Imitrex Side Effects

Generic name: sumatriptan

Note: This document contains side effect information about sumatriptan. Some of the dosage forms listed on this page may not apply to the brand name Imitrex.

Some side effects of Imitrex 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 sumatriptan: nasal spray, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sumatriptan (the active ingredient contained in Imitrex) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sumatriptan and call your doctor 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;

• seizure (convulsions);

• 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 sumatriptan may include:

• mild headache (not a migraine);

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

• feeling hot or cold;

• dizziness, spinning sensation;

• drowsiness;

• nausea, vomiting, drooling;

• unusual taste in your mouth after using the nasal spray;

• burning, numbness, pain or other irritation in your nose or throat after using the nasal spray; 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 sumatriptan: nasal spray, oral tablet, subcutaneous kit, subcutaneous solution

Other

The manufacturer (GlaxoSmithKline Inc.) encourages clinicians to report suspected adverse events to its Product Surveillance Department (1-800-334-4153).

Cardiovascular

Sumatriptan is contraindicated in patients with coronary artery disease.

Chest discomfort is usually noncardiac in origin. A survey of 453 migraine patients found chest symptoms occurred in up to 58% of patients in at least some attacks and in up to 42% of patients in all attacks.

One study of 735 consecutive migraine patients reported that chest symptoms are frequent, but rarely important adverse effects of (primarily subcutaneous) sumatriptan (the active ingredient contained in Imitrex) The risk of chest symptoms was patient-dependent and not related, even opposite, to cardiovascular disease. This report contradicts the hypothesis that chest symptoms after sumatriptan are caused by cardiac ischemia.

Another study of 125 patients concluded that panic-like symptoms may explain the chest pain and related side effects after sumatriptan administration in patients with high levels of anxiety.

Cardiovascular side effects including serious, sometimes fatal cardiac events such as ventricular fibrillation, transient myocardial ischemia, ventricular tachycardia, and coronary artery vasospasm sometimes resulting in myocardial infarction have been reported following the administration of sumatriptan injection. Serious and/or life threatening arrhythmias including atrial fibrillation, ventricular fibrillation, ventricular tachycardia, myocardial infarction, ECG changes suggestive of myocardial ischemia and symptoms consistent with angina pectoris have been reported after administration of oral sumatriptan. Cardiomyopathy, colonic ischemia, Prinzmetal variant angina, thrombophlebitis, angioedema, cerebrovascular accident, pulmonary embolism, shock, subarachnoid hemorrhage, hypertension, bradycardia, and precordial distress have also been reported. In addition, nonspecific EKG changes including ST and T wave changes, prolongation of the PR and QTc intervals, ectopy, and syncope have been reported.

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, pancytopenia, and cyanosis have been reported.

General

One report has suggested that "throat tightness" and chest pain associated with sumatriptan (the active ingredient contained in Imitrex) may sometimes be attributable to changes in esophageal motility.

General side effects including atypical sensations such as tingling, warm or hot sensations, flushing, feeling of tightness, neck stiffness, feeling of heaviness, and other sensations have been reported frequently.

Hypersensitivity

Hypersensitivity side effects including rash, urticaria, pruritus, erythema, and shortness of breath have been reported. Life threatening and fatal anaphylaxis/anaphylactoid reactions have been reported rarely.

Local

Local side effects including reactions at the site of subcutaneous injection have been reported and have included lipoatrophy, lipohypertrophy, pain, burning, swelling, and redness.

Hepatic

Hepatic side effects including disturbances of liver function tests and hepatic impairment have been reported.

Renal

Renal side effects including acute renal failure and angioneurotic edema have been reported.

Ocular

Visual disorders may also be a part of a migraine attack.

Ocular side effects including loss of vision, vision alterations, intraocular disorders, ischemic optic neuropathy, periorbital edema, temporal arteritis, retinal vein thrombosis, and retinal artery occlusion have been reported. Both significant partial vision loss and transient or permanent blindness have been reported very rarely.

Nervous system

One case of sumatriptan-induced cortical stroke has been reported in a patient with sagittal sinus thrombosis.

Sumatriptan (the active ingredient contained in Imitrex) should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Nervous system side effects including anxiety have been reported frequently. Paresthesias, dizziness, and headache have also been reported. Seizures and strokes have rarely been reported. Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, and subarachnoid hemorrhage have been part of postmarketing events which have been reported. Five cases of akathisia including one together with acute oral dystonia have been reported. Cases of intracranial hemorrhages as well as transient hemiplegia and hemiparesis have also been reported.

Gastrointestinal

Gastrointestinal side effects including abdominal discomfort, dysphagia, nausea, vomiting, ischemic colitis with rectal bleeding, xerostomia, and diarrhea have been reported. Two cases have been reported by Mayo Clinic researchers documenting the association between use of sumatriptan (the active ingredient contained in Imitrex) and mesenteric ischemia (a condition characterized by acute cramping, abdominal pain, and bloody diarrhea).

Patients receiving sumatriptan should discontinue the use of the medication and consult with their physician immediately if they experience abdominal pain with bloody diarrhea.

Endocrine

Endocrine side effects have been suggested in one study which reported that sumatriptan (the active ingredient contained in Imitrex) may increase the secretion of growth hormone by the anterior pituitary.

Dermatologic

Dermatologic side effects including exacerbation of sunburn and photosensitivity have been reported.

Other

Other side effects including dysphasia, xerostomia, angioneurotic edema, cyanosis, temporal arteritis, deafness, and death have been reported.

Musculoskeletal

Musculoskeletal side effects including muscle cramps have been reported frequently.

Genitourinary

Genitourinary side effects including acute renal failure have been reported.

Psychiatric

Psychiatric side effects including panic disorder have been reported.

Respiratory

Respiratory side effects including bronchospasm have been reported.

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