Eletriptan Side Effects

Some side effects of eletriptan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to eletriptan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking eletriptan: 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 of eletriptan 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.

For Healthcare Professionals

Applies to eletriptan: oral tablet

Cardiovascular

Serious cardiac events are extremely rare and most have been reported in patients with risk factors predictive of coronary artery disease.

Serious cardiovascular side effects following the use of 5-HT1 agonists have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. Some of these events have been fatal. Tightness/pain/pressure in the chest (up to 4%) have also been reported. Palpitation has been reported frequently. Hypertension, peripheral vascular disorder, and tachycardia have been reported infrequently. Angina pectoris, arrhythmia, atrial fibrillation, AV block, bradycardia, hypotension, syncope, thrombophlebitis, cerebrovascular disorder, vasospasm, and ventricular arrhythmia have been reported rarely.

Other

Cerebrovascular side effects including hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT1 agonists. Some of these events have resulted in fatalities.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 8%), dry mouth (up to 4%), pain/discomfort/stomach pain/cramps/pressure (up to 2%), dyspepsia (up to 2%), and dysphagia (up to 2%) have been reported. Anorexia, constipation, diarrhea, eructation, esophagitis, flatulence, gastritis, gastrointestinal disorder, glossitis, increased salivation, and liver function test abnormalities have been reported infrequently. Gingivitis, hematemesis, increased appetite, rectal disorder, stomatitis, tongue disorder, tongue edema, and tooth disorder have been reported rarely. Vomiting has been reported during postmarketing use.

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Nervous system

Nervous system side effects including dizziness (up to 7%), somnolence (up to 7%), and headache (up to 4%) have been reported. Hypertonia, hypesthesia, and vertigo have been reported frequently. Abnormal dreams, agitation, anxiety, apathy, ataxia, confusion, depersonalization, depression, emotional lability, euphoria, hyperesthesia, hyperkinesia, incoordination, insomnia, nervousness, speech disorder, stupor, abnormal thinking, and tremor have been reported infrequently. Abnormal gait, amnesia, aphasia, catatonic reaction, dementia, diplopia, dystonia, hallucinations, hemiplegia, hyperalgesia, hypokinesia, hysteria, manic reaction, neuropathy, neurosis, oculogyric crisis, paralysis, psychotic depression, sleep disorder, and twitching have been reported rarely. Postmarketing reports have included seizure.

General

General side effects including asthenia (up to 10%), paresthesia (up to 4%), and a flushing/feeling of warmth (2%) have been reported. Back pain, chills, and pain have been reported frequently. Facial edema and malaise have been reported infrequently. Abdominal enlargement, abscess, accidental injury, fever, flu syndrome, halitosis, hernia, hypothermia, lab test abnormalities, moniliasis, rheumatoid arthritis, and shock have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including allergic reaction have been reported rarely.

Endocrine

Endocrine side effects including goiter, thyroid adenoma, and thyroiditis have been reported rarely.

Hematologic

Hematologic side effects including anemia, cyanosis, leukopenia, lymphadenopathy, monocytosis, and purpura have been reported rarely.

Metabolic

Metabolic side effects including increased creatine phosphokinase, edema, peripheral edema, and thirst have been reported infrequently. Increased alkaline phosphatase bilirubinemia, hyperglycemia, weight gain, and weight loss have been reported rarely.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, arthrosis, bone pain, myalgia, and myasthenia have been reported infrequently. Bone neoplasm, joint disorder, myopathy, and tenosynovitis have been reported rarely.

Respiratory

Respiratory side effects including pharyngitis have been reported frequently. Asthma, dyspnea, respiratory disorder, respiratory tract infection, rhinitis, voice alteration, and yawn have been reported infrequently. Bronchitis, choking sensation, increased cough, epistaxis, hiccup, hyperventilation, laryngitis, sinusitis, and increased sputum have been reported rarely.

Dermatologic

Dermatologic side effects including sweating have been reported frequently. Pruritus, rash, and skin disorder have been reported infrequently. Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, psoriasis, skin discoloration, skin hypertrophy, and urticaria have been reported rarely.

Ocular

Ocular side effects including abnormal vision, conjunctivitis, eye pain, lacrimation disorder, and photophobia have been reported infrequently. Abnormality of accommodation, dry eyes, eye hemorrhage, and ptosis have been reported rarely.

Other

Other side effect affecting the senses including ear pain, taste perversion, and tinnitus have been reported infrequently. Ear disorder, otitis media, and parosmia have been reported rarely.

Genitourinary

Genitourinary side effects including impotence, polyuria, urinary frequency, and urinary tract disorder have been reported infrequently. Breast pain, kidney pain, leukorrhea, menorrhagia, menstrual disorder, and vaginitis have been reported rarely.

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