Sumatriptan
Regulatory sources consulted
- openfda-label-eeefceae-7dbe-4215-90b2-59b5d509547f
- AEMPS-CIMA-FT-66406
- ANSM-BDPM-RCP-67876328
- OpenFDA · N02CC01
- AEMPS CIMA · nº registro 66406 ↗
- ANSM BDPM · CIS 67876328 ↗
- RxNorm rxcui 37418 ↗
Approved indications
- Acute treatment of migraine, with or without aura, in adults.
- Acute treatment of cluster headache in adults.
Contraindications
Absolute
- Ischemic heart disease (history of myocardial infarction, Prinzmetal's angina), coronary artery vasospasm.
- History of stroke or transient ischemic attack (TIA); hemiplegic or basilar migraine.
- Peripheral vascular disease, ischemic bowel disease.
- Uncontrolled hypertension.
- Concurrent use (or within 24h) of ergotamine-containing drugs or other 5-HT1 agonists (triptans).
- Concurrent use (or within 2 weeks) of monoamine oxidase (MAO) inhibitors.
- Severe hepatic impairment.
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
Clinical warnings
- Major warning · Risk of myocardial ischemia, myocardial infarction, and Prinzmetal's angina. Perform cardiovascular evaluation in patients with risk factors. — FDA
- Major warning · Sensations of tightness, pain, or pressure in the chest, throat, neck, and/or jaw. If suggestive of ischemia, do not administer further doses and evaluate. — FDA
- Cases of serotonin syndrome have been reported with concomitant use of triptans and SSRIs/SNRIs. — FDA
- Medication overuse headache can occur with prolonged use. — ANSM
Drug interactions
- HighErgotamineN02CA02
Mechanism: Additive vasospastic effects, increasing the risk of coronary ischemia.
Recommendation: Contraindicated. Do not use within 24 hours of each other.
FDA label
- HighMAO-A InhibitorsN06AF
Mechanism: MAO-A inhibitors increase systemic exposure to sumatriptan and the risk of serotonin syndrome.
Recommendation: Contraindicated. Do not use sumatriptan concurrently or within 2 weeks of discontinuing an MAO-A inhibitor.
FDA label
- HighOther 5-HT1 Agonists (Triptans)N02CC
Mechanism: Additive vasospastic effects.
Recommendation: Contraindicated. Do not use within 24 hours of each other.
FDA label
- ModerateSSRIs / SNRIsN06A
Mechanism: Increased risk of serotonin syndrome due to additive serotonergic effects.
Recommendation: Appropriate patient observation is advised if concomitant treatment is clinically warranted.
FDA label
Adverse events
Common (≥1%)
injection site reactions · tingling · dizziness/vertigo · warm/cold sensation · feeling of heaviness · pressure/tightness sensation · flushing · drowsiness
Rare but serious
myocardial infarction · cardiac arrhythmias · stroke · coronary vasospasm · ischemic colitis · seizures · serotonin syndrome · anaphylactic reactions
Pregnancy and lactation
Data from pregnancy exposure registries and epidemiological studies have not detected an increased frequency of birth defects. However, animal studies showed embryolethality and fetal abnormalities. Use only if the potential benefit justifies the potential risk to the fetus.