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Sumavel DosePro

Last reviewed on RxList: 6/13/2016
Sumavel DosePro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/05/2016

Sumavel DosePro (sumatriptan) Injection is a triptan used to treat migraines and cluster headaches. Common side effects of Sumavel DosePro include injection site reactions (pain, swelling, bruising, redness, or bleeding), flushing (warmth, redness, or tingling), sensations of numbness/prickling/heat, weakness, drowsiness, dizziness, spinning sensation, mild headache (not a migraine), pressure or heavy feeling in any part of your body, discomfort in your nose or throat, muscle pain, or neck pain or stiffness.

The recommended dosage of Sumavel DosePro is a single 6-mg subcutaneous injection by self-administration to the abdomen or thigh. Sumavel DosePro may interact with other migraine headache medicines, or antidepressants. Tell your doctor all medications and supplements you use. 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.

Sumavel DosePro Consumer Information

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)

Sumavel DosePro Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

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.

Migraine Headache

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)
Placebo
(n = 370)
Atypical sensations 42 9
  Tingling 14 3
  Warm/hot sensation 11 4
  Burning sensation 7 <1
  Feeling of heaviness 7 1
  Pressure sensation 7 2
  Feeling of tightness 5 <1
  Numbness 5 2
  Feeling strange 2 <1
  Tight feeling in head 2 <1
Cardiovascular    
  Flushing 7 2
  Chest discomfort 5 1
Tightness in chest 3 <1
Discomfort: nasal cavity/sinuses 2 <1
  Injection site reactionb 59 24
  Miscellaneous    
    Jaw discomfort 2 0
  Musculoskeletal    
  Weakness 5 <1
  Neck pain/stiffness 5 <1
  Myalgia 2 <1
  Neurological    
    Dizziness/vertigo 12 4
    Drowsiness/sedation 3 2
    Headache 2 <1
  Skin    
    Sweating 2 1
aThe 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 of the placebo group are included.
bIncludes 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.

Cluster Headache: 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)

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© Sumavel DosePro Patient Information is supplied by Cerner Multum, Inc. and Sumavel DosePro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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