Almotriptan Side Effects

Some side effects of almotriptan 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 almotriptan: oral tablet

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

Stop using almotriptan 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, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects of almotriptan may include:

• dry mouth, nausea, vomiting;

• pressure or heavy feeling in any part of your body;

• mild headache (not a migraine);

• dizziness, drowsiness; 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 almotriptan: oral tablet

Cardiovascular

In one study (n=20), significant effects were reported for the maximal change in diastolic blood pressure and for the maximal and mean change in systolic blood pressure.

Cardiovascular side effects, some fatal, have occurred following the use of 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Such effects include coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. Less frequently reported cardiovascular side effects have included vasodilation, palpitations, and tachycardia. Hypertension and syncope have been rarely reported.

General

General side effects have included headache, abdominal pain or cramp, asthenia, chills, back pain, chest pain, neck pain, fatigue, and rigid neck. Fever and photosensitivity reaction have been rarely reported. Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw have been reported after treatment with almotriptan. (These events were not associated with arrhythmias or ischemic ECG changes in clinical trials.)

Gastrointestinal

Gastrointestinal side effects including nausea and dry mouth have been frequently reported. Less frequently reported gastrointestinal side effects have included diarrhea, vomiting, and dyspepsia. Colitis, gastritis, gastroenteritis, esophageal reflux, increased thirst, and increased salivation have been rarely reported.

Metabolic

Metabolic side effects reported infrequently have included hyperglycemia and increased serum creatine phosphokinase. Increased gamma glutamyltransferase and hypercholesterolemia have been rarely reported.

Musculoskeletal

Musculoskeletal side effects have included myalgia and muscular weakness. Arthralgia, arthritis, and myopathy have been rarely reported.

Nervous system

Nervous system side effects frequently reported have included paraesthesia, dizziness, and somnolence. Less frequently reported nervous system side effects have included tremor, vertigo, anxiety, hyperesthesia, restlessness, CNS stimulation, insomnia, and shakiness. Altered dreams, impaired concentration, abnormal coordination, depressive symptoms, euphoria, hyperreflexia, hypertonia, nervousness, neuropathy, nightmares, and nystagmus have been rarely reported.

Respiratory

Respiratory side effects including pharyngitis, rhinitis, dyspnea, laryngismus, sinusitis, bronchitis, and epistaxis have been reported infrequently. Hyperventilation, laryngitis, and sneezing have been reported rarely.

Dermatologic

Dermatologic side effects including diaphoresis, dermatitis, erythema, pruritus, and rash have been infrequently reported.

Other

Special sense reactions have included ear pain, conjunctivitis, eye irritation, hyperacusis, and taste alteration. Diplopia, dry eyes, eye pain, otitis media, parosmia, scotoma, and tinnitus have been rarely reported.

Genitourinary

Genitourinary side effects reported infrequently have included dysmenorrhea.

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