Ranitidine: adverse event reports filed with FDA

195,204

reports as suspect product

1% of all reports · about 8,678 a year

269

reports, 12 months to June 2026

617 in the 12 months before

99.1%

marked serious by the reporter

96.3% across the class

6.7%

record death among outcomes, as reported

13,173 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 Ranitidine reports recording the termmedian drug in histamine-2 receptor antagonist

1. Breast cancerbreast cancer18.2%35,607
2. Prostate cancer16.5%32,159
3. Colorectal cancer13.2%25,821
4. Renal cancer12.2%23,815
5. Bladder cancer11.5%22,375
6. Oesophageal carcinoma6.7%13,053
7. Hepatic cancer5.4%10,478
8. Gastric cancer5.3%10,279
9. Lung neoplasm malignantlung cancer4.8%9,446
10. Pancreatic carcinoma4.8%9,409
11. Incorrect dose administeredthe wrong dose was given4.7%9,200
12. Gastrointestinal carcinoma1.7%3,358
13. Thyroid cancer1.7%3,288
14. Neoplasm malignanta cancer, type not specified1.6%3,171
15. Skin cancerskin cancer1.4%2,774
16. Injurya physical injury1.2%2,309
17. Uterine cancer1.2%2,308
18. Ovarian cancer0.9%1,675
19. Drug ineffectivethe medicine did not work as expected0.8%1,509
20. Painpain, site not specified0.7%1,338
21. Brain neoplasm malignant0.7%1,295
22. Testis cancer0.6%1,175
23. Off label useused for a purpose or in a way not on the label0.6%1,166
24. Prostatic disorder0.6%1,133
25. Small intestine carcinoma0.6%1,082
26. Product use in unapproved indicationused for a purpose not on the label0.5%1,072
27. Haematological malignancy0.5%1,058
28. Deaththe patient died; cause not stated by this term0.5%961
29. Cervix carcinoma0.5%959
30. Fatiguetiredness0.5%937

Top 30 of 2,003 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 histamine-2 receptor antagonist 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 270,928 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. 96.3% 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 195,204 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ranitidine 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 histamine-2 receptor antagonist 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 Ranitidine as a suspect or interacting product; reports listing it only as a concomitant medication (55,056) 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.