July 28, 2016
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Amerge

"COPENHAGEN ” An investigational agent that blocks a key headache-related receptor significantly reduces the number of mean monthly migraine days, new phase 2 data show.

Findings showed that after 52 weeks, 18.5% of patients with migra"...

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Amerge




Amerge Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/22/2015

Amerge (naratriptan) is a headache medicine used to treat migraine headaches. Amerge will only treat a headache that has already begun. Amerge will not prevent headaches or reduce the number of attacks. Amerge is available in generic form. Common side effects of Amerge include flushing, sensations of tingling/numbness/prickling/heat/warmth under your skin, weakness, drowsiness, tired feeling, dizziness, or pressure or heavy feeling in any part of your body.

The adult dose of Amerge is 1 mg or 2.5 mg tablets taken with fluid. The dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period. Amerge may interact with other migraine headache medicines, or antidepressants. Tell your doctor all medications you use. Amerge should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Amerge (naratriptan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Amerge in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naratriptan and call your doctor at once if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • pressure or heavy feeling in any part of your body;
  • dizziness, drowsiness, tired feeling; or
  • warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Amerge (Naratriptan)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Amerge Overview - Patient Information: Side Effects

SIDE EFFECTS: Flushing, sensations of tingling/numbness/prickling/heat, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes.

Chest/jaw/neck tightness can commonly occur shortly after using naratriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell this apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Amerge (Naratriptan)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Amerge FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a long-term open-label trial where patients were allowed to treat multiple migraine attacks for up to 1 year, 15 patients (3.6%) discontinued treatment due to adverse reactions.

In controlled clinical trials, the most common adverse reactions were paresthesias, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms, which occurred at a rate of 2% and at least 2 times placebo rate.

Table 1 lists the adverse reactions that occurred in 5 placebo-controlled clinical trials of approximately 1,752 exposures to placebo and AMERGE in adult patients with migraine. Only reactions that occurred at a frequency of 2% or more in groups treated with AMERGE 2.5 mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Table 1.

Table 1: Adverse Reactions Reported by at Least 2% of Patients Treated with AMERGE and at a Frequency Greater than Placebo

Adverse Reaction Percent of Patients Reporting
AMERGE 1 mg
(n = 627)
AMERGE 2.5 mg
(n = 627)
Placebo
(n = 498)
Atypical sensation 2 4 1
  Paresthesias (all types) 1 2 < 1
Gastrointestinal 6 7 5
  Nausea 4 5 4
Neurological 4 7 3
  Dizziness 1 2 1
  Drowsiness  1 2 < 1
  Malaise/fatigue 2 2 1
Pain and pressure sensation 2 4 2
  Throat/neck symptoms 1 2 1

The incidence of adverse reactions in controlled clinical trials was not affected by age or weight of the patients, duration of headache prior to treatment, presence of aura, use of prophylactic medications, or tobacco use. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Read the entire FDA prescribing information for Amerge (Naratriptan)

Amerge - User Reviews

Amerge User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Amerge sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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