Drug Safety Information for ZEGERID (Omeprazole; sodium bicarbonate)

Safety-related Labeling Changes for ZEGERID OTC (OMEPRAZOLE; SODIUM BICARBONATE) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for ZEGERID * (Omeprazole; sodium bicarbonate)

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 ZEGERID
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective126
8Incorrect drug administration duration64
12Abdominal pain55
13Abdominal pain upper*54
17Off label use43
18Gastrooesophageal reflux disease43
19Pain in extremity41
20Weight decreased41

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

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

Reason # of FDA Reports
1Gastrooesophageal reflux disease*1066
2Product used for unknown indication729
5Gastric disorder54
6Abdominal pain upper41
7Oesophageal disorder38
8Ill-defined disorder33

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

Types of Adverse Events for ZEGERID

Total Reports Filed with FDA: 6561

Number of FDA Adverse Event Reports by Patient Age for ZEGERID

Total Reports Filed with FDA: 6561*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Omeprazole; sodium bicarbonate (Zegerid)

Charts are based on 6561 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 ZEGERID 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.

Visit   DrugInformer.com more on ZEGERID 's side effects.