Drug Safety Information for ZANTAC 150 (Ranitidine hydrochloride)
Recall for RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) Rx Drug: FDA Link
NDMA contamination voluntary recalls of some products
Safety-related Labeling Changes for ZANTAC 75 (RANITIDINE HYDROCHLORIDE) Over-the-counter Drug: FDA Link
Adverse Drug Reactions for ZANTAC 150* (Ranitidine hydrochloride)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with ZANTAC 150
(reported in FDA Medwatch/FAERS Reports)
|Side Effect||# of FDA Reports|
* This side effect also appears in "Top 10 Side Effects of ZANTAC 150 " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ZANTAC 150
(associated with FDA Medwatch/FAERS Reports)
|Reason||# of FDA Reports|
|1||Product used for unknown indication||24357|
|2||Gastrooesophageal reflux disease*||16226|
|8||Prophylaxis against gastrointestinal ulcer||1242|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ZANTAC 150
Total Reports Filed with FDA: 249193
Number of FDA Adverse Event Reports by Patient Age for ZANTAC 150
Total Reports Filed with FDA: 249193*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ranitidine hydrochloride (Zantac 25, Wal zan 150, Equate acid reducer, Careone acid reducer, Acid relief, Formucare ranitidine, Leader acid control, Major ranitidine, Ranitidina, Wal zan 75, Wal zan acid reducer, Acid reducer 150, Aptidine, Up and up ranitidine, Equate ranitidine, Ranitidine 150, Wal-zan 75, Zantac 75, Wal-zan, Ranitidine 75, Zantac 300, Ranitidine, Zantac, Zantac 150)
Charts are based on 249193 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.