Independent reference site — Not affiliated with the U.S. Food and Drug Administration. All data sourced from public FDA databases.
Histamine-2 Receptor Antagonist · Brand: Ranitidine Cool Mint, Acid Reducer

Ranitidine Side Effects: Common, Serious & FDA Warnings

Verified from FDA on Refreshes every 6 hoursFDA-Sourced
FDA-Approved For
Quick answer

Based on 230,000+ FDA adverse event reports, the most-reported ranitidine reactions include breast cancer, prostate cancer, and colorectal cancer. FDA reports 3 active Class II recalls of ranitidine, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Ranitidine

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for ranitidine. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

ReactionReports% of total
Breast Cancer29,41312.8%
Prostate Cancer26,44611.5%
Colorectal Cancer20,7209.0%
Bladder Cancer19,2078.3%
Renal Cancer19,0358.3%
Oesophageal Carcinoma11,0664.8%
Incorrect Dose Administered9,7424.2%
Gastric Cancer8,7423.8%
Hepatic Cancer8,8343.8%
Pancreatic Carcinoma8,0373.5%
Source: FDA FAERS·Updated ·n=230,511+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flagReports% of total
Serious reports (any flag)——
Hospitalization——

Ranitidine Recalls

FDA enforcement actions matched to ranitidine via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

DateReasonClassQuantityStatus
2020-01-08CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Granules India Limited
Class II23,090,000 tabletsOngoing
2019-12-18CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Amneal Pharmaceuticals, Inc.
Class IIN/AOngoing
2019-12-18CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Amneal Pharmaceuticals, Inc.
Class IIN/AOngoing
Source: FDA Drug Enforcement Reports·Updated ·Refreshes every 6 hours·verify on FDA →
Show 4 closed recalls (2019 to 2019)

Includes resolved and terminated recalls matched to ranitidine. Most recent first.

DateReasonClassQuantityStatus
2019-11-13CGMP Deviations: Presence of NDMA impurity detected in product.
Dr. Reddy's Laboratories, Inc.
Class IIN/AResolved
2019-11-13CGMP Deviations: Presence of NDMA impurity detected in product.
Dr. Reddy's Laboratories, Inc.
Class IIN/AResolved
2019-11-13CGMP Deviations: Presence of NDMA impurity detected in product.
Dr. Reddy's Laboratories, Inc.
Class IIN/AResolved
2019-11-13CGMP Deviations: Presence of NDMA impurity detected in product.
Dr. Reddy's Laboratories, Inc.
Class IIN/AResolved

Ranitidine Shortages

FDA-listed shortages of ranitidine products. Strength and dosage-form level detail.

No active or recent shortages of ranitidine are listed. We refresh this view daily.
Source: FDA Drug Shortages·Updated

Is Ranitidine Safe?

Ranitidine is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (ranitidine label)·Updated

FDA-Approved Indications

Ranitidine is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Use(s) relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
Source: DailyMed (ranitidine label)·Updated ·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of ranitidine?
Breast cancer, prostate cancer, and colorectal cancer are among the most-reported reactions in FDA FAERS data for ranitidine. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is ranitidine the same as Ranitidine Cool Mint?
Ranitidine is the generic name; Ranitidine Cool Mint is a brand name for the same active ingredient. Other brand names include Acid Reducer. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has ranitidine been recalled?
Yes. Ranitidine has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are ranitidine's current ongoing recalls about?
Active ranitidine recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is CGMP deviations. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

SourceEndpointRefresh
FAERS reactionsopenFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports.Daily
RecallsopenFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.6 hours
ShortagesFDA Drug Shortages list.Daily
Boxed warnings & label sectionsopenFDA /drug/label.json. Labels are stable; monthly cadence is sufficient.Monthly
Condition categoriesSynonym-mapped from drug_labels.indications. Methodology at /methodology/.Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.