Brand name · Butalbital, acetaminophen and caffeine
Fioricet: adverse event reports filed with FDA
868 reports list it as a suspect or interacting product, 2004–2026. Also reported as Fioricet Tablets.
- 868
- reports as suspect product
- 0% of all reports · about 39 a year
- 42
- reports, 12 months to June 2026
- 52 in the 12 months before
- 66.5%
- marked serious by the reporter
- 57.4% across all reports
- 25%
- record death among outcomes, as reported
- 217 reports · not verified by FDA
868 adverse event reports received by FDA list the brand name Fioricet (butalbital, acetaminophen and caffeine) as a suspect or interacting product, from January 2004 to June 2026. A further 8,071 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 42 reports listed it, down 19% from 52 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 39 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are death (18.7%), drug ineffective (14.2%) and headache (7.7%). A report can list several reactions, so shares add to more than 100%; 325 different terms appear across these reports. Death is recorded in 18.7% of these reports, against 4.1% of all reports in the database.
66.5% of the reports are marked serious by the reporter; 25% record death among the outcomes and 20% record hospitalisation, as reported. 37.4% of the reports came from physicians, and the largest patient age group is 18 to 44 (26%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Fioricet reports recording the termall reports in the database
- Deaththe patient died; cause not stated by this term18.7%162
- Drug ineffectivethe medicine did not work as expected14.2%123
- Headachehead pain7.7%67
- Nauseafeeling sick5.3%46
- Migrainemigraine4.5%39
- Overdosea dose above the recommended amount4.5%39
- Drug dependencedependence on a medicine3.9%34
- Drug hypersensitivityan allergic-type reaction to a medicine3.9%34
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.8%33
- Maternal exposure during pregnancythe mother took the medicine during pregnancy3.8%33
- Painpain, site not specified3.5%30
- Cardio-respiratory arrestthe heart and breathing stopped2.8%24
- Vomitingbeing sick2.8%24
- Depressionlow mood2.3%20
- Exposure during pregnancythe medicine was taken during pregnancy2.2%19
- Feeling abnormalfeeling odd or not right2.2%19
- Somnolencedrowsiness2.2%19
- Metabolic acidosistoo much acid in the body fluids2%17
- Drug abusemisuse of a medicine1.8%16
- Fatiguetiredness1.8%16
- Confusional stateconfusion1.7%15
- Dizzinesslight-headedness or unsteadiness1.7%15
- Drug interactionan interaction between medicines1.7%15
- Paraesthesiatingling or pins and needles1.6%14
- Anxietyanxiety1.5%13
- Insomniadifficulty sleeping1.5%13
- Intentional overdosea deliberate overdose1.3%11
- Treatment failurethe treatment did not work1.3%11
- Falla fall1.2%10
- Hepatotoxicityliver injury1.2%10
Top 30 of 325 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 share of all reports in the database; 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 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 94.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Migraine | 174 | 20% |
| Headache | 93 | 10.7% |
| Pain | 13 | 1.5% |
| Foetal exposure during pregnancy | 6 | 0.7% |
| Back pain | 4 | 0.5% |
| Pyrexia | 4 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 868 reports.
In context
| Measure | Fioricet | All reports |
|---|---|---|
| Reports as suspect product | 868 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 42 | 1,332,454 |
| Marked serious | 66.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 250 | 91 |
| Hospitalisation recorded, per 1,000 reports | 200 | 213 |
| Consumer-filed share | 36.1% | 45.8% |
| Top term, share of reports | Death 18.7% | 4.1% |
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."
Questions about Fioricet reports
How many adverse event reports has FDA received for Fioricet?
868 reports list Fioricet as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 42 of them arrived in the latest 12 months. Another 8,071 list it only as a concomitant medication.
What reactions are recorded in Fioricet reports?
death (18.7%), drug ineffective (14.2%), headache (7.7%), nausea (5.3%) and migraine (4.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Fioricet was responsible.
How serious are the reports?
66.5% are marked serious by the reporter. Among the outcomes recorded, 25% of reports include death and 20% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (37.4%), consumer or non-health professional (36.1%) and other health professional (14.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Fioricet rising?
42 reports in the 12 months to June 2026, down 19% from 52 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Fioricet was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Fioricet?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Fioricet as a suspect or interacting product; reports listing it only as a concomitant medication (8,071) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.