Ranitidine hydrochloride: adverse event reports filed with FDA

63,047

reports as suspect product

0.3% of all reports · about 2,803 a year

463

reports, 12 months to June 2026

564 in the 12 months before

97.4%

marked serious by the reporter

96.3% across the class

8.2%

record death among outcomes, as reported

5,194 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 hydrochloride reports recording the termmedian drug in histamine-2 receptor antagonist

1. Breast cancerbreast cancer16.2%10,188
2. Prostate cancer15.3%9,629
3. Colorectal cancer11.4%7,189
4. Renal cancer10.8%6,806
5. Bladder cancer10.7%6,720
6. Oesophageal carcinoma6.1%3,819
7. Hepatic cancer4.8%3,033
8. Gastric cancer4.6%2,878
9. Pancreatic carcinoma4.5%2,809
10. Neoplasm malignanta cancer, type not specified4.4%2,763
11. Lung neoplasm malignantlung cancer4.1%2,557
12. Injurya physical injury2.7%1,728
13. Painpain, site not specified1.9%1,222
14. Off label useused for a purpose or in a way not on the label1.8%1,134
15. Gastrointestinal carcinoma1.6%1,010
16. Thyroid cancer1.5%965
17. Drug ineffectivethe medicine did not work as expected1.5%959
18. Skin cancerskin cancer1.4%858
19. Rashskin rash1.2%738
20. Headachehead pain1.1%716
21. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease1.1%676
22. Uterine cancer1.1%662
23. Product use issuea problem in how the product was used1%646
24. Infusion related reactiona reaction during or soon after an infusion1%629
25. Exposure during pregnancythe medicine was taken during pregnancy1%626
26. Hepatic enzyme increasedraised liver enzymes1%618
27. Joint swellinga swollen joint1%610
28. Hypertensionhigh blood pressure1%609
29. Drug hypersensitivityan allergic-type reaction to a medicine1%605
30. Fatiguetiredness0.9%597

Top 30 of 1,432 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. 94.7% 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 63,047 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ranitidine hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (9,993) 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.