Caffeine: adverse event reports filed with FDA

3,721

reports as suspect product

0% of all reports · about 165 a year

348

reports, 12 months to June 2026

700 in the 12 months before

92.8%

marked serious by the reporter

45% across the class

55.1%

record death among outcomes, as reported

2,052 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 Caffeine reports recording the termmedian drug in central nervous system stimulant

1. Toxicity to various agentspoisoning or toxic effect of one or more substances32.3%1,201
2. Drug abusemisuse of a medicine11.9%441
3. Overdosea dose above the recommended amount11.7%434
4. Vomitingbeing sick9.3%345
5. Completed suicidedeath by suicide8.4%314
6. Drug interactionan interaction between medicines8.4%312
7. Dyspnoeashortness of breath8%297
8. Painpain, site not specified7.9%295
9. Headachehead pain7.2%268
10. Fatiguetiredness7%259
11. Diarrhoealoose or frequent stools6.9%256
12. Anxietyanxiety6.9%255
13. Arthralgiajoint pain6.8%253
14. Dizzinesslight-headedness or unsteadiness6.5%243
15. Insomniadifficulty sleeping6.5%243
16. Off label useused for a purpose or in a way not on the label6.4%239
17. Malaisegeneral feeling of being unwell6.2%230
18. Nauseafeeling sick6.2%230
19. Arthropathy6.1%226
20. Mobility decreasedreduced ability to move about5.9%221
21. Abdominal discomfortstomach discomfort5.9%219
22. Abdominal pain upperupper stomach pain5.9%218
23. Pruritusitching5.7%213
24. Pneumonialung infection5.6%208
25. Maternal exposure during pregnancythe mother took the medicine during pregnancy5.5%206
26. Depressionlow mood5.5%205
27. Confusional stateconfusion5.5%204
28. Drug hypersensitivityan allergic-type reaction to a medicine5.4%200
29. Rashskin rash5.4%200
30. Abdominal painstomach or belly pain5.2%193

Top 30 of 798 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 26 drugs in the central nervous system stimulant 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 109,804 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. 37.4% 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 3,721 reports.

Drugs most often listed in the same reports

Other products listed in reports where Caffeine 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 central nervous system stimulant 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 Caffeine as a suspect or interacting product; reports listing it only as a concomitant medication (4,003) 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.