Tecentriq: adverse event reports filed with FDA

16,957

reports as suspect product

0.1% of all reports · about 1,683 a year

2,349

reports, 12 months to June 2026

2,568 in the 12 months before

93.5%

marked serious by the reporter

89.9% across the class

32.3%

record death among outcomes, as reported

5,472 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 Tecentriq reports recording the termmedian drug in programmed death receptor-1 blocking antibody

1. Deaththe patient died; cause not stated by this term16.6%2,817
2. Off label useused for a purpose or in a way not on the label8.1%1,379
3. Disease progressionthe disease advanced6.7%1,143
4. Pyrexiafever3.6%618
5. Interstitial lung diseasescarring or inflammation of lung tissue3.2%540
6. Diarrhoealoose or frequent stools2.5%429
7. Fatiguetiredness2.4%413
8. Astheniaweakness or lack of energy2.2%376
9. No adverse eventno adverse event was reported2.1%349
10. Dyspnoeashortness of breath2%333
11. Decreased appetitereduced appetite2%331
12. Pneumonialung infection2%331
13. Rashskin rash2%331
14. Intentional product use issuedeliberate use not as intended1.9%324
15. Hepatic function abnormal1.8%307
16. Ascitesfluid in the abdomen1.7%281
17. Hypothyroidismunderactive thyroid1.7%280
18. Liver disorder1.6%276
19. Drug ineffectivethe medicine did not work as expected1.6%270
20. Febrile neutropeniafever with low white blood cells1.6%269
21. Platelet count decreasedlow platelet count1.5%261
22. Hypertensionhigh blood pressure1.5%247
23. Nauseafeeling sick1.4%243
24. Anaemialow red blood cells1.4%234
25. Malaisegeneral feeling of being unwell1.4%231
26. Proteinuriaprotein in the urine1.3%225
27. Adrenal insufficiencythe adrenal glands produce too little hormone1.3%224
28. Hepatic failureliver failure1.3%218
29. Hepatocellular carcinoma1.2%208
30. Neoplasm malignanta cancer, type not specified1.2%206

Top 30 of 1,193 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. 12.6% 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 16,957 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tecentriq 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 Tecentriq as a suspect or interacting product; reports listing it only as a concomitant medication (236) 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.