Pharmacologic class (EPC) · 47 drug pages
Nonsteroidal anti-inflammatory drug: adverse event reports filed with FDA
548,672 reports list a drug in this class as a suspect or interacting product, 2004–2026.
- 548,672
- reports across the class
- 2.7% of all reports
- 37,153
- reports, 12 months to June 2026
- 43,790 in the 12 months before
- 71.8%
- marked serious by the reporter
- 57.4% across all reports
- 47
- drugs with a page
- brand and generic names counted separately
Nonsteroidal anti-inflammatory drug is a pharmacologic class (an FDA Established Pharmacologic Class) with 47 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 548,672 adverse event reports received by FDA, 2.7% of the database, from January 2004 to June 2026.
37,153 reports arrived in the 12 months to June 2026, down 15% from 43,790 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 71.8% of the class's reports are marked serious, 16.2% record death among the outcomes and 35.6% record hospitalisation, as reported.
Across the class the reactions recorded most often are drug ineffective (14.8%), off label use (7.6%) and pain (7.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.
The members table is 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."
Drugs in the class
| Drug | Name type | Reports | Latest 12 months | Marked serious | Top term recorded |
|---|---|---|---|---|---|
| Acetaminophen | generic | 86,936 | 11,554 | 94.8% | Toxicity to various agents |
| Ibuprofen | generic | 77,058 | 5,632 | 82.8% | Drug ineffective |
| Aspirin | generic | 72,158 | 3,575 | 93.2% | Gastrointestinal haemorrhage |
| Diclofenac sodium | generic | 51,920 | 2,979 | 51.8% | Drug ineffective |
| AleveNaproxen sodium | brand | 49,101 | 351 | 16.4% | Drug ineffective |
| CelebrexCelecoxib | brand | 45,731 | 735 | 72.2% | Drug ineffective |
| Diclofenac | generic | 27,760 | 2,842 | 91.6% | Drug ineffective |
| Naproxen | generic | 23,872 | 2,147 | 90.7% | Drug ineffective |
| AdvilIbuprofen | brand | 19,649 | 522 | 27.6% | Drug ineffective |
| Celecoxib | generic | 15,201 | 1,925 | 82% | Drug ineffective |
| Naproxen sodium | generic | 9,874 | 1,220 | 79% | Drug ineffective |
| Meloxicam | generic | 7,860 | 459 | 73.1% | Drug ineffective |
| Diclofenac potassium | generic | 5,702 | 1,240 | 97.8% | Rheumatoid arthritis |
| Ketoprofen | generic | 5,639 | 661 | 98.3% | Pain |
| Advil pm | generic | 4,978 | 134 | 11.1% | Drug ineffective |
| MotrinIbuprofen and diphenhydramine citrate | brand | 4,658 | 91 | 50.2% | Drug hypersensitivity |
| Indomethacin | generic | 4,531 | 275 | 89.1% | Drug ineffective |
| Bayer Low DoseAspirin | brand | 3,806 | 40 | 86.2% | Gastrointestinal haemorrhage |
| FlectorDiclofenac epolamine | brand | 2,659 | 12 | 22.2% | Drug ineffective |
| Advil Liqui-GelsIbuprofen | brand | 2,635 | 34 | 19.6% | Drug ineffective |
| Advil Dual Action with AcetaminophenIbuprofen, acetaminophen | brand | 2,156 | 39 | 1% | Product use in unapproved indication |
| Childrens MotrinIbuprofen | brand | 1,927 | 198 | 33.6% | Off label use |
| Piroxicam | generic | 1,742 | 130 | 87.6% | Drug hypersensitivity |
| Bayer aspirin extra strength | generic | 1,567 | 3 | 78.2% | Gastrointestinal haemorrhage |
| Motrin IBIbuprofen | brand | 1,494 | 28 | 26.5% | Drug ineffective |
| CambiaDiclofenac potassium | brand | 1,399 | 7 | 21.8% | Drug ineffective |
| Etodolac | generic | 1,045 | 22 | 75.9% | Drug hypersensitivity |
| IndocinIndomethacin | brand | 1,021 | 1 | 69.5% | Drug hypersensitivity |
| IlevroNepafenac | brand | 1,020 | 5 | 13.5% | Eye pain |
| NevanacNepafenac | brand | 1,003 | 15 | 43.9% | Treatment failure |
| Advil Sinus Congestion And PainIbuprofen, phenylephrine hydrochloride | brand | 983 | 3 | 1% | Product use in unapproved indication |
| Advil Cold And SinusIbuprofen and pseudoephedrine hydrochloride | brand | 919 | 10 | 19.6% | Drug ineffective |
| Diclofenac sodium gel | generic | 919 | 0 | 0.3% | Off label use |
| Mefenamic acid | generic | 866 | 67 | 97.5% | Drug ineffective |
| Nabumetone | generic | 844 | 21 | 59% | Drug hypersensitivity |
| TreximetSumatriptan succinate and naproxen sodium | brand | 830 | 3 | 22% | Drug ineffective |
| EcotrinAspirin | brand | 828 | 4 | 96.5% | Gastrointestinal haemorrhage |
| Bayer genuine aspirin | generic | 811 | 0 | 72.9% | Product use issue |
| Childrens AdvilIbuprofen | brand | 735 | 4 | 21.8% | Drug ineffective |
| Ibuprofen tablets | generic | 690 | 0 | 95.2% | Renal failure acute |
| Bromfenac | generic | 673 | 39 | 12.6% | Treatment failure |
| VoltarenDiclofenac sodium | brand | 653 | 0 | 94% | Drug administered at inappropriate site |
| Aleve Back and Muscle PainNaproxen sodium | brand | 613 | 24 | 9% | Drug ineffective |
| Flurbiprofen | generic | 565 | 55 | 94.9% | Angioedema |
| Advil Dual Action with Acetaminophen Back PainIbuprofen, acetaminophen | brand | 561 | 16 | 0.4% | Product use in unapproved indication |
| Advil MigraineIbuprofen | brand | 556 | 6 | 4.7% | Drug ineffective |
| Motrin InfantsIbuprofen | brand | 524 | 25 | 19.7% | Incorrect dose administered |
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
- Drug ineffectivethe medicine did not work as expected14.8%81,011
- Off label useused for a purpose or in a way not on the label7.6%41,433
- Painpain, site not specified7.5%41,345
- Fatiguetiredness6.6%36,419
- Nauseafeeling sick6.2%33,903
- Drug hypersensitivityan allergic-type reaction to a medicine6.2%33,849
- Rashskin rash6.1%33,624
- Vomitingbeing sick6%32,892
- Headachehead pain5.6%30,595
- Arthralgiajoint pain5.5%30,171
- Abdominal discomfortstomach discomfort5.3%28,954
- Dyspnoeashortness of breath5.3%28,918
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease5.2%28,406
- Product use in unapproved indicationused for a purpose not on the label5.1%27,909
- Hypersensitivityan allergic-type reaction4.9%27,031
- Condition aggravatedthe condition being treated got worse4.7%25,819
- Joint swellinga swollen joint4.7%25,727
- Dizzinesslight-headedness or unsteadiness4.6%25,226
- Diarrhoealoose or frequent stools4.5%24,954
- Drug intolerancethe medicine was not tolerated4.4%24,270
- Product use issuea problem in how the product was used4.3%23,809
- Swellingswelling4.3%23,365
- Toxicity to various agentspoisoning or toxic effect of one or more substances4.2%23,120
- Malaisegeneral feeling of being unwell4.2%22,947
- Pyrexiafever4.1%22,656
Solid bar: share of all class reports. Hollow bar: the median share across the 47 member drugs, the reference used on each member's page. One report can record several terms.
Outcomes, patients and reporters
Outcomes recorded
Patient age
Who reported
Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.
Questions about Nonsteroidal anti-inflammatory drug reports
Which drugs are in the Nonsteroidal anti-inflammatory drug class on this site?
Acetaminophen, Ibuprofen, Aspirin, Diclofenac sodium, Aleve and Celebrex and 41 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.
How many reports does the class have?
548,672 reports through June 2026, 37,153 of them in the latest 12 months. A report listing two drugs of the class counts once for each.
What reactions are recorded most often?
drug ineffective (14.8%), off label use (7.6%), pain (7.5%), fatigue (6.6%) and nausea (6.2%).
Can the members table be used to rank the drugs?
No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.
How do I report an adverse event?
Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.