Sigma-1 agonist: adverse event reports filed with FDA

4,313

reports across the class

0% of all reports

133

reports, 12 months to June 2026

163 in the 12 months before

56.5%

marked serious by the reporter

57.4% across all reports

3

drugs with a page

brand and generic names counted separately

Drugs in the 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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

1. Toxicity to various agentspoisoning or toxic effect of one or more substances15.6%673
2. Drug abusemisuse of a medicine15.5%670
3. Drug ineffectivethe medicine did not work as expected9.9%428
4. Completed suicidedeath by suicide7.8%336
5. Deaththe patient died; cause not stated by this term5.6%241
6. Off label useused for a purpose or in a way not on the label5.2%225
7. Overdosea dose above the recommended amount4.3%186
8. Drug interactionan interaction between medicines4.3%185
9. Vomitingbeing sick3.8%165
10. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.3%144
11. Incorrect dose administeredthe wrong dose was given3.1%133
12. Cardio-respiratory arrestthe heart and breathing stopped3%131
13. Drug administered to patient of inappropriate age3%131
14. Product use issuea problem in how the product was used3%130
15. Wrong technique in product usage processthe product was used in the wrong way2.9%123
16. Product use in unapproved indicationused for a purpose not on the label2.8%121
17. Intentional overdosea deliberate overdose2.6%112
18. Diarrhoealoose or frequent stools2.5%106
19. Malaisegeneral feeling of being unwell2.5%106
20. Condition aggravatedthe condition being treated got worse2.3%99
21. Dyspnoeashortness of breath2.3%98
22. Dizzinesslight-headedness or unsteadiness2.2%96
23. Product administered to patient of inappropriate age2.2%96
24. Cardiac arrestthe heart stopped2.1%92
25. Accidental overdosean accidental overdose2.1%90

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.