Sumavel DosePro
- Generic Name: sumatriptan injection
- Brand Name: Sumavel DosePro
Sumavel DosePro (Sumatriptan Injection) side effects drug center
Sumavel DosePro Side Effects Center
What Is Sumavel DosePro?
Sumavel DosePro (sumatriptan) Injection is a triptan used to treat migraines and cluster headaches.
What Are Side Effects of Sumavel DosePro?
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.
Dosage for Sumavel DosePro
The recommended dosage of Sumavel DosePro is a single 6-mg subcutaneous injection by self-administration to the abdomen or thigh.
What Drugs, Substances, or Supplements Interact with Sumavel DosePro?
Sumavel DosePro may interact with other migraine headache medicines, or antidepressants. Tell your doctor all medications and supplements you use.
Sumavel DosePro During Pregnancy and Breastfeeding
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.
Additional Information
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.
Sumavel DosePro Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor at once if you have:
- sudden and severe stomach pain and bloody diarrhea;
- severe chest pain, shortness of breath, irregular heartbeats;
- a seizure (convulsions);
- blood circulation problems in your legs or feet--cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common side effects may include:
- numbness, tingling, warmth, redness, or burning sensation;
- pressure or heavy feeling in any part of your body;
- dizziness, drowsiness, feeling weak or tired;
- neck pain or stiffness; or
- pain or redness where the medicine was injected.
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:
- 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.
Migraine Headache
Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in patients with migraine [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 Patients and at a Greater Frequency Than Placebo in 2 Placebo-Controlled Migraine Clinical Trialsa
| Adverse Reaction | 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 |
| 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 of 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.
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 patients 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).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, or sumatriptan injection. 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.
Cardiovascular
Hypotension, palpitations.
Neurological
Dystonia, tremor.
Read the entire FDA prescribing information for Sumavel DosePro (Sumatriptan Injection)
&Copy; 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.