What the label lists and what reports show
Sumatriptan side effects
Sumatriptan's FDA label: “Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and …” FAERS holds 44,847 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (3,381 reports).
- Generic listed
Check it at the source: the sumatriptan FDA label on DailyMed (effective May 12, 2026, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of sumatriptan tablets?Sumatriptan tablets may cause serious side effects. See “ What is the most important information I should know about sumatriptan tablets? ” These serious side effects include: changes in color or sensation in your fingers and toes (Raynaud’s syndrome) stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: • sudden or severe stomach pain • stomach pain after meals • weight loss • nausea or vomiting • constipation or diarrhea • bloody diarrhea • fever problems with blood circulation to your legs and feet (peripheral vascular ischemia). […]
Source: FDA drug label, Aurobindo Pharma Limited, effective May 12, 2026 (SPL set b2503fff-c978-4efa-b1b4-d7740b6b26f2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue.
Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Tablets and at a Greater Frequency than Placebo
| Reaction | Sumatriptan Tablets 25 mg (n = 417) 5 3 3 | Sumatriptan Tablets 50 mg (n = 771) 6 5 2 | Sumatriptan Tablets 100 mg (n = 437) 6 3 3 | Placebo (n = 309) 4 2 2 |
|---|---|---|---|---|
| Pain and other pressure sensations | 6 | 6 | 8 | 4 |
| Chest - pain/tightness/ pressure and/or heaviness | 1 | 2 | 2 | 1 |
| Neck/throat/jaw - pain/ tightness/pressure | <1 | 2 | 3 | <1 |
| Pain - location specified | 2 | 1 | 1 | 1 |
| Other - pressure/tightness/ heaviness | 1 | 1 | 3 | 2 |
| Neurological Vertigo | <1 | <1 | 2 | <1 |
| Other Malaise/fatigue | 2 | 2 | 3 | <1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] Cerebrovascular events [see Warnings and Precautions (5.4) ] Other vasospasm reactions [see Warnings and Precautions (5.5) ] Medication overuse headache [see Warnings and Precautions (5.6) ] Serotonin syndrome [see Warnings and Precautions (5.7) ] Increase in blood pressure [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Aurobindo Pharma Limited, effective May 12, 2026 (SPL set b2503fff-c978-4efa-b1b4-d7740b6b26f2), via openFDA; the full label on DailyMed
What do FAERS reports show?
44,847 reports list sumatriptan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,094 are coded as a death and 8,335 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sumatriptan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions