Tosymra Side Effects

Generic name: sumatriptan

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 10, 2024.

Note: This document provides detailed information about Tosymra Side Effects associated with sumatriptan. Some dosage forms listed on this page may not apply specifically to the brand name Tosymra.

Applies to sumatriptan: subcutaneous kit, subcutaneous solution.

Other dosage forms:

• oral tablet
• nasal powder, nasal spray

Common side effects of Tosymra

Some side effects of sumatriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• burning or tingling sensation
• drowsiness
• feeling of constant movement of self or surroundings
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm feeling
• sensation of spinning
• sleepiness

Less common

• anxiety
• bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• change in taste
• difficulty seeing at night
• difficulty with moving
• discomfort in the jaw, nasal cavity, or throat
• false or unusual sense of well-being
• feeling strange
• heartburn
• increased sensitivity of the eyes to sunlight
• joint pain, stiffness, or swelling
• mental confusion
• muscle aching or cramping
• neck pain or stiffness
• red, sore eyes
• stomach discomfort
• swollen joints
• tearing of the eyes
• thirst
• weakness

Rare

• backache
• belching
• bloated or full feeling
• changes in patterns and rhythms of speech
• cramps
• dry heaves
• excess air or gas in the stomach or bowels
• extreme thirst
• heavy bleeding
• hiccups
• hunger
• increased thirst
• muscle tiredness
• muscle twitching or jerking
• pain
• passing gas
• reduced appetite
• rhythmic movement of muscles
• severe stomach pain with nausea and vomiting
• tenderness of the skin

Incidence not known

• deafness
• panic
• severe sunburn

Serious side effects of Tosymra

Along with its needed effects, sumatriptan (the active ingredient contained in Tosymra) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sumatriptan:

Less common

• blurred vision
• chest pain or discomfort
• chills
• confusion
• difficult or labored breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• headache
• nervousness
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• slow heartbeat
• sweating
• tight feeling in the head
• tightness or pressure in the chest
• trembling or shaking of the hands or feet
• unusual tiredness or weakness

Rare

• black, tarry stools
• blood in the urine
• blood in the vomit
• burning while urinating
• cough
• decreased urination
• depression of the skin
• diarrhea
• dry mouth
• feeling of warmth or heat
• fever
• flushing or redness of the skin, especially on the face and neck
• general feeling of discomfort or illness
• inability to move the eyes
• inability to move the legs or arms
• increase in heart rate
• increased blinking or spasms of the eyelid
• increased sensitivity to pain
• increased sensitivity to touch
• indentation of the skin
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• pain in the groin or genitals
• paleness of the skin
• paleness or cold feeling in the fingertips and toes
• paralysis of one side of the body
• rapid breathing
• runny nose
• severe or continuing stomach pain
• sharp back pain just below the ribs
• shivering
• sore throat
• sticking out of the tongue
• sunken eyes
• thirst
• tingling in the hands and feet
• tingling or pain in the fingers or toes when exposed to cold
• trouble sleeping
• trouble speaking or swallowing
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions
• vomiting
• wrinkled skin

Incidence not known

• agitation
• back, leg, or stomach pains
• bleeding gums
• blood in the stools
• bluish color of the fingernails, lips, skin, palms, or nail beds
• changes in skin color
• changes in vision
• decreased awareness or responsiveness
• depression
• double vision
• general body swelling
• headache, sudden, severe, and continuing
• high fever
• hives or itching
• hostility
• inability to speak
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of ability to use or understand speech or language
• loss of appetite
• loss of consciousness
• loss of vision
• migraine headache
• muscle twitching
• noisy breathing
• nosebleeds
• overactive reflexes
• pain, tenderness, or swelling of the foot or leg
• pinpoint red spots on the skin
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• rectal bleeding
• redness, soreness, or itching skin
• restlessness
• seizures
• severe or sudden headache
• severe sleepiness
• slurred speech
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• stomach pain and tenderness
• swelling of the face, ankles, hands, feet, or lower legs
• swollen glands
• talking or acting with excitement you cannot control
• temporary blindness
• trembling or shaking
• twitching
• unexplained bleeding or bruising
• unusual bleeding or bruising
• unusual drowsiness, dullness, or feeling of sluggishness
• unusually warm skin
• weakness in the arm or leg on one side of the body, sudden and severe
• weight loss
• yellowing of the eyes or skin

For healthcare professionals

Applies to sumatriptan: nasal capsule, nasal spray, oral tablet, subcutaneous kit, subcutaneous solution, transdermal film extended release.

General

The more commonly observed adverse reactions have included those of pressure sensation, flushing, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, flushing, and numbness; formulation specific events including injection site reactions, application site pain, and nasal discomfort have been reported.^[Ref]

Cardiovascular

• 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]

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 active ingredient contained in Tosymra) 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]

Nervous system

• Very common (10% or more): Dizziness (10%), abnormal taste (20%; nasal powder)
• 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 of 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

• 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]

It is unclear whether the nausea and vomiting is related to sumatriptan (the active ingredient contained in Tosymra) 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]

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

• Very common (10% or more): Application site pain (26%; transdermal patch)
• Common (1% to 10%): Sweating, allergic contact dermatitis and application site paresthesia/pruritus/warmth/discomfort/irritation/site discoloration (transdermal patch)
• 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, burns scars, severe redness, pain, skin discoloration, blistering and cracked skin with the iontophoretic transdermal system^[Ref]

Burns and scars have been reported on the skin where the transdermal iontophoretic transdermal system has been worn. These reports describe severe redness, pain, skin discoloration, blistering, and cracked skin. On June 13, 2016, the manufacturer of the patch suspended sales and distribution of the patch to investigate the cause of these reports.^[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

• 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]

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]

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

• Very common (10% or more): Nasal discomfort (up to 11%; nasal powder)
• Common (1% to 10%): Bronchospasm, disorder/discomfort of nasal cavity/sinuses (nasal administration, subcutaneous administration), dyspnea, throat discomfort (nasal administration); rhinitis (nasal administration), rhinorrhea (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]

Frequently asked questions

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Further information

Tosymra side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer