"The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance"...
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.
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, change in the amount of urine.
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 increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
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
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [see Clinical Studies] following either a single 6 mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1: Adverse Reactions Reported by at Least 2% of
Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled
Migraine Clinical Trialsa
|Adverse Reaction||Percent of Subjects Reporting|
|Sumatriptan Injection 6 mg Subcutaneous
(n = 547)
(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 reactionb||59||24|
|Neck pain/stiffness||5||< 1|
|a The sum of percentages cited is greater than
100% because subjects may have experienced more than 1 type of adverse reaction.
Only reactions that occurred at a frequency of 2% or more in groups treated
with sumatriptan injection and occurred at a frequency greater than that the
placebo group are included.
b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache [see Clinical Studies], no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects with migraine.
Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).
Read the entire FDA prescribing information for Sumavel DosePro (Sumatriptan Injection) »
Additional Sumavel DosePro Information
Sumavel DosePro - User Reviews
Sumavel DosePro User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Find the secrets to longer life.