medication. It’s FDA-approved to treat migraine that occurs with or without aura in adults. Tosymra is an acute (fast-acting) treatment meant to stop a migraine episode that’s already started.

Migraine is a condition that typically involves recurring episodes of severe headaches and other symptoms. Migraine episodes may occur with auras. These are sensory disturbances, such as seeing flashes of light.

Tosymra has certain limits of use. For details, see the “Tosymra uses” section below.

Drug details

The active drug in Tosymra is sumatriptan. Tosymra belongs to a class of drugs called serotonin (5-HT) agonists, commonly known as “triptans.”

Tosymra comes as a nasal spray device that contains a liquid solution. The medication is available in one strength: 10 milligrams (mg).

Effectiveness

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

Tosymra is a brand-name drug that contains the active drug sumatriptan. There isn’t a generic substitute for Tosymra. However, Imitrex* is another brand-name version of sumatriptan that also comes as a nasal spray. Imitrex nasal spray is 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.

If you’re interested in taking the generic drug sumatriptan, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

* To learn how Tosymra and Imitrex compare, see the “Frequently asked questions” section below.

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

For more information about the possible side effects of Tosymra, 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 Tosymra, you can do so through MedWatch.

Mild side effects

Mild side effects* of Tosymra can include:

  • unusual taste in your mouth
  • sore throat
  • dizziness
  • drowsiness
  • muscle pain or weakness
  • neck stiffness or discomfort
  • tightness in your head, jaw, or chest
  • unusual sensations in and around your nose and throat, such as numbness, tingling, or burning
  • mild allergic reaction

Most of these side effects may go away within a few days to a couple of weeks. 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 Tosymra. To learn about other mild side effects, talk with your doctor or pharmacist, or view Tosymra’s prescribing information.
† For more information about this side effect, see “Allergic reaction” below.

Serious side effects

Serious side effects from Tosymra 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:

  • Blood vessel spasms, which may lead to Prinzmetal angina (a type of chest pain), heart attack, or stroke. Symptoms can vary but generally include:
    • chest pain or tightness
    • pain that may radiate to the head, shoulder, or arm
    • sudden numbness or weakness, especially on one side of the body
    • confusion
    • vision changes
  • Medication overuse headaches (headaches due to taking too much of a medication).* Symptoms can include:
    • migraine-like headaches that may occur every day
  • Serotonin syndrome (very high level of the chemical serotonin). Symptoms can include:
    • agitation (feeling restless or annoyed for no known reason)
    • sweating more than usual
    • nausea, vomiting, or diarrhea
    • rapid heart rate
    • hallucinations (seeing or hearing things that aren’t there)
  • Increased blood pressure, which typically doesn’t cause symptoms. Very high blood pressure may cause:
  • Severe allergic reaction.†

* To learn more, see the “Tosymra withdrawal and dependence” section below.
† For more information about this side effect, see “Allergic reaction” below.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Tosymra. Allergic reactions weren’t reported in Tosymra’s clinical trials. However, allergic reactions have occurred in some people who took other forms of sumatriptan (the active drug in Tosymra).

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 Tosymra, 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.

As with all medications, the cost of Tosymra nasal spray can vary. 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 Tosymra. 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 Tosymra, 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 whether you’ll need to get prior authorization for Tosymra, contact your insurance company.

Financial and insurance assistance

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

Tosymra has a program called Access Pathways. For more information and to find out if you’re eligible for support, call 844-976-3109 or visit the drug website.

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

Mail-order pharmacies

Tosymra 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 Tosymra, 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. The drug’s manufacturer may also be able to connect you with a mail-order pharmacy.

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

Generic version

Tosymra is a brand-name drug that contains the active drug sumatriptan. Currently, there isn’t a generic substitute for Tosymra. However, Imitrex* is another brand-name version of sumatriptan that also comes as a nasal spray. Imitrex nasal spray is available as a generic medication.

A generic drug is an exact copy of the active drug in a brand-name medication. And it is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic drug sumatriptan, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition. You’ll also need to check your insurance plan, as it may only cover one or the other.

* To learn how Tosymra and Imitrex compare, see the “Frequently asked questions” section below.

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

Tosymra for migraine

The FDA has approved Tosymra to treat migraine episodes that occur with or without aura in adults.

Tosymra has some limits of use. The drug is prescribed only to people who have been diagnosed with migraine. Tosymra is not approved to help prevent migraine or treat cluster headaches.

Migraine explained

Migraine is a neurological condition that causes episodes of severe headaches. (The term “neurological” refers to the nervous system.) Migraine episodes are thought to be caused by swollen blood vessels in the head. These swollen blood vessels may cause severe pain and other symptoms.

Other symptoms that commonly occur during migraine episodes can include:

Migraine may occur with or without aura. Auras are sensory disturbances that happen before or during a migraine episode. Auras commonly include changes in vision, such as seeing sparks or flashes of light.

How often migraine episodes occur, as well as their symptoms, severity, and triggers can vary from person to person. Examples of common triggers are lack of sleep, stress, and drinking red wine.

To learn more about managing this condition, see our hub for headache and migraine.

Effectiveness for migraine

Tosymra is an acute (fast-acting) treatment meant to stop a migraine episode that’s already started. Sumatriptan, the active drug in Tosymra, has been shown to be effective in treating migraine episodes.

Tosymra is a nasal spray medication. Nasal sprays can be especially helpful for people who have migraine episodes with nausea and vomiting. These symptoms can make it difficult to keep down oral migraine medications.

To learn how Tosymra performed in clinical trials, see the drug website or Tosymra’s prescribing information.

Tosymra and children

Tosymra is not FDA-approved for use in children. In clinical trials, sumatriptan (the active drug in Tosymra) was not effective for treating migraine in children. Also in these trials, side effects occurred more often in children than in adults.

You can talk with your child’s doctor to learn about migraine treatment options that are suitable for children.

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

Tosymra comes as a nasal spray device that contains a liquid solution. The drug comes in a package that includes six nasal spray devices. Each device contains one dose. You’ll discard the device after use.*

Tosymra is available in one strength: 10 milligrams (mg).

* For more about disposal, see the “Tosymra expiration, storage, and disposal” section below.

Dosage for migraine

Tosymra nasal spray is approved to treat migraine episodes that occur with or without aura in adults.

You use Tosymra after a migraine episode has started. The typical dosage is one spray (10 mg) into one nostril.

If your migraine doesn’t go away or if it comes back, you can take a second dose at least 1 hour after your first dose. If needed, you can take a third dose at least 1 hour after the second dose. You should not take more than 30 mg (three sprays total) of Tosymra in a 24-hour period.

If your migraine doesn’t improve at all after the first dose, talk with your doctor before taking additional doses of Tosymra.

In some cases, doctors may prescribe Tosymra in combination with another medication that contains sumatriptan (the active drug in Tosymra). If you already took sumatriptan and still have migraine symptoms, wait at least 1 hour before you take a dose of Tosymra.

Will I need to use this drug long term?

Tosymra is typically a long-term treatment. However, it isn’t used on a regular basis. Instead, you’ll use Tosymra only as needed for a migraine episode. If you and your doctor determine that Tosymra is safe and effective for you, you’ll likely use it long term, but only when necessary.

You should use Tosymra according to the instructions your doctor gives you.

Tosymra comes as a nasal spray. You’ll spray one dose of the drug into one nostril.

To use Tosymra, follow the guide included in the drug’s packaging. An instructional video is also available on the drug website.

It’s important to note that Tosymra comes in a nasal spray device that contains a single dose of the drug. You should not “prime” or “test” the device before using the medication. If you do, that will waste the dose.

When to use

Be sure to take Tosymra as soon as possible after a migraine episode has started. (The drug is not meant to help prevent migraine headaches.)

Because migraine episodes can begin at any time, consider carrying Tosymra with you.

Also, it’s a good idea to note the date and time of each dose. This is important because you should separate Tosymra doses by at least 1 hour. And you should not take more than 30 milligrams (mg), a total of three sprays, within a 24-hour period. To keep track, try writing down when you have a dose.

Another reason to keep a record of your doses is to help avoid medication overuse headaches. These are headaches that can occur when acute (fast-acting) migraine medications are used 10 or more days per month.

If you have questions about using Tosymra, talk with your doctor or pharmacist.

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.

Taking Tosymra with food

Tosymra is a nasal spray medication. You may use it without regard to the timing of food.

Other drugs are available that can treat migraine headaches. Some may be a better fit for you than others. If you’re interested in finding an alternative to Tosymra, 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’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for migraine

Other drugs that contain sumatriptan (the active drug in Tosymra) are also used to treat migraine. Examples of these medications and their forms include:

  • Imitrex, which is available as a nasal spray, oral tablet, and injection
  • Zembrace SymTouch injection
  • Onzetra Xsail nasal powder

Examples of other drugs used to treat migraine include:

Here are answers to some frequently asked questions about Tosymra.

How does Tosymra compare with Imitrex nasal spray?

Tosymra and Imitrex nasal spray are similar medications. Here are a few key ways they are alike and different:

  • Tosymra and Imitrex nasal sprays contain the same active drug: sumatriptan. However, these medications are prescribed with different dosing instructions.
  • Tosymra is available in one strength of 10 milligrams (mg). Imitrex nasal spray is available in strengths of 5 mg and 20 mg.
  • Imitrex nasal spray has a generic version available. Tosymra currently does not.

In addition, Tosymra is meant to work faster than Imitrex nasal spray.

You can talk with your doctor or pharmacist for more information about how these drugs compare.

Can I use both Tosymra and a nasal spray for allergies?

Yes. Tosymra should not interact with allergy nasal spray medications.

However, it’s generally better to avoid using one nasal spray drug immediately before or after another nasal spray drug. If you use two nasal sprays soon after each other, it could cause the second medication to not be fully absorbed. This is because some of it may drip from your nose. Back-to-back nasal spray use may also worsen any side effects the drugs share, such as throat irritation.

If possible, wait until you’ve finished treating your current migraine episode before using your allergy nasal spray. Your doctor and pharmacist can help answer additional questions you may have.

Why should I track migraine and when I use Tosymra?

Keeping track of migraine can help you and your doctor make informed decisions about treatment options.

Consider using a journal or a migraine app to record the following information:

  • the date and time of any migraine episodes, including symptoms and their severity
  • any medications you took, noting the drug names and doses
  • when you noticed your symptoms ease
  • how long it took for the migraine episode to go away
  • any other related information, such as suspected triggers

Sharing and reviewing this record with your doctor can help determine if Tosymra is working effectively. This information can also help them determine the right treatment plan for you. For example, if you have frequent migraine episodes, your doctor may prescribe a medication that’s meant to help prevent migraine headaches.

In addition, tracking your Tosymra treatment may help you avoid taking doses too often. This is important because too much Tosymra may lead to medication overuse headaches.* These are headaches that can occur when acute (fast-acting) migraine medications are used 10 or more days per month.

If you have questions about migraine trackers, ask your doctor or pharmacist.

* To learn more, see the “Tosymra withdrawal and dependence” section below.

There are no known interactions between Tosymra and alcohol.

However, drinking alcohol may cause some of the same side effects as Tosymra, such as drowsiness. Alcohol may also cause some of the same symptoms as migraine, such as nausea and vomiting. This means that if you consume alcohol while trying to treat migraine, you could feel worse instead of better.

Also, drinking alcohol can trigger migraine headaches in some people. For example, red wine is a common trigger.

If you drink alcohol, ask your doctor for more information. They can tell you how much, if any, is safe for you to consume during Tosymra treatment.

Tosymra 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 side effects or make them more severe.

Tosymra and other medications

Below is a list of medications that can interact with Tosymra. This list does not contain all drugs that may interact with Tosymra.

Before taking Tosymra, 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.

Other acute migraine medication. Tosymra is a type of acute migraine drug. (“Acute” refers to medications that work quickly to ease or stop migraine symptoms.) Drugs called triptans (such as Tosymra) and ergotamines are kinds of acute migraine medications.

Taking another acute migraine drug too close to a dose of Tosymra may increase your risk of serious side effects of both medications. Because of this, you should not take Tosymra if you’ve taken another triptan or migraine medication that contains ergotamine within the past 24 hours. Examples of these drugs include:

  • eletriptan (Relpax)
  • frovatriptan (Frova)
  • naratriptan (Amerge)
  • rizatriptan (Maxalt, Maxalt-MLT)
  • zolmitriptan (Zomig, Zomig-ZMT)
  • dihydroergotamine (Migranal, Trudhesa)
  • ergotamine (Ergostat)

Monoamine oxidase inhibitors. If you’ve taken certain monoamine oxidase inhibitors (MAOIs) within the past 2 weeks, your doctor will likely not prescribe Tosymra. Taking these drugs too close together may increase the risk of serious side effects of Tosymra. The side effects include hypertensive crisis (very high blood pressure) and serotonin syndrome (a very high level of the chemical serotonin). Examples of MAOIs include:

  • isocarboxazid
  • linezolid (Zyvox)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)

Drugs that raise serotonin levels. Taking other drugs that raise serotonin levels may increase the risk of serotonin syndrome with Tosymra. Examples of these drugs include:

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Tosymra and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Tosymra. However, you should still check with your doctor or pharmacist before using any of these products while taking Tosymra.

Tosymra and foods

There aren’t any foods that have been specifically reported to interact with Tosymra. If you have any questions about eating certain foods with Tosymra, talk with your doctor.

Tosymra is prescribed to treat migraine episodes that occur with or without aura in adults. Migraine episodes are thought to be caused by swollen blood vessels in the head. It’s also believed that the body releases certain chemicals that increase inflammation. These effects lead to severe headaches and other migraine symptoms.

Tosymra belongs to a class of drugs called serotonin (5-HT) agonists, commonly known as “triptans.” They activate serotonin, a chemical that acts as a messenger in your brain.

Serotonin attaches to sites called receptors that are on blood vessels in the brain. When serotonin does this, it tells the vessels to constrict (narrow). Drugs called triptans, including Tosymra, also bind to these serotonin receptors, causing the blood vessels to constrict. The drug is also thought to block the release of chemicals that increase inflammation.

How long does it take to work?

Tosymra begins to work right away. In clinical trials, some people noticed migraine symptoms ease within 10 minutes of taking the drug. Most people were symptom-free within 1 to 2 hours.

It’s not known for sure if Tosymra is safe to use during pregnancy.

Animal studies found that fetal development problems occurred when sumatriptan (the active drug in Tosymra) was given to pregnant animals. However, animal studies don’t always predict what could happen in humans.

Information was collected from 1996 to 2012 about the pregnancy outcomes of people who took sumatriptan during pregnancy. The data collected did not show an increased risk of congenital anomalies (commonly known as birth defects) with sumatriptan use.

Additional research has not found an increased risk of pregnancy problems or congenital anomalies with sumatriptan use during pregnancy. However, clinical trials have not been conducted in pregnant people to confirm this finding.

If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of Tosymra before starting treatment.

It’s not known if Tosymra is safe to take during pregnancy. If you or your partner can become pregnant, talk with your doctor about your birth control needs with Tosymra.

For more information about Tosymra and pregnancy, see the “Tosymra and pregnancy” section above.

It’s not known for sure if Tosymra is safe to use while breastfeeding.

Sumatriptan (the active drug in Tosymra) is known to pass into breast milk for 12 hours after treatment with Tosymra. Because of this, your doctor may recommend that you avoid breastfeeding for 12 hours after a dose of the medication. Doing so may minimize a breastfed child’s exposure to Tosymra.

If you’re breastfeeding or considering it, talk with your doctor. They can help determine how you can feed your child and treat migraine episodes.

Tosymra is not safe for everyone. Due to the risk of harm, doctors typically will not prescribe Tosymra to people with certain conditions or factors that affect blood circulation. This is because Tosymra could make these conditions more severe. These are known as contraindications with the drug, and they include:

In addition, Tosymra comes with several precautions. Before taking Tosymra, talk with your doctor about your health history. If you have certain factors or conditions, they’ll monitor you closely if they prescribe Tosymra. These include:

  • Risk factors for heart disease. Before prescribing Tosymra, your doctor may check you for heart disease. They may do this if you have multiple factors that increase the risk of heart problems. These factors include older age, obesity or overweight, smoking, diabetes, high cholesterol, and a family history of heart disease. Your doctor can help determine whether it’s safe for you to try Tosymra. In fact, they may have you take your first dose in their office while they monitor your heart with an EKG.
  • High blood pressure. Tosymra may cause a temporary increase in blood pressure. This may occur even if you already take blood pressure medication. Doctors may not prescribe Tosymra if you already have high blood pressure that isn’t well-managed. Or they may have you monitor your blood pressure closely after taking Tosymra.
  • Seizures. Tosymra may increase the risk of seizures. If you have epilepsy or other factors that may cause seizures, this medication may further increase this risk. Be sure to talk with your doctor about this before starting Tosymra treatment. They’ll help determine if it’s safe for you to try the drug.
  • Allergic reaction. If you’ve had an allergic reaction to Tosymra or any of its ingredients, your doctor will likely not prescribe this drug. Ask your doctor about other medications that may be better options for you.
  • Pregnancy. It’s not known whether Tosymra is safe to use during pregnancy. For more information, see the “Tosymra and pregnancy” section above.
  • Breastfeeding. It’s not known whether Tosymra is safe to take while breastfeeding. For more information, see the “Tosymra and breastfeeding” section above.

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

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

Overdose symptoms

A heart problem called coronary vasospasm occurred with an overdose of sumatriptan injection. (Sumatriptan is the active drug in Tosymra.) Based on animal studies, symptoms of an overdose of sumatriptan injection may include:

  • convulsions
  • tremor
  • redness or discoloration of hands or feet
  • slowed breathing rate
  • blue or gray discoloration of the skin due to poor circulation
  • trouble with coordinated movements, such as walking
  • dilated pupils
  • paralysis (inability to move your muscles)
  • injection site reactions,* such as skin peeling, hair loss, or scabbing

* Tosymra is a nasal spray, so injection site reactions would not occur with the drug.

What to do in case of overdose

If you think you’ve used 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. If your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Tosymra does not cause drug dependence (needing a drug to function as usual). And stopping Tosymra treatment should not cause drug withdrawal. With withdrawal, unpleasant symptoms occur when you stop taking a drug your body has become dependent on.

Tosymra is not a medication that you take on a regular basis. You’ll take it only as needed for a migraine episode that’s already started.

Keep in mind that using too much Tosymra may lead to medication overuse headaches. These are headaches that can happen when acute (fast-acting) migraine medications are taken 10 or more days per month. Medication overuse headaches differ from migraine headaches in that they may occur every day or more often than usual.

The headaches may briefly worsen if you stop using Tosymra. So if you have medication overuse headaches, talk with your doctor. They can guide you on slowly reducing the amount of Tosymra you use.

To help prevent rebound headaches, keep track of when you use Tosymra as well as any other headache-relieving medications. Then share this information with your doctor. Knowing the frequency of your migraine episodes can help your doctor determine the right treatment plan. For example, they may recommend a medication to help prevent migraine headaches.

When you get Tosymra 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.

You should store Tosymra at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container. If necessary, you can temporarily keep the medication at higher or lower temperatures: 59°F to 86°F (15°C to 30°C).

You should not refrigerate or freeze Tosymra. Also, avoid storing it in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Tosymra 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.