Indocin: adverse event reports filed with FDA

1,021

reports as suspect product

0% of all reports · about 45 a year

1

reports, 12 months to June 2026

5 in the 12 months before

69.5%

marked serious by the reporter

71.8% across the class

8.8%

record death among outcomes, as reported

90 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 Indocin reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Drug hypersensitivityan allergic-type reaction to a medicine19%194
2. Retinopathy of prematurity5.9%60
3. Drug ineffectivethe medicine did not work as expected3.9%40
4. Intraventricular haemorrhage3.6%37
5. Intraventricular haemorrhage neonatal3.2%33
6. Gastrointestinal haemorrhagebleeding in the stomach or bowel2.9%30
7. Premature babya baby born early2.5%26
8. Dizzinesslight-headedness or unsteadiness2.4%25
9. Necrotising colitis2.4%24
10. Renal failure acute2.3%23
11. Rashskin rash2.2%22
12. Off label useused for a purpose or in a way not on the label2.1%21
13. Necrotising enterocolitis neonatal2%20
14. Drug exposure during pregnancythe medicine was taken during pregnancy1.9%19
15. Headachehead pain1.9%19
16. Bronchopulmonary dysplasia1.7%17
17. Nauseafeeling sick1.7%17
18. Vomitingbeing sick1.7%17
19. Diarrhoealoose or frequent stools1.6%16
20. Sepsisa severe body-wide response to infection1.6%16
21. Deaththe patient died; cause not stated by this term1.4%14
22. Gastrointestinal perforationa hole in the stomach or bowel1.4%14
23. Haemoglobin decreasedlow haemoglobin1.4%14
24. Neonatal respiratory distress syndrome1.4%14
25. Renal failurekidney failure1.4%14
26. Abdominal discomfortstomach discomfort1.3%13
27. Blood creatinine increasedraised creatinine, a kidney test1.3%13
28. Drug interactionan interaction between medicines1.1%11
29. Hypotensionlow blood pressure1.1%11
30. Maternal drugs affecting foetus1.1%11

Top 30 of 267 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 70% 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 1,021 reports.

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 nonsteroidal anti-inflammatory drug 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 Indocin as a suspect or interacting product; reports listing it only as a concomitant medication (1,302) 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.