Imitrex Side Effects

Generic Name: sumatriptan

Please note - some side effects for Imitrex 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 Imitrex - for the Consumer

Imitrex

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 Imitrex:

Burning, numbness, or tingling of the skin; dizziness; drowsiness; feeling of heaviness, pressure, or tightness; feeling strange; mild, temporary flushing; muscle aches; nausea; neck stiffness; pain, swelling, or redness at the injection site; sick feeling; throat or sinus discomfort; tight feeling in the head; tingling; tiredness; vomiting; warm/hot sensation; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; fever; hallucinations; hearing problems; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; seizures; severe headache, dizziness, or vomiting; severe or prolonged flushing; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of vision; wheezing.

Imitrex Spray

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 Imitrex Spray:

Bad or unusual taste; burning, numbness, tingling, discharge, pain, or soreness of the nose, throat, or sinuses; dizziness; drowsiness; feeling of heaviness or pressure; mild, temporary flushing; nausea; sick feeling; tingling; tiredness; vomiting; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; fever; hallucinations; hearing problems; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; seizures; severe headache, dizziness, or vomiting; severe or prolonged flushing; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of vision; wheezing.

Imitrex Tablets

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 Imitrex Tablets:

Burning; dizziness; drowsiness; feeling of heaviness or pressure; muscle aches; numbness or tingling of the skin; sick feeling; tingling; tiredness; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; fever; hallucination; hearing problems; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; seizures; severe headache, dizziness, or vomiting; severe or prolonged flushing; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of vision; wheezing.

Imitrex Side Effects - for the Professional

Imitrex

Serious cardiac events, including some that have been fatal, have occurred following the use of Imitrex Injection or Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.

Significant hypertensive episodes, including hypertensive crises, have been reported on rare occasions in patients with or without a history of hypertension.

Incidence in Controlled Clinical Trials

Table 2 lists adverse events that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only events that occurred at a frequency of 2% or more in any group treated with Imitrex Tablets and were more frequent in that group than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

*Events that occurred at a frequency of 2% or more in the group treated with Imitrex Tablets and that occurred more frequently in that group than the placebo group.

Other events that occurred in more than 1% of patients receiving Imitrex Tablets and at least as often on placebo included nausea and/or vomiting, migraine, headache, hyposalivation, dizziness, and drowsiness/sleepiness.

Imitrex Tablets are generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.

Other Events Observed in Association With the Administration of Imitrex Tablets

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of Imitrex Tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Imitrex Tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to Imitrex Tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Frequent were burning sensation and numbness. Infrequent was tight feeling in head. Rare were dysesthesia.

Frequent were palpitations, syncope, decreased blood pressure, and increased blood pressure. Infrequent were arrhythmia, changes in ECG, hypertension, hypotension, pallor, pulsating sensations, and tachycardia. Rare were angina, atherosclerosis, bradycardia, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, thrombosis, transient myocardial ischemia, and vasodilation.

Frequent were sinusitis, tinnitus; allergic rhinitis; upper respiratory inflammation; ear, nose, and throat hemorrhage; external otitis; hearing loss; nasal inflammation; and sensitivity to noise. Infrequent were hearing disturbances and otalgia. Rare was feeling of fullness in the ear(s).

Infrequent was thirst. Rare were elevated thyrotropin stimulating hormone (TSH) levels; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; polydipsia; weight gain; weight loss; endocrine cysts, lumps, and masses; and fluid disturbances.

Rare were disorders of sclera, mydriasis, blindness and low vision, visual disturbances, eye edema and swelling, eye irritation and itching, accommodation disorders, external ocular muscle disorders, eye hemorrhage, eye pain, and keratitis and conjunctivitis.

Frequent were diarrhea and gastric symptoms. Infrequent were constipation, dysphagia, and gastroesophageal reflux. Rare were gastrointestinal bleeding, hematemesis, melena, peptic ulcer, gastrointestinal pain, dyspeptic symptoms, dental pain, feelings of gastrointestinal pressure, gastritis, gastroenteritis, hypersalivation, abdominal distention, oral itching and irritation, salivary gland swelling, and swallowing disorders.

Rare was anemia.

Frequent was myalgia. Infrequent was muscle cramps. Rare were tetany; muscle atrophy, weakness, and tiredness; arthralgia and articular rheumatitis; acquired musculoskeletal deformity; muscle stiffness, tightness, and rigidity; and musculoskeletal inflammation.

Frequent were phonophobia and photophobia. Infrequent were confusion, depression, difficulty concentrating, disturbance of smell, dysarthria, euphoria, facial pain, heat sensitivity, incoordination, lacrimation, monoplegia, sleep disturbance, shivering, syncope, and tremor. Rare were aggressiveness, apathy, bradylogia, cluster headache, convulsions, decreased appetite, drug abuse, dystonic reaction, facial paralysis, hallucinations, hunger, hyperesthesia, hysteria, increased alertness, memory disturbance, neuralgia, paralysis, personality change, phobia, radiculopathy, rigidity, suicide, twitching, agitation, anxiety, depressive disorders, detachment, motor dysfunction, neurotic disorders, psychomotor disorders, taste disturbances, and raised intracranial pressure.

Frequent was dyspnea. Infrequent was asthma. Rare were hiccoughs, breathing disorders, cough, and bronchitis.

Frequent was sweating. Infrequent were erythema, pruritus, rash, and skin tenderness. Rare were dry/scaly skin, tightness of skin, wrinkling of skin, eczema, seborrheic dermatitis, and skin nodules.

Infrequent was tenderness. Rare were nipple discharge; breast swelling; cysts, lumps, and masses of breasts; and primary malignant breast neoplasm.

Infrequent were dysmenorrhea, increased urination, and intermenstrual bleeding. Rare were abortion and hematuria, urinary frequency, bladder inflammation, micturition disorders, urethritis, urinary infections, menstruation symptoms, abnormal menstrual cycle, inflammation of fallopian tubes, and menstrual cycle symptoms.

Frequent was hypersensitivity. Infrequent were fever, fluid retention, and overdose. Rare were edema, hematoma, lymphadenopathy, speech disturbance, voice disturbances, contusions.

Other Events Observed in the Clinical Development of Imitrex

The following adverse events occurred in clinical trials with Imitrex Injection and Imitrex Nasal Spray. Because the reports include events observed in open and uncontrolled studies, the role of Imitrex in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Feeling strange, prickling sensation, tingling, and hot sensation.

Abdominal aortic aneurysm, abnormal pulse, flushing, phlebitis, Raynaud syndrome, and various transient ECG changes (nonspecific ST or T wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle).

Chest discomfort.

Dehydration.

Disorder/discomfort nasal cavity and sinuses, ear infection, Meniere disease, and throat discomfort.

Vision alterations.

Abdominal discomfort, colitis, disturbance of liver function tests, flatulence/eructation, gallstones, intestinal obstruction, pancreatitis, and retching.

Difficulty in walking, hypersensitivity to various agents, jaw discomfort, miscellaneous laboratory abnormalities, “serotonin agonist effect,” swelling of the extremities, and swelling of the face.

Disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).

Arthritis, backache, intervertebral disc disorder, neck pain/stiffness, need to flex calf muscles, and various joint disturbances (pain, stiffness, swelling, ache).

Bad/unusual taste, chills, diplegia, disturbance of emotions, sedation, globus hystericus, intoxication, myoclonia, neoplasm of pituitary, relaxation, sensation of lightness, simultaneous hot and cold sensations, stinging sensations, stress, tickling sensations, transient hemiplegia, and yawning.

Influenza and diseases of the lower respiratory tract and lower respiratory tract infection.

Skin eruption, herpes, and peeling of the skin.

Disorder of breasts, endometriosis, and renal calculus.

Postmarketing Experience (Reports for Subcutaneous or Oral Sumatriptan)

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Hemolytic anemia, pancytopenia, thrombocytopenia.

Atrial fibrillation, cardiomyopathy, colonic ischemia, Prinzmetal variant angina, pulmonary embolism, shock, thrombophlebitis.

Deafness.

Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision.

Ischemic colitis with rectal bleeding, xerostomia.

Elevated liver function tests.

Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage.

Angioneurotic edema, cyanosis, death, temporal arteritis.

Panic disorder.

Bronchospasm in patients with and without a history of asthma.

Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported [see WARNINGS]), photosensitivity.

Acute renal failure.

Side Effects by Body System

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 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

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.

One report has suggested that "throat tightness" and chest pain associated with sumatriptan may sometimes be attributable to changes in esophageal motility.

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

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.

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

Nervous system

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

Sumatriptan 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

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

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 and mesenteric ischemia (a condition characterized by acute cramping, abdominal pain, and bloody diarrhea).

Endocrine

Endocrine side effects have been suggested in one study which reported that sumatriptan 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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