Opdivo: adverse event reports filed with FDA

46,610

reports as suspect product

0.2% of all reports · about 4,055 a year

3,753

reports, 12 months to June 2026

3,967 in the 12 months before

83.6%

marked serious by the reporter

89.9% across the class

28.1%

record death among outcomes, as reported

13,119 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 Opdivo reports recording the termmedian drug in programmed death receptor-1 blocking antibody

1. Deaththe patient died; cause not stated by this term17.4%8,093
2. Malignant neoplasm progression9.7%4,542
3. Off label useused for a purpose or in a way not on the label7.1%3,332
4. Intentional product use issuedeliberate use not as intended5%2,325
5. Diarrhoealoose or frequent stools4.8%2,224
6. Fatiguetiredness3.9%1,834
7. Rashskin rash3.6%1,656
8. Pyrexiafever3.5%1,653
9. Decreased appetitereduced appetite3%1,379
10. Nauseafeeling sick2.7%1,271
11. Adverse eventan unwanted medical event, type not specified2.2%1,046
12. Interstitial lung diseasescarring or inflammation of lung tissue2.2%1,028
13. Dyspnoeashortness of breath2%955
14. Colitisinflamed bowel2%932
15. Malaisegeneral feeling of being unwell2%924
16. Pneumonialung infection1.9%906
17. Pruritusitching1.9%901
18. Hypothyroidismunderactive thyroid1.9%873
19. Product use in unapproved indicationused for a purpose not on the label1.9%865
20. Weight decreasedweight loss1.8%849
21. Astheniaweakness or lack of energy1.6%754
22. Vomitingbeing sick1.6%738
23. Liver disorder1.6%725
24. Arthralgiajoint pain1.5%708
25. Adrenal insufficiencythe adrenal glands produce too little hormone1.5%700
26. Immune-mediated enterocolitis1.5%695
27. Pneumonitis1.5%681
28. Hepatic function abnormal1.4%662
29. Constipationconstipation1.4%638
30. Acute kidney injurysudden loss of kidney function1.2%550

Top 30 of 2,224 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 8 drugs in the programmed death receptor-1 blocking antibody 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 225,959 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. 43.9% 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 46,610 reports.

Drugs most often listed in the same reports

Other products listed in reports where Opdivo 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 programmed death receptor-1 blocking antibody 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 Opdivo as a suspect or interacting product; reports listing it only as a concomitant medication (1,091) 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.