Sumavel DosePro Side Effects
Generic Name: sumatriptan
Note: This page contains side effects data for the generic drug sumatriptan. It is possible that some of the dosage forms included below may not apply to the brand name Sumavel DosePro.
It is possible that some side effects of Sumavel DosePro 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
Other dosage forms:
As well as its needed effects, sumatriptan (the active ingredient contained in Sumavel DosePro) 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
- blurred vision
- changes in patterns and rhythms of speech
- chest pain or tightness
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- muscle cramps and stiffness
- neck, throat, or jaw pain
- swelling of the fingers, hands, feet, or lower legs
- tightness in the chest
- trouble breathing
- 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
- unusual bleeding or bruising
- vomiting of blood or material that looks like coffee grounds
- weakness of the arms and legs
- 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
- 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
- increased sensitivity of the eyes to sunlight
- joint pain
- muscle aching or cramping
- muscle stiffness or tightness
- swollen joints
- trouble sleeping
- 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
For Healthcare Professionals
Applies to sumatriptan: nasal spray, oral tablet, subcutaneous kit, subcutaneous solution
The most common side effects associated with sumatriptan (the active ingredient contained in Sumavel DosePro) 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.
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 Sumavel DosePro) 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.
Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, flushing, transient increases in blood pressure (arising soon after treatment)
Uncommon (0.1% to 1%): Hypertension, hypotension, bradycardia, tachycardia, palpitations, pulsating sensations, 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), syncope
Rare (less than 0.1%): Arrhythmia, abnormal pulse, vasodilation, Raynaud's phenomenon
Frequency not reported: Abdominal aortic aneurysm, angina, atherosclerosis, heart block, peripheral cyanosis, phlebitis, thrombosis, transient myocardial ischemia, edema, cerebrovascular lesion, coronary artery vasospasm,
Postmarketing reports: Hypotension, palpitations, cyanosis, myocardial infarction
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.
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.
Very common (10% or more): Dizziness, vertigo
Common (1% to 10%): Paraesthesia (all types), hypoesthesia, vertigo, bad/unusual taste, drowsiness/sedation, headache
Rare (less than 0.1%): Transient hemiplegia, myoclonia, monoplegia/diplegia, disturbances of smell, hyperesthesia, dysesthesia
Frequency not reported: Cerebral ischemia, cerebrovascular lesion, cluster headache, convulsions, migraine, neuralgia, raised intracranial pressure, syncope, facial paralysis, bradylogia, incoordination, increased alertness, memory disturbance, motor dysfunction, paralysis, radiculopathy, speech disturbance, seizures
Postmarketing reports: Central nervous system vasculitis, cerebrovascular accident, subarachnoid hemorrhage, temporal arteritis, cerebellar infarction
It is unclear whether the nausea and vomiting is related to sumatriptan (the active ingredient contained in Sumavel DosePro) therapy or to the underlying condition.
Common (1% to 10%): Nausea and/or vomiting, abdominal discomfort, dysphagia
Uncommon (0.1% to 1%): Gastroesophageal reflux, diarrhea
Rare (less than 0.1%): Peptic ulcer, retching, flatulence/eructation, gallstones
Frequency not reported: Abdominal distention, colitis, constipation, dental pain, dyspeptic symptoms, feelings of gastrointestinal pressure, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, melena, oral itching and irritation, pancreatitis, salivary gland swelling, swallowing disorders, disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth), ischemic colitis
Very common (10% or more): Atypical sensations such as tingling, warm or hot sensations
Common (1% to 10%): Atypical sensations such as burning sensation, pain and other pressure sensations, prickling sensations, stinging sensations, facial pain, pain where the location is specified, feeling of pressure, tightness or heaviness, numbness, malaise, fatigue, feeling strange, tight feeling in head, jaw discomfort, weakness, neck pain/stiffness, chills, sensation of lightness
Rare (less than 0.1%): Pallor, intoxication, simultaneous hot and cold sensations, tickling sensations, fever
Frequency not reported: Ear nose, and throat hemorrhage, ear infection, external otitis, feeling of fullness in the ear(s), hearing disturbances, hearing loss, Meniere's disease, otalgia, sensitivity to noise, tinnitus, photophobia, contusions, overdose, swelling of extremities, swelling of face
Postmarketing reports: Deafness, serotonin syndrome
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.
One report has suggested that "throat tightness" and chest pain associated with sumatriptan may sometimes be attributable to changes in esophageal motility.
Common (1% to 10%): Sweating
Uncommon (0.1% to 1%): Erythema, pruritus, skin rashes, eruptions
Rare (less than 0.1%): Skin tenderness
Frequency not reported: Dry/scaly skin, eczema, seborrheic dermatitis, skin nodules, tightness of skin, wrinkling of skin, hematoma, hyperhidrosis
Postmarketing reports: Exacerbation of sunburn, allergic vasculitis, urticaria, photosensitivity
Frequency not reported: Elevated thyrotropin stimulating hormone (TSH) levels, endocrine cysts, lumps, and masses, hypothyroidism
Rare (less than 0.1%): Dysuria, dysmenorrhea
Frequency not reported: Breast swelling, cysts, disorder of breasts, lumps, masses of breasts, nipple discharge, breast tenderness, galactorrhea, abnormal menstrual cycle, abortion, bladder inflammation, endometriosis, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, menstruation symptoms, micturition disorders, urethritis, urinary infections
Frequency not reported: Anemia, lymphadenopathy
Postmarketing reports: Hemolytic anemia, thrombocytopenia, pancytopenia
Uncommon (0.1% to 1%): Minor disturbances in liver function tests
Frequency not reported: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis
Postmarketing reports: Angioedema
Rare (less than 0.1%): Influenza
Frequency not reported: Herpes
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
-Following subcutaneous administration: Pain, redness, stinging, induration, swelling, contusion, subcutaneous bleeding, lipoatrophy, lipohypertrophy
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.
Uncommon (0.1% to 1%): Thirst
Rare (less than 0.1%): Polydipsia, dehydration, reduced appetite, hunger
Frequency not reported: Fluid disturbances, hyperglycemia, hypoglycemia, weight gain, weight loss, fluid retention
Common (1% to 10%): Dystonia, tremor, muscle cramps, myalgia
Uncommon (0.1% to 1%): Joint disturbances (pain, stiffness, swelling, ache)
Rare (less than 0.1%): Muscle stiffness, need to flex calf muscles, backache, muscle tiredness, swelling of the extremities
Frequency not reported: Acquired musculoskeletal deformity, arthralgia, articular rheumatitis, arthritis, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, tetany, rigidity, twitching, difficulty in walking
Loss of vision included reports of permanent defects. Causality has not been established as visual disorders may occur during a migraine attack itself.
Common (1% to 10%): Vision alterations
Uncommon (0.1% to 1%): Irritation of the eye, photophobia, lacrimation
Frequency not reported: Accommodation disorders, low vision, blindness, conjunctivitis, disorders of sclera, external ocular muscle disorders, eye edema and swelling, eye hemorrhage, eye itching, eye pain, keratitis, mydriasis, visual disturbances, nystagmus, scotoma, flickering, diplopia
Postmarketing reports: Ischaemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis
Frequency not reported: Primary malignant breast neoplasm, neoplasm of pituitary
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Mental confusion, euphoria, agitation, relaxation
Rare (less than 0.1%): Hysteria, globus hystericus, depression, sleep disturbance, difficulties in concentration, dysarthria
Frequency not reported: Apathy, aggressiveness, depressive disorders, detachment, disturbance of emotions, drug abuse, hallucinations, neurotic disorders, phobia, stress, suicide, personality change, psychomotor disorders, voice disturbances
Rare (less than 0.1%): Renal calculus
Postmarketing reports: Acute renal failure
The consequences of repeated and prolonged use of the nasal spray on nasal and/or respiratory mucosa have not been established.
Common (1% to 10%): Disorder/discomfort of nasal cavity/sinuses (nasal administration, subcutaneous administration), throat discomfort (nasal administration), bronchospasm, dyspnea
Rare (less than 0.1%): Yawning, diseases of the lower respiratory tract, hiccoughs
Frequency not reported: Allergic rhinitis, nasal inflammation, sinusitis, upper respiratory tract inflammation, asthma, breathing disorder, bronchitis, cough
Postmarketing reports: Shortness of breath (as part of hypersensitivity reaction)
More about Sumavel DosePro (sumatriptan)
- Sumavel DosePro
- Sumavel DosePro injection
- Sumavel DosePro (Advanced Reading)
- Sumavel DosePro Subcutaneous (Advanced Reading)
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