Drug Safety Information for PEPCID AC (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 PEPCID AC* (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 PEPCID AC
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Nausea | 1684 |
2 | Dyspnoea | 1314 |
3 | Pyrexia | 1298 |
4 | Pain* | 1193 |
5 | Vomiting | 1191 |
6 | Diarrhoea | 1184 |
7 | Pneumonia | 1044 |
8 | Fatigue | 1013 |
9 | Dizziness* | 925 |
10 | Anaemia | 922 |
11 | Asthenia | 913 |
12 | Headache* | 866 |
13 | Decreased appetite | 805 |
14 | Drug ineffective | 785 |
15 | Anxiety* | 774 |
16 | Chest pain | 766 |
17 | Fall | 759 |
18 | Abdominal pain | 745 |
19 | Death | 743 |
20 | Platelet count decreased | 741 |
* This side effect also appears in "Top 10 Side Effects of PEPCID AC " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking PEPCID AC
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 10591 |
2 | Gastrooesophageal reflux disease* | 5062 |
3 | Prophylaxis | 2901 |
4 | Gastritis* | 2689 |
5 | Gastric ulcer | 1712 |
6 | Dyspepsia* | 1453 |
7 | Prophylaxis against gastrointestinal ulcer | 1359 |
8 | Premedication | 1180 |
9 | Gastritis prophylaxis | 714 |
10 | Gastric disorder | 581 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for PEPCID AC
Total Reports Filed with FDA: 143432
Number of FDA Adverse Event Reports by Patient Age for PEPCID AC
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 PEPCID AC 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.