Frovatriptan Side Effects

Brand Names: Frova

Please note - some side effects for Frovatriptan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Frovatriptan - for the Consumer

Frovatriptan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Frovatriptan:

Dizziness; drowsiness; dry mouth; fatigue; flushing; headache; hot or cold sensations; indigestion; numbness or tingling in the arms, legs, hands, or feet.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bone or joint pain; confusion, slurred speech, or changes in vision; hallucinations; irregular or rapid heartbeat; loss of coordination; mental or mood changes (eg, agitation); muscle spasms; one-sided weakness; pain or unusual coldness in feet, legs, hands, or arms; pain, tightness, pressure, and heaviness in the chest, throat, neck, or jaw; pale or blue-colored fingers or toes; persistent numbness or tingling in the arms, legs, hands, or feet; seizures; severe stomach pain; sudden severe dizziness, fainting, headache, or vomiting; sudden shortness of breath.

Side Effects by Body System

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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