"Jan. 15, 2013 -- Women who have migraine with aura may have a higher risk of heart attacks, and they may face a higher risk of dangerous blood clots if they use certain hormonal contraceptives.
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Sumavel DosePro Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Sumavel DosePro (sumatriptan) Injection is used to treat migraines and cluster headaches. It belongs to a group of drugs called triptans. Common side effects include pain, selling or bruising at the injection site; flushing; sensations of tingling/numbness/prickling/heat; weakness; drowsiness; or dizziness.
This medication can be injected by using a syringe and needle, with an auto-injector, or with a needle-free device. The recommended dosage is a single 6-mg subcutaneous injection by self-administration to the abdomen or thigh. Inject Sumavel DosePro just below the skin as soon as migraine/headache symptoms appear. Before injecting each dose with a syringe and needle or an auto-injector, clean the injection site with rubbing alcohol. If using a needle-free device, your skin should be clean and dry before injecting. The drug is available in a form that may be taken by mouth starting 2 hours after the initial injection, if necessary. Sumavel DosePro should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Consult your doctor before using Sumavel DosePro if you are breastfeeding.
Our Sumavel DosePro (sumatriptan) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Sumavel DosePro in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor if you have a serious side effect such as:
- feeling of pain or tightness in your jaw, neck, or throat;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden and severe stomach pain and bloody diarrhea;
- seizure (convulsions);
- numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
- (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Less serious side effects may include:
- mild headache (not a migraine);
- pressure or heavy feeling in any part of your body;
- discomfort in your nose or throat;
- dizziness, spinning sensation;
- muscle pain, neck pain or stiffness;
- warmth, redness, or mild tingling under your skin; or
- pain, redness, bleeding, swelling, or bruising where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Sumavel DosePro (Sumatriptan Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Sumavel DosePro Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Chest/jaw/neck tightness can commonly occur shortly after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes, seizures.
This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., rizatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Sumavel DosePro (Sumatriptan Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sumavel DosePro FDA Prescribing Information: Side Effects
This section provides a summary of adverse reactions reported in subjects in clinical studies conducted with Sumavel DosePro and sumatriptan injection.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
Serious cardiac reactions, including myocardial infarction, have occurred following the use of sumatriptan. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
The following other adverse reactions are discussed in more detail in other sections of labeling:
Sensations of Chest Pain and Tightness [see WARNINGS AND PRECAUTIONS]
Other Vasospasm related Events including Peripheral Vascular Ischemia and Colonic Ischemia [see WARNINGS AND PRECAUTIONS]
Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
Among patients in clinical trials of subcutaneous sumatriptan succinate injection (n=6,218), up to 3.5% of patients withdrew for reasons related to adverse reactions.
Controlled Clinical Trials in Patients with Migraine Headache
Table 1 lists adverse reactions that occurred in 2 large placebo-controlled clinical trials in migraine patients following either a single 6 mg sumatriptan injection or placebo. Only adverse reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and occurred at a frequency greater than in the placebo group are included in Table 1.
Table 1: Treatment-Emergent Adverse Reactions Incidence in
2 Large, Placebo-Controlled Clinical Trials in Patients with Migraine: Events
Reported by at Least 2% of Patients Treated with Sumatriptan Injection 6 mg*
|Adverse Reactions||Percent of Patients Reporting|
|Sumatriptan Injection, 6 mg SC
(n = 547)
|Placebo Injection, SC
(n = 370)
|Burning sensation||7||< 1|
|Feeling of heaviness||7||1|
|Feeling of tightness||5||< 1|
|Feeling strange||2||< 1|
|Tight feeling in head||2||< 1|
|Tightness in chest||3||< 1|
|Discomfort: nasal cavity/sinuses||2||< 1|
|Injection site reaction||59||24|
|Neck pain/stiffness||5||< 1|
|* The sum of the percentages cited is greater than 100% because patients could have experienced more than 1 type of adverse event. Only events that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and that occurred at a frequency greater than that in the placebo group are included.|
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.
Controlled Clinical Trials in Patients with Cluster Headache
In the controlled clinical trials assessing sumatriptan injection as a treatment for cluster headache, no new significant adverse reactions associated with the use of sumatriptan were detected that had not already been identified in association with the drug's use in migraine.
Overall, the frequency of adverse events reported in studies of cluster headache was generally lower. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).
Other Adverse Reactions Observed in Association with the Administration of Sumatriptan Injection
The frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan injection in their causation cannot be reliably determined. Furthermore, variability associated with adverse reactions reporting, the terminology used to describe adverse reactions limits the value of the quantitative frequency estimates provided.
Adverse reactions frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N = 6,218) exposed to subcutaneous sumatriptan. All reported adverse reactions 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. Adverse reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those occurring in at least 1/100 patients, infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients, and rare adverse reactions are those occurring in fewer than 1/1,000 patients.
Cardiovascular: Infrequent were 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, non-sustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle), and syncope. Rare were pallor, arrhythmia, abnormal pulse, vasodilation, and Raynaud syndrome.
Eye: Frequent were vision alterations. Infrequent was irritation of the eye.
Musculoskeletal: Frequent were muscle cramps. Infrequent were various joint disturbances (pain, stiffness, swelling, ache). Rare were muscle stiffness, need to flex calf muscles, backache, muscle tiredness, and swelling of the extremities.
Neurological: Frequent was anxiety. Infrequent were mental confusion, euphoria, agitation, relaxation, chills, sensation of lightness, tremor, shivering, disturbances of taste, prickling sensations, paresthesia, stinging sensations, facial pain, photophobia, and lacrimation. Rare were transient hemiplegia, hysteria, globus hystericus, intoxication, depression, myoclonia, monoplegia/diplegia, sleep disturbance, difficulties in concentration, disturbances of smell, hyperesthesia, dysesthesia, simultaneous hot and cold sensations, tickling sensations, dysarthria, yawning, reduced appetite, hunger, and dystonia.
Urogenital: Rare were dysuria, frequency, dysmenorrhea, and renal calculus.
Miscellaneous: Infrequent were miscellaneous laboratory abnormalities, including minor disturbances in liver function tests, "serotonin agonist effect,” and hypersensitivity to various agents. Rare was fever.
Other Adverse Reactions Observed in the Clinical Development of Sumatriptan
The following adverse reactions occurred in clinical trials with sumatriptan tablets and sumatriptan nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan 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.
Cardiovascular: Abdominal aortic aneurysm, angina, atherosclerosis, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, phlebitis, thrombosis, and transient myocardial ischemia.
Ear, Nose, and Throat: Allergic rhinitis; disorder of nasal cavity/sinuses; ear, nose, and throat hemorrhage; ear infection; external otitis; feeling of fullness in the ear(s); hearing disturbances; hearing loss; Meniere disease; nasal inflammation; otalgia; sensitivity to noise; sinusitis; tinnitus; and upper respiratory inflammation.
Endocrine and Metabolic: Elevated thyrotropin stimulating hormone (TSH) levels; endocrine cysts, lumps, and masses; fluid disturbances; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; weight gain; and weight loss.
Eye: Accommodation disorders, blindness and low vision, conjunctivitis, disorders of sclera, external ocular muscle disorders, eye edema and swelling, eye hemorrhage, eye itching, eye pain, keratitis, mydriasis, and visual disturbances.
Gastrointestinal: Abdominal distention, colitis, constipation, dental pain, dyspeptic symptoms, feelings of gastrointestinal pressure, gastric symptoms, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, melena, nausea and/or vomiting, oral itching and irritation, pancreatitis, salivary gland swelling, and swallowing disorders.
Hematological Disorders: Anemia.
Musculoskeletal: Acquired musculoskeletal deformity, arthralgia and articular rheumatitis, arthritis, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, and tetany.
Neurological: Apathy, aggressiveness, bad/unusual taste, bradylogia, cluster headache, convulsions, depressive disorders, detachment, disturbance of emotions, drug abuse, facial paralysis, hallucinations, heat sensitivity, incoordination, increased alertness, memory disturbance, migraine, motor dysfunction, neoplasm of pituitary, neuralgia, neurotic disorders, paralysis, personality change, phobia, phonophobia, psychomotor disorders, radiculopathy, raised intracranial pressure, rigidity, stress, syncope, suicide, and twitching.
Urogenital: Abnormal menstrual cycle, abortion, bladder inflammation, endometriosis, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, menstruation symptoms, micturition disorders, urethritis, and urinary infections.
Miscellaneous: Contusions, difficulty in walking, edema, hematoma, hypersensitivity, fever, fluid retention, lymphadenopathy, overdose, speech disturbance, swelling of extremities, swelling of face, and voice disturbances.
Pain and Other Pressure Sensations: Chest pain and/or heaviness, neck/throat/jaw pain/tightness/pressure, and pain (location specified).
Clinical Studies Using Sumavel DosePro
Four clinical trials compared the safety and tolerability of Sumavel DosePro (n = 243 administrations) and sumatriptan injection (n = 217 injections) in 120 adult healthy subjects. Local site reactions were prospectively recorded in these trials. There was a higher incidence of bleeding, swelling, erythema, and bruising initially with Sumavel DosePro than with sumatriptan needle based injection (see Table 2). Bleeding was considered minor in all cases, and did not require medical intervention. Most injection site reactions resolved spontaneously, with no apparent difference between Sumavel DosePro and sumatriptan needle injection for bleeding and bruising at 8-hrs post dose, and for swelling and erythema at 24-hrs post dose. No injection site reactions were reported as adverse reactions, and no subject discontinued the studies due to an injection site reaction or adverse reaction in these trials.
Table 2: Incidence of Local Site Reactions in Sumavel DosePro
|Sumavel DosePro (n = 243 injections)||Sumatriptan Injection (n = 217 injections)|
|1 hour post-injection||7%||0%|
|8 hours post-injection||0%||0%|
|24 hours post-injection||0%||0%|
|1 hour post-injection||72%||15%|
|8 hours post-injection||6%||0%|
|24 hours post-injection||1%||1%|
|1 hour post-injection||53%||25%|
|8 hours post-injection||20%||4%|
|24 hours post-injection||9%||3%|
|1 hour post-injection||3%||3%|
|8 hours post-injection||3%||5%|
|24 hours post-injection||5%||6%|
Administration site pain was reported as an adverse event in 2% of administrations in patients after delivery of Sumavel DosePro, compared to 1% after administration of sumatriptan needle injection.
Reports for Subcutaneous or Oral Sumatriptan
The following adverse reactions have been identified during post-approval use of sumatriptan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. However, systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.
Ear, Nose, and Throat: Deafness.
Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision.
Hepatic: Elevated liver function tests.
Psychiatry: Panic disorder.
Respiratory: Bronchospasm in patients with and without a history of asthma.
Skin: Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported [see WARNINGS AND PRECAUTIONS]), photosensitivity. Following subcutaneous administration of sumatriptan, pain, redness, stinging, induration, swelling, contusion, subcutaneous bleeding, and, on rare occasions, lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) has been reported.
Urogenital: Acute renal failure.
Read the entire FDA prescribing information for Sumavel DosePro (Sumatriptan Injection) »
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