Sumatriptan side effects

List of side effects
Cardiac events Hypertensive episodes Drug-associated cerebrovascular events/fatalities Vasospasm-related events Serotonin syndrome Local irritation Incidence in controlled clinical trials Other events observed in association with the administration of Imitrex Nasal Spray Other events observed in the clinical development of IMITREX Postmarketing experience (reports for subcutaneous or oral Sumatriptan)
 * Myocardial ischemia and/or infarction and other adverse cardiac events
 * Drug-associated cardiac events/fatalities
 * Pre-marketing experience with sumatriptan (cardiac events)
 * Post-marketing experience with sumatriptan (cardiac events)

Cardiac events
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. Return to top

Myocardial ischemia and/or infarction and other adverse cardiac events
Sumatriptan should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD). It is strongly recommended that sumatriptan not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient’s medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, sumatriptan should not be administered. For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of sumatriptan nasal spray take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received sumatriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following Imitrex Nasal Spray, in these patients with risk factors. It is recommended that patients who are intermittent long-term users of sumatriptan and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use sumatriptan. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to sumatriptan. Return to top

Drug-associated cardiac events/fatalities
Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of IMITREX® (sumatriptan succinate) Injection or IMITREX® (sumatriptan succinate) Tablets. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. The fact that sumatriptan can cause coronary vasospasm, that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to sumatriptan use support the conclusion that some of these cases were caused by the drug. In many cases, however, where there has been known underlying coronary artery disease, the relationship is uncertain. Return to top

Pre-marketing experience with sumatriptan (cardiac events)
Among approximately 4,000 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of sumatriptan nasal spray, 1 patient experienced an asymptomatic subendocardial infarction possibly subsequent to a coronary vasospastic event. Of 6,348 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of oral sumatriptan, 2 experienced clinical adverse events shortly after receiving oral sumatriptan that may have reflected coronary vasospasm. Neither of these adverse events was associated with a serious clinical outcome. Among the more than 1,900 patients with migraine who participated in premarketing controlled clinical trials of subcutaneous sumatriptan, there were 8 patients who sustained clinical events during or shortly after receiving sumatriptan that may have reflected coronary artery vasospasm. Six of these 8 patients had ECG changes consistent with transient ischemia, but without accompanying clinical symptoms or signs. Of these 8 patients, 4 had either findings suggestive of CAD or risk factors predictive of CAD prior to study enrollment. Return to top

Post-marketing experience with sumatriptan (cardiac events)
Serious cardiovascular events, some resulting in death, have been reported in association with the use of IMITREX Injection or IMITREX Tablets. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of the reported cases that were actually caused by sumatriptan or to reliably assess causation in individual cases. On clinical grounds, the longer the latency between the administration of IMITREX and the onset of the clinical event, the less likely the association is to be causative. Accordingly, interest has focused on events beginning within 1 hour of the administration of IMITREX. Cardiac events that have been observed to have onset within 1 hour of sumatriptan administration include: coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation, cardiac arrest, and death. Some of these events occurred in patients who had no findings of CAD and appear to represent consequences of coronary artery vasospasm. However, among domestic reports of serious cardiac events within 1 hour of sumatriptan administration, almost all of the patients had risk factors predictive of CAD and the presence of significant underlying CAD was established in most cases. Return to top

Hypertensive episodes
Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. Sumatriptan is contraindicated in patients with uncontrolled hypertension. Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients. Return to top

Drug-associated cerebrovascular events/fatalities
Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral or subcutaneous sumatriptan, and some have resulted in fatalities. The relationship of sumatriptan to these events is uncertain. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should also be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., cerebrovascular accident, transient ischemic attack). Return to top

Vasospasm-related events
Sumatriptan may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Very rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of sumatriptan. Visual disorders may also be part of a migraine attack. Return to top

Serotonin syndrome
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with IMITREX, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Return to top

Local irritation
Of the 3,378 patients using the nasal spray (5-, 10-, or 20-mg doses) on 1 or 2 occasions in controlled clinical studies, approximately 5% noted irritation in the nose and throat. Irritative symptoms such as burning, numbness, paresthesia, discharge, and pain or soreness were noted to be severe in about 1% of patients treated. The symptoms were transient and in approximately 60% of the cases, the symptoms resolved in less than 2 hours. Limited examinations of the nose and throat did not reveal any clinically noticeable injury in these patients. The consequences of extended and repeated use of IMITREX Nasal Spray on the nasal and/or respiratory mucosa have not been systematically evaluated in patients. No increase in the incidence of local irritation was observed in patients using Imitrex Nasal Spray repeatedly for up to 1 year. In inhalation studies in rats dosed daily for up to 1 month at exposures as low as one half the maximum daily human exposure (based on dose per surface area of nasal cavity), epithelial hyperplasia (with and without keratinization) and squamous metaplasia were observed in the larynx at all doses tested. These changes were partially reversible after a 2-week drug-free period. When dogs were dosed daily with various formulations by intranasal instillation for up to 13 weeks at exposures of 2 to 4 times the maximum daily human exposure (based on dose per surface area of nasal cavity), respiratory and nasal mucosa exhibited evidence of epithelial hyperplasia, focal squamous metaplasia, granulomata, bronchitis, and fibrosing alveolitis. A no-effect dose was not established. The changes observed in both species are not considered to be signs of either preneoplastic or neoplastic transformation. Local effects on nasal and respiratory tissues after chronic intranasal dosing in animals have not been studied. Return to top

Incidence in controlled clinical trials
Among 3,653 patients treated with Imitrex Nasal Spray in active- and placebo-controlled clinical trials, less than 0.4% of patients withdrew for reasons related to adverse events. Table 2 lists adverse events that occurred in worldwide placebo-controlled clinical trials in 3,419 migraineurs. 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. Only events that occurred at a frequency of 1% or more in the Imitrex Nasal Spray 20-mg treatment group and were more frequent in that group than in the placebo group are included in the following list: Phonophobia also occurred in more than 1% of patients but was more frequent on placebo. IMITREX Nasal Spray is 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, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse events. Return to top
 * Atypical sensations: burning sensation
 * Ear/nose/throat: disorder/discomfort of nasal cavity/sinuses, throat discomfort
 * Gastrointestinal: nausea and/or vomiting
 * Neuroligical: bad/unusual taste, dizziness/vertigo

Other events observed in association with the administration of Imitrex Nasal Spray
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 Nasal Spray 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 the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Imitrex Nasal Spray (5, 10, or 20 mg in controlled and uncontrolled trials) and reported an event divided by the total number of patients (N = 3,711) exposed to Imitrex Nasal Spray. 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: 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 Cardiovascular Chest symptoms Ear/nose/throat Endocrine/metabolic Eye Gastrointestinal Mouth/teeth Musculoskeletal Neurological Respiratory Skin Urogenital Miscellaneous Return to top
 * Infrequent were tingling, warm/hot sensation, numbness, pressure sensation, feeling strange, feeling of heaviness, feeling of tightness, paresthesia, cold sensation, and tight feeling in head.
 * Rare were dysesthesia and prickling sensation.
 * Infrequent were flushing and hypertension, palpitations, tachycardia, changes in ECG, and arrhythmia.
 * Rare were abdominal aortic aneurysm, hypotension, bradycardia, pallor, and phlebitis.
 * Infrequent were chest tightness, chest discomfort, and chest pressure/heaviness.
 * Infrequent were disturbance of hearing and ear infection.
 * Rare were otalgia and Meniere disease.
 * Infrequent was thirst.
 * Rare were galactorrhea, hypothyroidism, and weight loss.
 * Infrequent were irritation of eyes and visual disturbance.
 * Infrequent were abdominal discomfort, diarrhea, dysphagia, and gastroesophageal reflux.
 * Rare were constipation, flatulence/eructation, hematemesis, intestinal obstruction, melena, gastroenteritis, colitis, hemorrhage of gastrointestinal tract, and pancreatitis.
 * Infrequent was disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).
 * Infrequent were neck pain/stiffness, backache, weakness, joint symptoms, arthritis, and myalgia.
 * Rare were muscle cramps, tetany, intervertebral disc disorder, and muscle stiffness.
 * Infrequent were drowsiness/sedation, anxiety, sleep disturbances, tremors, syncope, shivers, chills, depression, agitation, sensation of lightness, and mental confusion.
 * Rare were difficulty concentrating, hunger, lacrimation, memory disturbances, monoplegia/diplegia, apathy, disturbance of smell, disturbance of emotions, dysarthria, facial pain, intoxication, stress, decreased appetite, difficulty coordinating, euphoria, and neoplasm of pituitary.
 * Infrequent were dyspnea and lower respiratory tract infection.
 * Rare was asthma.
 * Infrequent were rash/skin eruption, pruritus, and erythema.
 * Rare were herpes, swelling of face, sweating, and peeling of skin.
 * Infrequent were dysuria, disorder of breasts, and dysmenorrhea.
 * Rare were endometriosis and increased urination.
 * Infrequent were cough, edema, and fever.
 * Rare were hypersensitivity, swelling of extremities, voice disturbances, difficulty in walking, and lymphadenopathy.

Other events observed in the clinical development of IMITREX
The following adverse events occurred in clinical trials with IMITREX Injection and IMITREX Tablets. 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. Breasts Cardiovascular Ear/nose/throat Endocrine/metabolic Eye Gastrointestinal Hematological disorders Injection site reaction Miscellaneous Musculoskeletal Neurological Pain/other pressure sensations Respiratory Skin Urogenital Return to top
 * Breast swelling; cysts, lumps, and masses of breasts; nipple discharge; primary malignant breast neoplasm; and tenderness.
 * Abnormal pulse, angina, atherosclerosis, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, pulsating sensations, Raynaud syndrome, thrombosis, transient myocardial ischemia, 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), and vasodilation.
 * Allergic rhinitis; ear, nose, and throat hemorrhage; external otitis; feeling of fullness in the ear(s); hearing disturbances; hearing loss; nasal inflammation; sensitivity to noise; sinusitis; tinnitus; and upper respiratory inflammation.
 * Dehydration; endocrine cysts, lumps, and masses; elevated thyrotropin stimulating hormone (TSH) levels; fluid disturbances; hyperglycemia; hypoglycemia; polydipsia; and weight gain.
 * Accommodation disorders, blindness and low vision, conjunctivitis, disorders of sclera, external ocular muscle disorders, eye edema and swelling, eye itching, eye hemorrhage, eye pain, keratitis, mydriasis, and vision alterations.
 * Abdominal distention, dental pain, disturbances of liver function tests, dyspeptic symptoms, feelings of gastrointestinal pressure, gallstones, gastric symptoms, gastritis, gastrointestinal pain, hypersalivation, hyposalivation, oral itching and irritation, peptic ulcer, retching, salivary gland swelling, and swallowing disorders.
 * Anemia.
 * Contusions, fluid retention, hematoma, hypersensitivity to various agents, jaw discomfort, miscellaneous laboratory abnormalities, overdose, “serotonin agonist effect,” and speech disturbance.
 * Acquired musculoskeletal deformity, arthralgia and articular rheumatitis, muscle atrophy, muscle tiredness, musculoskeletal inflammation, need to flex calf muscles, rigidity, tightness, and various joint disturbances (pain, stiffness, swelling, ache).
 * Aggressiveness, bradylogia, cluster headache, convulsions, detachment, disturbances of taste, drug abuse, dystonia, facial paralysis, globus hystericus, hallucinations, headache, heat sensitivity, hyperesthesia, hysteria, increased alertness, malaise/fatigue, migraine, motor dysfunction, myoclonia, neuralgia, neurotic disorders, paralysis, personality change, phobia, photophobia, psychomotor disorders, radiculopathy, raised intracranial pressure, relaxation, stinging sensations, transient hemiplegia, simultaneous hot and cold sensations, suicide, tickling sensations, twitching, and yawning.
 * Chest pain, neck tightness/pressure, throat/jaw pain/tightness/pressure, and pain (location specified).
 * Breathing disorders, bronchitis, diseases of the lower respiratory tract, hiccoughs, and influenza.
 * Dry/scaly skin, eczema, seborrheic dermatitis, skin nodules, skin tenderness, tightness of skin, and wrinkling of skin.
 * Abortion, abnormal menstrual cycle, bladder inflammation, hematuria, inflammation of fallopian tubes, intermenstrual bleeding, menstruation symptoms, micturition disorders, renal calculus, urethritis, urinary frequency, and urinary infections.

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 Cardiovascular Ear/nose/throat Eye Gastrointestinal Hepatic Neurological Non-site specific Psychiatry Respiratory Skin Urogenital Return to top
 * Hemolytic anemia, pancytopenia, thrombocytopenia.
 * Atrial fibrillation, cardiomyopathy, colonic ischemia (see WARNINGS), 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 (see WARNINGS), xerostomia.
 * Elevated liver function tests.
 * Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage.
 * Angioneurotic edema, cyanosis, death (see WARNINGS), 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), photosensitivity.
 * Acute renal failure.