Sumatriptan succinate: adverse event reports filed with FDA

3,580

reports as suspect product

0% of all reports · about 159 a year

365

reports, 12 months to June 2026

234 in the 12 months before

40.8%

marked serious by the reporter

48% across the class

2.6%

record death among outcomes, as reported

92 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Sumatriptan succinate reports recording the termmedian drug in serotonin-1b and serotonin-1d receptor agonist

1. Drug ineffectivethe medicine did not work as expected27.5%984
2. Product quality issuea problem with the product itself13.4%479
3. Product dose omission issuea dose was missed10.1%361
4. Headachehead pain9.9%356
5. Product complaint9.8%351
6. Migrainemigraine9.1%327
7. Device malfunctionthe device did not work properly7.8%279
8. Drug intolerancethe medicine was not tolerated6.5%234
9. Off label useused for a purpose or in a way not on the label6.3%225
10. Nauseafeeling sick6.1%217
11. Hypersensitivityan allergic-type reaction4.9%175
12. Angioedemadeep swelling of skin or mucous membranes4.3%153
13. Dysphoniaa hoarse voice4.2%152
14. Swollen tongue4.2%152
15. Swelling facea swollen face4.1%147
16. Dizzinesslight-headedness or unsteadiness3.8%137
17. Drug ineffective for unapproved indication3.7%134
18. Product use in unapproved indicationused for a purpose not on the label3.5%126
19. Drug hypersensitivityan allergic-type reaction to a medicine3.5%124
20. Somnolencedrowsiness3.2%115
21. Wrong technique in device usage process3.2%113
22. Vomitingbeing sick2.9%105
23. Hypertensionhigh blood pressure2.8%100
24. Product substitution issuea problem after switching products2.7%97
25. Hyperhidrosisexcessive sweating2.6%93
26. Asthmaasthma2.3%83
27. Chest painchest pain2.3%81
28. Depressionlow mood2.2%79
29. Incorrect route of product administrationthe product was given by the wrong route2.2%77
30. Painpain, site not specified2.1%76

Top 30 of 564 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 9 drugs in the serotonin-1b and serotonin-1d receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 27,938 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 72% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,580 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sumatriptan succinate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the serotonin-1b and serotonin-1d receptor agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sumatriptan succinate as a suspect or interacting product; reports listing it only as a concomitant medication (4,207) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.