Drugs › Nonsteroidal anti-inflammatory drug
Brand name · Ibuprofen and diphenhydramine citrate
Motrin: adverse event reports filed with FDA
4,658 reports list it as a suspect or interacting product, 2004–2026. Class: Nonsteroidal anti-inflammatory drug. Also reported as Motrin Tab, Motrin Suspension, Motrin /00109201/.
- 4,658
- reports as suspect product
- 0% of all reports · about 207 a year
- 91
- reports, 12 months to June 2026
- 139 in the 12 months before
- 50.2%
- marked serious by the reporter
- 71.8% across the class
- 3.3%
- record death among outcomes, as reported
- 152 reports · not verified by FDA
4,658 adverse event reports received by FDA list the brand name Motrin (ibuprofen and diphenhydramine citrate) as a suspect or interacting product, from January 2004 to June 2026. A further 13,609 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, 91 reports listed it, down 35% from 139 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 207 reports a year and 0% of the 20,646,523 reports in the database, and 0.8% of the reports for the nonsteroidal anti-inflammatory drug class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug hypersensitivity (18.4%), drug ineffective (14.1%) and nausea (11.1%). A report can list several reactions, so shares add to more than 100%; 731 different terms appear across these reports. Drug hypersensitivity is recorded in 18.4% of these reports, a larger share than in the median nonsteroidal anti-inflammatory drug drug (3.7%).
50.2% of the reports are marked serious by the reporter (71.8% across the class); 3.3% record death among the outcomes and 24.8% record hospitalisation, as reported. 59.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (15.2%). 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 Motrin reports recording the termmedian drug in nonsteroidal anti-inflammatory drug
- Drug hypersensitivityan allergic-type reaction to a medicine18.4%856
- Drug ineffectivethe medicine did not work as expected14.1%655
- Nauseafeeling sick11.1%516
- Headachehead pain10.5%489
- Abdominal discomfortstomach discomfort8%372
- Vomitingbeing sick7.9%367
- Dizzinesslight-headedness or unsteadiness6.6%306
- Off label useused for a purpose or in a way not on the label6.5%302
- Decreased appetitereduced appetite6.3%294
- Weight decreasedweight loss5.5%257
- Painpain, site not specified5.3%247
- Abdominal pain upperupper stomach pain4.7%219
- Ear infectionan ear infection4.7%218
- Pharyngitisa sore throat infection4.6%213
- Rashskin rash4.3%201
- Fatiguetiredness4.3%198
- Overdosea dose above the recommended amount3.8%176
- Gastrointestinal pain3.7%171
- Drug intolerancethe medicine was not tolerated3.6%168
- Hypersensitivityan allergic-type reaction3.5%164
- Product use issuea problem in how the product was used3.5%162
- Product use in unapproved indicationused for a purpose not on the label3.4%160
- Gastrointestinal haemorrhagebleeding in the stomach or bowel3.4%158
- Erythemaskin redness3.4%157
- Aspartate aminotransferase increasedraised liver enzyme (AST)3.3%153
- Arthropathy3.2%151
- Enthesopathy3.2%151
- Tenosynovitis3.2%151
- Arthralgiajoint pain3.2%150
- Alanine aminotransferase increasedraised liver enzyme (ALT)3.2%149
Top 30 of 731 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 47 drugs in the nonsteroidal anti-inflammatory drug 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 548,672 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
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. 79.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pain | 355 | 7.6% |
| Rheumatoid arthritis | 214 | 4.6% |
| Pyrexia | 168 | 3.6% |
| Headache | 126 | 2.7% |
| Arthralgia | 91 | 2% |
| Back pain | 79 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 4,658 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Motrin reports |
|---|---|---|
| Ibuprofen | 454 | 9.7% |
| Humira | 418 | 9% |
| Enbrel | 402 | 8.6% |
| Tylenol | 365 | 7.8% |
| Methotrexate | 348 | 7.5% |
| Aspirin | 317 | 6.8% |
| Arava | 299 | 6.4% |
| Naprosyn | 230 | 4.9% |
| Naproxen | 223 | 4.8% |
| Advil | 209 | 4.5% |
Other products listed in reports where Motrin 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
| Measure | Motrin | Nonsteroidal anti-inflammatory drug | All reports |
|---|---|---|---|
| Reports as suspect product | 4,658 | 548,672 | 20,646,523 |
| Share of that pool | — | 0.8% | 0% |
| Reports, latest 12 months | 91 | — | 1,332,454 |
| Marked serious | 50.2% | 71.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 33 | 162 | 91 |
| Hospitalisation recorded, per 1,000 reports | 248 | 356 | 213 |
| Consumer-filed share | 59.8% | 38.7% | 45.8% |
| Top term, share of reports | Drug hypersensitivity 18.4% | median 3.7% | 0.9% |
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 nonsteroidal anti-inflammatory drug class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Acetaminophen | generic | 86,936 | 11,554 | 94.8% |
| Ibuprofen | generic | 77,058 | 5,632 | 82.8% |
| Aspirin | generic | 72,158 | 3,575 | 93.2% |
| Diclofenac sodium | generic | 51,920 | 2,979 | 51.8% |
| Aleve | brand | 49,101 | 351 | 16.4% |
| Celebrex | brand | 45,731 | 735 | 72.2% |
| Diclofenac | generic | 27,760 | 2,842 | 91.6% |
| Naproxen | generic | 23,872 | 2,147 | 90.7% |
| Advil | brand | 19,649 | 522 | 27.6% |
| Celecoxib | generic | 15,201 | 1,925 | 82% |
| Naproxen sodium | generic | 9,874 | 1,220 | 79% |
| Meloxicam | generic | 7,860 | 459 | 73.1% |
| Diclofenac potassium | generic | 5,702 | 1,240 | 97.8% |
| Ketoprofen | generic | 5,639 | 661 | 98.3% |
| Advil pm | generic | 4,978 | 134 | 11.1% |
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.
Questions about Motrin reports
How many adverse event reports has FDA received for Motrin?
4,658 reports list Motrin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 91 of them arrived in the latest 12 months. Another 13,609 list it only as a concomitant medication.
What reactions are recorded in Motrin reports?
drug hypersensitivity (18.4%), drug ineffective (14.1%), nausea (11.1%), headache (10.5%) and abdominal discomfort (8%). 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 Motrin was responsible.
How serious are the reports?
50.2% are marked serious by the reporter. Among the outcomes recorded, 3.3% of reports include death and 24.8% 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?
consumer or non-health professional (59.8%), other health professional (19.9%) and physician (13%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Motrin rising?
91 reports in the 12 months to June 2026, down 35% from 139 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 Motrin 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 Motrin?
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 Motrin as a suspect or interacting product; reports listing it only as a concomitant medication (13,609) 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.