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
1Nausea*3376
2Drug ineffective3253
3Dyspnoea2938
4Diarrhoea2654
5Vomiting2622
6Pain*2246
7Fatigue2231
8Headache*2087
9Dizziness*2080
10Pyrexia1698
11Asthenia1684
12Chest pain1586
13Abdominal pain1466
14Malaise1428
15Fall1397
16Pneumonia1389
17Anxiety*1382
18Rash1330
19Arthralgia1300
20Depression1293

* 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
1Product used for unknown indication24357
2Gastrooesophageal reflux disease*16226
3Dyspepsia*8796
4Premedication3649
5Prophylaxis3470
6Gastric disorder3059
7Gastritis*2153
8Prophylaxis against gastrointestinal ulcer1242
9Gastric ulcer1094
10Abdominal discomfort1065

*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.

Click to go back to search results and ZANTAC 150 Reviews and Review Summary .

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.

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