Drug Safety Information for FAMOTIDINE (Famotidine)

Safety-related Labeling Changes for PEPCID (FAMOTIDINE) Rx Drug: FDA Link

Safety-related Labeling Changes for PEPCID AC (FAMOTIDINE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for DUEXIS (FAMOTIDINE; IBUPROFEN) Rx Drug: FDA Link

Adverse Drug Reactions for FAMOTIDINE* (Famotidine)

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 FAMOTIDINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea1684
2Dyspnoea1314
3Pyrexia1298
4Pain*1193
5Vomiting1191
6Diarrhoea1184
7Pneumonia1044
8Fatigue1013
9Dizziness*925
10Anaemia922
11Asthenia913
12Headache*866
13Decreased appetite805
14Drug ineffective785
15Anxiety*774
16Chest pain766
17Fall759
18Abdominal pain745
19Death743
20Platelet count decreased741

* This side effect also appears in "Top 10 Side Effects of FAMOTIDINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking FAMOTIDINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication10591
2Gastrooesophageal reflux disease*5062
3Prophylaxis2901
4Gastritis*2689
5Gastric ulcer1712
6Dyspepsia*1453
7Prophylaxis against gastrointestinal ulcer1359
8Premedication1180
9Gastritis prophylaxis714
10Gastric disorder581

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for FAMOTIDINE

Total Reports Filed with FDA: 143432


Number of FDA Adverse Event Reports by Patient Age for FAMOTIDINE

Total Reports Filed with FDA: 143432*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Famotidine (Mylanta ar, Pepcid ac (geltab), Acid control, Calmicid ac, Heartburn prevention, Heartburn releif, Leader acid reducer, Sunmark acid reducer, Topcare acid reducer, Fluxid, Up and up famotidine, Pepcid ac , Equate famotidine, Acid controller, Pepcid ac, Pepcid rpd, Famotidine, Pepcid)

Charts are based on 143432 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 FAMOTIDINE Reviews and Review Summary .

Historical 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.