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What the label lists and what reports show

Ranitidine side effects

Ranitidine's FDA label lists its adverse reactions in its own words. FAERS holds 230,803 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is breast cancer (29,413 reports).

  • Generic listed

Check it at the source: the ranitidine FDA label on DailyMed (effective May 1, 2026, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following have been reported as events in clinical trials or in the routine management of patients treated with Ranitidine Tablets, USP. The relationship to therapy with Ranitidine Tablets, USP has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine Tablets, USP. Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. …

Source: FDA drug label, Amneal Pharmaceuticals of New York LLC, effective May 1, 2026 (SPL set b38a3332-5c54-453f-aeb7-070f830955c2), via openFDA; the full label on DailyMed

What do FAERS reports show?

230,803 reports list ranitidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17,888 are coded as a death and 29,264 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (116,080, against a median of 8,887 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Breast Cancer29,413
  • Prostate Cancer26,446
  • Colorectal Cancer20,720
  • Bladder Cancer19,207
  • Renal Cancer19,035
  • Oesophageal Carcinoma11,066
  • Incorrect Dose Administered (a use or a product term, not a reaction)9,743
  • Hepatic Cancer8,834
  • Gastric Cancer8,742
  • Pancreatic Carcinoma8,037
  • Lung Neoplasm Malignant7,952
  • Nausea (named in the label)5,479
  • Fatigue5,278
  • Drug Ineffective (a use or a product term, not a reaction)5,149
  • Pain5,062
  • Chronic Kidney Disease4,978
  • Headache (named in the label)4,887
  • Off Label Use (a use or a product term, not a reaction)4,655
  • Dyspnoea4,571
  • Diarrhoea (named in the label)4,561
  • Neoplasm Malignant4,511
  • Vomiting (named in the label)4,086
  • Acute Kidney Injury3,566
  • Dizziness (named in the label)3,460
  • Rash (named in the label)3,311

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ranitidine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions