Sumavel DosePro Side Effects
Generic name: sumatriptan
Note: This document contains side effect information about sumatriptan. Some of the dosage forms listed on this page may not apply to the brand name Sumavel DosePro.
Some side effects of Sumavel DosePro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to sumatriptan: oral tablet
Along with its needed effects, sumatriptan (the active ingredient contained in Sumavel DosePro) 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
- 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 with breathing, 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
- flushing or redness of the skin
- 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
- unexplained bleeding or bruising
- unusually warm skin
- weakness in the arm or leg on one side of the body, sudden and severe
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: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
- itching skin
- joint pain
- muscle aching or cramping
- muscle stiffness or tightness
- swollen joints
- trouble with 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 manufacturer (GlaxoSmithKline Inc.) encourages clinicians to report suspected adverse events to its Product Surveillance Department (1-800-334-4153).
Sumatriptan is contraindicated in patients with coronary artery disease.
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 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.
Cardiovascular side effects including serious, sometimes fatal cardiac events such as ventricular fibrillation, transient myocardial ischemia, ventricular tachycardia, and coronary artery vasospasm sometimes resulting in myocardial infarction have been reported following the administration of sumatriptan injection. Serious and/or life threatening arrhythmias including atrial fibrillation, ventricular fibrillation, ventricular tachycardia, myocardial infarction, ECG changes suggestive of myocardial ischemia and symptoms consistent with angina pectoris have been reported after administration of oral sumatriptan. Cardiomyopathy, colonic ischemia, Prinzmetal variant angina, thrombophlebitis, angioedema, cerebrovascular accident, pulmonary embolism, shock, subarachnoid hemorrhage, hypertension, bradycardia, and precordial distress have also been reported. In addition, nonspecific EKG changes including ST and T wave changes, prolongation of the PR and QTc intervals, ectopy, and syncope have been reported.
Hematologic side effects including hemolytic anemia, thrombocytopenia, pancytopenia, and cyanosis have been reported.
One report has suggested that "throat tightness" and chest pain associated with sumatriptan (the active ingredient contained in Sumavel DosePro) may sometimes be attributable to changes in esophageal motility.
General side effects including atypical sensations such as tingling, warm or hot sensations, flushing, feeling of tightness, neck stiffness, feeling of heaviness, and other sensations have been reported frequently.
Hypersensitivity side effects including rash, urticaria, pruritus, erythema, and shortness of breath have been reported. Life threatening and fatal anaphylaxis/anaphylactoid reactions have been reported rarely.
Local side effects including reactions at the site of subcutaneous injection have been reported and have included lipoatrophy, lipohypertrophy, pain, burning, swelling, and redness.
Hepatic side effects including disturbances of liver function tests and hepatic impairment have been reported.
Renal side effects including acute renal failure and angioneurotic edema have been reported.
Visual disorders may also be a part of a migraine attack.
Ocular side effects including loss of vision, vision alterations, intraocular disorders, ischemic optic neuropathy, periorbital edema, temporal arteritis, retinal vein thrombosis, and retinal artery occlusion have been reported. Both significant partial vision loss and transient or permanent blindness have been reported very rarely.
One case of sumatriptan-induced cortical stroke has been reported in a patient with sagittal sinus thrombosis.
Sumatriptan (the active ingredient contained in Sumavel DosePro) should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
Nervous system side effects including anxiety have been reported frequently. Paresthesias, dizziness, and headache have also been reported. Seizures and strokes have rarely been reported. Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, and subarachnoid hemorrhage have been part of postmarketing events which have been reported. Five cases of akathisia including one together with acute oral dystonia have been reported. Cases of intracranial hemorrhages as well as transient hemiplegia and hemiparesis have also been reported.
Gastrointestinal side effects including abdominal discomfort, dysphagia, nausea, vomiting, ischemic colitis with rectal bleeding, xerostomia, and diarrhea have been reported. Two cases have been reported by Mayo Clinic researchers documenting the association between use of sumatriptan (the active ingredient contained in Sumavel DosePro) and mesenteric ischemia (a condition characterized by acute cramping, abdominal pain, and bloody diarrhea).
Patients receiving sumatriptan should discontinue the use of the medication and consult with their physician immediately if they experience abdominal pain with bloody diarrhea.
Endocrine side effects have been suggested in one study which reported that sumatriptan (the active ingredient contained in Sumavel DosePro) may increase the secretion of growth hormone by the anterior pituitary.
Dermatologic side effects including exacerbation of sunburn and photosensitivity have been reported.
Other side effects including dysphasia, xerostomia, angioneurotic edema, cyanosis, temporal arteritis, deafness, and death have been reported.
Musculoskeletal side effects including muscle cramps have been reported frequently.
Genitourinary side effects including acute renal failure have been reported.
Psychiatric side effects including panic disorder have been reported.
Respiratory side effects including bronchospasm have been reported.
More Sumavel DosePro resources
- Sumavel DosePro MedFacts Consumer Leaflet (Wolters Kluwer)
- Sumavel DosePro Advanced Consumer (Micromedex) - Includes Dosage Information
- Sumavel DosePro Consumer Overview
- Alsuma Prescribing Information (FDA)
- Alsuma Advanced Consumer (Micromedex) - Includes Dosage Information
- Alsuma Consumer Overview
- Imitrex Consumer Overview
- Imitrex Prescribing Information (FDA)
- Imitrex Monograph (AHFS DI)
- Imitrex MedFacts Consumer Leaflet (Wolters Kluwer)
- Sumatriptan Prescribing Information (FDA)
- Sumatriptan Professional Patient Advice (Wolters Kluwer)
- Sumavel Dosepro Prescribing Information (FDA)
- sumatriptan Advanced Consumer (Micromedex) - Includes Dosage Information
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