Frovatriptan Side Effects

Some side effects of frovatriptan 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 frovatriptan: oral tablet

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

Stop using frovatriptan 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 frovatriptan may include:

• mild headache (not a migraine);

• feeling too warm or too cold;

• dry mouth, upset stomach;

• bone or joint pain;

• 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.

For Healthcare Professionals

Applies to frovatriptan: oral tablet

Cardiovascular

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.

Cardiovascular side effects reported with the use of frovatriptan have included palpitation (>1% of patients) and less frequently, tachycardia, abnormal electrocardiogram (ECG), and bradycardia.

Nervous system

Nervous system side effects reported during clinical trials included dizziness (8% vs. 5% placebo), headache (4% vs. 3% placebo), and paresthesia (4% vs. 2% placebo). Additional nervous system side effects reported with the use of frovatriptan have included infrequent cases of tremor, hyperesthesia, worsened migraine, involuntary muscle contractions, vertigo, ataxia, somnolence, abnormal gait and speech disorder. Hypertonia, hypotonia, syncope, abnormal reflexes and tongue paralysis were rarely reported during clinical trials involving frovatriptan. There have also been postmarketing reports of seizure in close temporal association with triptan use.

General

General side effects reported as frequent with the use of frovatriptan have included pain, fatigue, hot or cold sensation, and chest pain. Other general side effects reported less frequently have included asthenia, rigors, fever, hot flushes and malaise. Rarely reported general side effects of frovatriptan use have included feelings of relaxation, leg pain and mouth edema.

Gastrointestinal

Gastrointestinal side effects reported most often during clinical trials included dry mouth (3% vs. 1% placebo) and dyspepsia (2% vs. 1% placebo). Additional gastrointestinal side effects reported as frequent during clinical trials of frovatriptan have included vomiting, nausea, abdominal pain, and diarrhea. Infrequently reported gastrointestinal side effects have included dysphagia, flatulence, constipation, anorexia, esophagospasm, and increased salivation. Rarely reported gastrointestinal side effects have included a change in bowel habits, chelitis, eructation, gastroesophageal reflux, hiccough, peptic ulcer, salivary gland pain, stomatitis, and toothache.

Psychiatric

Psychiatric side effects reported as having occurred frequently during clinical trials involving frovatriptan have included insomnia and anxiety. Reported as infrequent psychiatric side effects were confusion, nervousness, agitation, euphoria, impaired concentration, depression, emotional lability, amnesia, thinking abnormally, and depersonalization. Reports of aggravated depression, abnormal dreaming, and personality disorder have rarely occurred.

Musculoskeletal

Musculoskeletal side effects reported as having occurred frequently during clinical trials have included skeletal pain (3% vs. 2% placebo). Additional musculoskeletal side effects having occurred infrequently with the use of frovatriptan have included myalgia, back pain, arthralgia, arthrosis, leg cramps, and muscle weakness.

Respiratory

Respiratory side effects reported as having occurred frequently during clinical trials of frovatriptan have included sinusitis and rhinitis. Additional respiratory side effects have included infrequent reports of pharyngitis, dyspnea, hyperventilation and laryngitis.

Ocular

Ocular side effects reported as having occurred frequently during clinical trials involving frovatriptan have included abnormal vision. Infrequently reported ocular side effects have included eye pain, conjunctivitis, and abnormal lacrimation.

Dermatologic

Dermatologic side effects reported as having occurred frequently during clinical trials involving frovatriptan have included increased sweating. Infrequently reported dermatologic side effects have included pruritus and bullous eruption.

Other

Other side effects reported as having occurred frequently during clinical trials involving frovatriptan have included tinnitus. Infrequently reported other side effects have included earache, hyperacusis, and taste perversion.

Genitourinary

Genitourinary side effects have been reported infrequently with the use of frovatriptan and have included increased micturition frequency and polyuria. Additionally, rare reports of nocturia, renal pain, and abnormal urine have occurred.

Metabolic

Metabolic side effects have been reported infrequently with the use of frovatriptan and have included increased thirst and dehydration. Additionally, rare reports of hypocalcemia and hypoglycemia have occurred.

Hematologic

Hematologic side effects have been reported infrequently with the use of frovatriptan and have included epistaxis. Additionally, rare reports of purpura have occurred.

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