Sumatriptan Side Effects

Brand Names: Imitrex

Please note - some side effects for Sumatriptan 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 Sumatriptan - for the consumer

Sumatriptan

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 Sumatriptan:

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.

Sumatriptan/Naproxen

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 Sumatriptan/Naproxen:

Constipation; diarrhea; dizziness; drowsiness; gas; heartburn; mild feeling of heaviness or pressure; mild numbness or tingling of the skin; nausea; stomach upset; tiredness; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bloody or black, tarry stools; change in the amount of urine produced; chest, neck, or jaw pain, tightness, or pressure; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of vision or other vision changes; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe or prolonged flushing; severe vomiting; shortness of breath; slurred speech or other speech changes; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; very cold or blue fingers or toes; vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.

Sumatriptan 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 Sumatriptan 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.

Sumatriptan 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 Sumatriptan 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.

For the professional

Sumatriptan

Serious cardiac events, including some that have been fatal, have occurred following the use of Sumatriptan 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 Sumatriptan succinate 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 Sumatriptan succinate tablets and that occurred more frequently in that group than the placebo group.

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

Sumatriptan succinate 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 Sumatriptan succinate 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 Sumatriptan succinate 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 Sumatriptan succinate tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to Sumatriptan succinate 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.

Atypical Sensations

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

Cardiovascular

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.

Ear, Nose, and Throat

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).

Endocrine and Metabolic

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.

Eye

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.

Gastrointestinal

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.

Hematological Disorders

Rare was anemia.

Musculoskeletal

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.

Neurological

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.

Respiratory

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

Skin

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.

Breasts

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

Urogenital

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.

Miscellaneous

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 Sumatriptan

The following adverse events occurred in clinical trials with Sumatriptan Injection and Sumatriptan Nasal Spray. Because the reports include events observed in open and uncontrolled studies, the role of Sumatriptan 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.

Atypical Sensations

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

Cardiovascular

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 Symptoms

Chest discomfort.

Endocrine and Metabolic

Dehydration.

Ear, Nose, and Throat

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

Eye

Vision alterations.

Gastrointestinal

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

Injection Site Reaction

Miscellaneous

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

Mouth and Teeth

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

Musculoskeletal

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

Neurological

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.

Respiratory

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

Skin

Skin eruption, herpes, and peeling of the skin.

Urogenital

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.

Blood

Hemolytic anemia, pancytopenia, thrombocytopenia.

Cardiovascular

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

Ear, Nose, and Throat

Deafness.

Eye

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

Gastrointestinal

Ischemic colitis with rectal bleeding, xerostomia.

Hepatic

Elevated liver function tests.

Neurological

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

Non-Site Specific

Angioneurotic edema, cyanosis, death, temporal arteritis.

Psychiatry

Panic disorder.

Respiratory

Bronchospasm in patients with and without a history of asthma.

Skin

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.

Urogenital

Acute renal failure.

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