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Relpax

"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...

Relpax

Relpax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Relpax (eletriptan hydrobromide) is used to treat migraine headaches. Relpax will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. Relpax belongs to the selective serotonin receptor agonist drug class. Common side effects include tingling/numbness, nausea, weakness, drowsiness, or dizziness.

A single dose of 20 mg or 40 mg is effective for the acute treatment of migraine in adults. After taking Relpax, you must wait 2 hours before taking another dose. Relpax should not be used with sibutramine because a very serious interaction may occur. Relpax should not be used within 72 hours of use of drugs affecting liver enzymes that remove eletriptan from your body such as nefazodone, azole antifungals, antibiotics, and protease inhibitors. Relpax should not be used within 24 hours of use of ergot-type drugs or other migraine drugs because of serious interactions. Antidepressants, St. John's wort, antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, and psychiatric medicines may all adversely interact with this drug. Discuss all medications you are taking with your doctor. During pregnancy, this medication should be used only when prescribed by your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.

Our Relpax 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.

Relpax 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 eletriptan 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 severe 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, high fever, sweating, fast or pounding heartbeats, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting.

Less serious side effects may include:

  • mild headache (not a migraine);
  • pressure or heavy feeling in any part of your body;
  • dry mouth, upset stomach, stomach pain or cramps;
  • dizziness, drowsiness, weakness; 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 Relpax (Eletriptan hydrobromide) »

What is Patient Information Overview?

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

Relpax Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, feelings of tingling/numbness, weakness, tiredness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell 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.

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

Chest/jaw/neck tightness can commonly occur soon after using eletriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due 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 Relpax (Eletriptan hydrobromide)»

What is Prescribing information?

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

Relpax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described elsewhere in other sections of the prescribing information:

Clinical Trials Experience

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

Among 4,597 patients who treated the first migraine headache with RELPAX in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with RELPAX were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related.

In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions.

Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials.

Only adverse reactions that were more frequent in a RELPAX treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table 1.

Table 1: Adverse Reactions Incidence in Placebo-Controlled Migraine Clinical Trials: Reactions Reported by ≥ 2% Patients Treated with RELPAX and More Than Placebo

Adverse Reaction Type Placebo
(n=988)
RELPAX 20 mg
(n=431)
RELPAX 40 mg
(n=1774)
RELPAX 80 mg
(n=1932)
ATYPICAL SENSATIONS
Paresthesia 2% 3% 3% 4%
Flushing/feeling of warmth 2% 2% 2% 2%
PAIN AND PRESSURE SENSATIONS
Chest - tightness/pain/pressure 1% 1% 2% 4%
Abdominal - pain/discomfort/stomach pain/ cramps/pressure 1% 1% 2% 2%
DIGESTIVE
Dry mouth 2% 2% 3% 4%
Dyspepsia 1% 1% 2% 2%
Dysphagia - throat tightness/difficulty swallowing 0.20% 1% 2% 2%
Nausea 5% 4% 5% 8%
NEUROLOGICAL
Dizziness 3% 3% 6% 7%
Somnolence 4% 3% 6% 7%
Headache 3% 4% 3% 4%
OTHER
Asthenia 3% 4% 5% 10%

The frequency of adverse reactions in clinical trials did not increase when up to 2 doses of RELPAX were taken within 24 hours. The incidence of adverse reactions in controlled clinical trials was not affected by gender, age, or race of the patients. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (e.g., SSRIs, beta blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy or oral contraceptives.

Postmarketing Experience

The following adverse reaction(s) have been identified during post approval use of RELPAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Neurological: seizure

Digestive: vomiting

Read the entire FDA prescribing information for Relpax (Eletriptan hydrobromide) »

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Relpax - User Reviews

Relpax 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 Relpax 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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