Sumatriptan Side Effects

It is possible that some side effects of sumatriptan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sumatriptan: oral tablet

As well as its needed effects, sumatriptan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sumatriptan, check with your doctor immediately:

Less common
  • Abdominal or stomach pain
  • anxiety
  • blurred vision
  • changes in patterns and rhythms of speech
  • chest pain or tightness
  • chills
  • confusion
  • dizziness
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • headache
  • muscle cramps and stiffness
  • neck, throat, or jaw pain
  • nightmares
  • shivering
  • sweating
  • swelling of the fingers, hands, feet, or lower legs
  • tightness in the chest
  • trouble breathing
Rare
  • Blindness
  • chest pain or discomfort
  • chest tightness or heaviness
  • flushing or redness of the skin, especially on the face and neck
  • increased blinking or spasms of the eyelid
  • itching, pain, redness, or swelling
  • lightheadedness, dizziness, or fainting
  • nerve pain
  • severe numbness, especially on one side of the face or body
  • severe or continuing stomach pain
  • trouble speaking or swallowing
  • twitching
  • unusual bleeding or bruising
  • vomiting of blood or material that looks like coffee grounds
  • weakness of the arms and legs
Incidence not known
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • changes in vision
  • muscle twitching
  • pinpoint red spots on the skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • skin rash, hives, or itching
  • unexplained bleeding or bruising
  • unusually warm skin
  • weakness in the arm or leg on one side of the body, sudden and severe

Some sumatriptan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in color vision
  • change in hearing
  • difficulty with concentrating
  • drowsiness
  • heartburn
  • increased sensitivity of the eyes to sunlight
  • joint pain
  • muscle aching or cramping
  • muscle stiffness or tightness
  • swollen joints
  • trouble sleeping
Rare
  • Aggressiveness
  • belching
  • change in taste
  • feeling halos around lights
  • increased sensitivity to pain
  • loss of appetite
  • numbness, pain, tingling, or weakness
  • stomach discomfort or upset
  • tingling in the hands and feet
  • tunnel vision
  • weakness

For Healthcare Professionals

Applies to sumatriptan: nasal spray, oral tablet, subcutaneous kit, subcutaneous solution

General

The most common side effects associated with sumatriptan include pain, sensations of tingling, heat or cold, heaviness, pressure, or tightness. These are usually transient and may be intense and can affect any part of the body, including the chest and throat.

Other common effects include mild to moderate and transient flushing, dizziness, feelings of weakness; fatigue, drowsiness, sensory disturbance including paraesthesia and hypoesthesia, transient increases in blood pressure, and dyspnea. Flushing, paraesthesia, and sensations of heat, pressure, and heaviness may be more common after sumatriptan injection; nausea and vomiting appear less frequently with subcutaneous administration than with tablets.

The most common side effects associated with subcutaneous injection of sumatriptan include transient pain at the injection site, stinging/burning, swelling, erythema, bruising, and bleeding at the injection site. A similar profile of clinical adverse events has been reported with sumatriptan tablets and nasal spray.[Ref]

Cardiovascular

Life-threatening disturbances of cardiac rhythm, such as ventricular tachycardia and ventricular fibrillation leading to death, and rare reports of acute myocardial infarction, have been reported within a few hours after administration of 5-HT1 agonists.

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 reported to be 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.[Ref]

Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, flushing, neck/throat/jaw pain/tightness/pressure, transient increases in blood pressure (arising soon after treatment)
Uncommon (0.1% to 1%): Bradycardia, hypertension, hypotension, palpitations, pulsating sensations, tachycardia, 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)
Rare (less than 0.1%): Abnormal pulse, arrhythmia, pallor, Raynaud's phenomenon, vasodilation
Frequency not reported: Abdominal aortic aneurysm, angina, atherosclerosis, cerebrovascular lesion, coronary artery vasospasm, edema, heart block, peripheral cyanosis, phlebitis, thrombosis, transient myocardial ischemia
Postmarketing reports: Cyanosis, hypotension, myocardial infarction, palpitations[Ref]

Nervous system

Very common (10% or more): Dizziness
Common (1% to 10%): Bad/unusual taste, drowsiness/sedation, dystonia, headache, hypoesthesia, paraesthesia (all types), tremor
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Difficulties in concentration, disturbances of smell, dysarthria, dysesthesia, hyperesthesia, monoplegia/diplegia, myoclonia, transient hemiplegia
Frequency not reported: Bradylogia, cerebral ischemia, cerebrovascular lesion, cluster headache, convulsions, facial paralysis, incoordination, increased alertness, memory disturbance, migraine, motor dysfunction, neuralgia, nystagmus, paralysis, radiculopathy, raised intracranial pressure, seizures, speech disturbance
Postmarketing reports: Central nervous system vasculitis, cerebellar infarction, cerebrovascular accident, subarachnoid hemorrhage, serotonin syndrome, temporal arteritis[Ref]

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 treatment; some have resulted in fatalities. One case of sumatriptan-induced cortical stroke has been reported in a patient with sagittal sinus thrombosis. In some cases, it appears possible that the cerebrovascular events were primary, and the 5-HT1 agonist administered in the belief that presenting symptoms were due to migraine when they were not. Patients with migraine may also be at an increased risk of certain cerebrovascular events such as stroke, hemorrhage, and transient ischemic attacks.

Medication overuse headache may present as migraine-like headaches or as a marked increase in frequency of migraine attacks.

Serotonin syndrome is characterized by 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). The onset of symptoms generally occurs within minutes to hours or receiving a new or a greater dose of a serotoninergic medications.

Seizures have been reported in patients with either a history of seizures or concurrent conditions predisposing to seizures and also in patients where no such predisposing factors are apparent.[Ref]

Gastrointestinal

It is unclear whether the nausea and vomiting is related to sumatriptan therapy or to the underlying condition.

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

Common (1% to 10%): Abdominal discomfort, dysphagia, nausea and/or vomiting
Uncommon (0.1% to 1%): Diarrhea, gastroesophageal reflux
Rare (less than 0.1%): Flatulence/eructation, gallstones, peptic ulcer, retching
Frequency not reported: Abdominal distention, colitis, constipation, dental pain, disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth), dyspeptic symptoms, feelings of gastrointestinal pressure, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, ischemic colitis, melena, oral itching and irritation, pancreatitis, salivary gland swelling, swallowing disorders[Ref]

Other

Very common (10% or more): Atypical sensations such as tingling, warm or hot sensations, vertigo
Common (1% to 10%): Atypical sensations such as burning sensation, chills, facial pain, fatigue, feeling of pressure, feeling strange, jaw discomfort, malaise, neck pain/stiffness, numbness, pain and other pressure sensations, pain where the location is specified, prickling sensations, stinging sensations, sensation of lightness, tight feeling in head, tightness or heaviness, weakness
Rare (less than 0.1%): Fever, intoxication, simultaneous hot and cold sensations, swelling of the extremities, tickling sensations
Frequency not reported: Abortion, contusions, ear infection, ear, nose, and throat hemorrhage, external otitis, feeling of fullness in the ear(s), hearing disturbances, hearing loss, Meniere's disease, otalgia, overdose, photophobia, sensitivity to noise, swelling of face, tinnitus
Postmarketing reports: Deafness[Ref]

Dermatologic

Common (1% to 10%): Sweating
Uncommon (0.1% to 1%): Eruptions, erythema, pruritus, skin rashes
Rare (less than 0.1%): Skin tenderness
Frequency not reported: Dry/scaly skin, eczema, hematoma, hyperhidrosis, seborrheic dermatitis, skin nodules, tightness of skin, wrinkling of skin
Postmarketing reports: Allergic vasculitis, angioedema, exacerbation of sunburn, photosensitivity, urticaria[Ref]

Endocrine

Frequency not reported: Elevated thyrotropin stimulating hormone (TSH) levels, endocrine cysts, lumps, and masses, hypothyroidism[Ref]

Genitourinary

Rare (less than 0.1%): Dysmenorrhea, dysuria
Frequency not reported: Abnormal menstrual cycle, bladder inflammation, breast swelling, breast tenderness, cysts, disorder of breasts, endometriosis, galactorrhea, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, lumps, masses of breasts, menstruation symptoms, micturition disorders, nipple discharge, urethritis, urinary infections[Ref]

Hematologic

Frequency not reported: Anemia, lymphadenopathy
Postmarketing reports: Hemolytic anemia, pancytopenia, thrombocytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Minor disturbances in liver function tests[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis[Ref]

Immunologic

Rare (less than 0.1%): Influenza
Frequency not reported: Herpes[Ref]

Local

Local irritative symptoms were reported in clinical trials with sumatriptan nasal spray in approximately 5% of patients, and were severe in about 1% of cases. Symptoms were noted as being transient and generally resolved in less than 2 hours.[Ref]

Very common (10% or more): Injection site reaction
Common (1% to 10%): Burning sensation (nasal administration)
Frequency not reported: Injection site stinging/burning, swelling, erythema, bruising, and bleeding
Postmarketing reports:
-Following subcutaneous administration: Contusion, induration, lipoatrophy, lipohypertrophy, pain, redness, stinging, subcutaneous bleeding, swelling[Ref]

Metabolic

Uncommon (0.1% to 1%): Thirst
Rare (less than 0.1%): Dehydration, hunger, polydipsia, reduced appetite
Frequency not reported: Fluid disturbances, fluid retention, hyperglycemia, hypoglycemia, weight gain, weight loss[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, myalgia
Uncommon (0.1% to 1%): Joint disturbances (pain, stiffness, swelling, ache)
Rare (less than 0.1%): Backache, muscle stiffness, muscle tiredness, need to flex calf muscles
Frequency not reported: Acquired musculoskeletal deformity, arthralgia, arthritis, articular rheumatitis, difficulty in walking, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, rigidity, tetany, twitching[Ref]

Ocular

Common (1% to 10%): Vision alterations
Uncommon (0.1% to 1%): Irritation of the eye, lacrimation, photophobia
Frequency not reported: Accommodation disorders, blindness, conjunctivitis, diplopia. disorders of sclera, low vision, eye edema and swelling, eye hemorrhage, eye itching, eye pain, external ocular muscle disorders, flickering, keratitis, mydriasis, scotoma, visual disturbances
Postmarketing reports: Ischaemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis[Ref]

Loss of vision included reports of permanent defects. Causality has not been established as visual disorders may occur during a migraine attack itself.[Ref]

Oncologic

Frequency not reported: Neoplasm of pituitary, primary malignant breast neoplasm[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Agitation, euphoria, mental confusion, relaxation
Rare (less than 0.1%): Depression, globus hystericus, hysteria, sleep disturbance
Frequency not reported: Aggressiveness, apathy, depressive disorders, detachment, disturbance of emotions, drug abuse, hallucinations, neurotic disorders, personality change, phobia, psychomotor disorders, stress, suicide[Ref]

Renal

Rare (less than 0.1%): Renal calculus
Postmarketing reports: Acute renal failure[Ref]

Respiratory

Common (1% to 10%): Bronchospasm, disorder/discomfort of nasal cavity/sinuses (nasal administration, subcutaneous administration), dyspnea, throat discomfort (nasal administration)
Rare (less than 0.1%): Diseases of the lower respiratory tract, hiccoughs, yawning
Frequency not reported: Allergic rhinitis, asthma, breathing disorder, bronchitis, cough, nasal inflammation, sinusitis, upper respiratory tract inflammation, voice disturbances
Postmarketing reports: Shortness of breath (as part of hypersensitivity reaction)[Ref]

The consequences of repeated and prolonged use of the nasal spray on nasal and/or respiratory mucosa have not been established.[Ref]

References

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2. "Drugs for migraine." Med Lett Drugs Ther 37 (1995): 17-20

3. "Treatment of migraine attacks with sumatriptan. the subcutaneous sumatriptan international study group." N Engl J Med 325 (1991): 316-21

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. SUMAtriptan Succinate (SUMAtriptan)." Bedford Laboratories, Bedford, OH.

6. "Product Information. Alsuma (SUMAtriptan)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

7. Schoenen J, Bulcke J, Caekebeke J, Dehaene I, Dekeyser J, Hildebrand G, Joffroy A, Laloux P, Louis P, Monseu G, Pierre P, Vander "Self-treatment of acute migraine with subcutaneous sumatriptan using an auto-injector device - comparison with customary treatment in an open, longitudinal study." Cephalalgia 14 (1994): 55-63

8. Welch KM "Drug therapy of migraine." N Engl J Med 329 (1993): 1476-83

9. "Product Information. Imitrex (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.

10. "Product Information. Imitrex nasal spray (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.

11. Ottervanger JP, Paalman HJ, Boxma GL, Stricker BH "Transmural myocardial infarction with sumatriptan." Lancet 341 (1993): 861-2

12. Ottervanger JP, van Witsen TB, Valkenburg HA, Stricker BH "Postmarketing study of cardiovascular adverse reactions associated with sumatriptan." BMJ 307 (1993): 1185

13. Morgan DR, Trimble M, McVeigh GE "Atrial fibrillation associated with sumatriptan." Br Med J 321 (2000): 275

14. Visser WH, Devriend RHM, Jaspers NMWH, Ferrari MD "Sumatriptan in clinical practice: a 2-year review of 453 migraine patients." Neurology 47 (1996): 46-51

15. Willett F, Curzen N, Adams J, Armitage M "Coronary vasospasm induced by subcutaneous sumatriptan." BMJ 304 (1992): 1415

16. MacLean MR, Smith GC, Templeton AG "Adverse reactions associated with sumatriptan." Lancet 341 (1993): 1092

17. Visser WH, Jaspers NMWH, Devriend RHM, Ferrari MD "Chest symptoms after sumatriptan: a two-year clinical practice review in 735 consecutive migraine patients." Cephalalgia 16 (1996): 554-9

18. Mueller L, Gallagher RM, Ciervo CA "Vasospasm-induced myocardial infarction with sumatriptan." Headache 36 (1996): 329-31

19. Curtin T, Brooks AP, Roberts JA "Cardiorespiratory distress after sumatriptan given by injection." BMJ 305 (1992): d713-4

20. Ottervanger JP, Vanwitsen TB, Valkenburg HA, Grobbee DE, Stricker BHC "Adverse reactions attributed to sumatriptan - a postmarketing study in general practice." Eur J Clin Pharmacol 47 (1994): 305-9

21. Dachs R, Vitillo J "Angioedema associated with sumatriptan administration." Am J Med 99 (1995): 684-5

22. Loi V, Lai M, Pisano MR, Delzompo M "Sumatriptan and panic-like symptoms." Am J Psychiatry 153 (1996): 1505

23. Lopezalemany M, Ferrertuset C, Bernaceralpera B "Akathisia and acute dystonia induced by sumatriptan." J Neurol 244 (1997): 131-2

24. Cavazos JE, Caress JB, Chilukuri VR, Devlin T, Gray L, Hurwitz BJ "Sumatriptan-induced stroke in sagittal sinus thrombosis." Lancet 343 (1994): 1105-6

25. Spierings EL "Intracranial hemorrhages associated with sumatriptan." Neurology 57 (2001): 2322

26. Luman W, Gray RS "Adverse reactions associated with sumatriptan." Lancet 341 (1993): 1091-2

27. Doctor's Guide to Medical & Other News "AAN meeting: sumatriptan linked to life-threatening intestinal condition. Available from: URL: http://www.pslgroup.com/dg/f9902.htm." ([1999 Apr 26]):

28. "Product Information. Imitrex injection (sumatriptan)." Cerenex Pharmaceuticals, Research Triangle Pk, NC.

29. Franceschini R, Cataldi A, Garibaldi A, Cianciosi P, Scordamaglia A, Barreca T, Rolandi E "The effects of sumatriptan on pituitary secretion in man." Neuropharmacology 33 (1994): 235-9

30. "Treatment of acute cluster headache with sumatriptan. the sumatriptan cluster headache study group." N Engl J Med 325 (1991): 322-6

31. Chiari M, Manzoni GC, Vandegeijn EJ "Ischemic optic neuropathy after sumatriptan in a migraine with aura patient." Headache 34 (1994): 237-8

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