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
1	Drug ineffective	126
2	Nausea*	115
3	Pain	109
4	Fatigue	85
5	Overdose	78
6	Headache*	75
7	Diarrhoea*	68
8	Incorrect drug administration duration	64
9	Dizziness*	63
10	Vomiting*	62
11	Dyspnoea	62
12	Abdominal pain	55
13	Abdominal pain upper*	54
14	Anxiety	52
15	Arthralgia	44
16	Pruritus	44
17	Off label use	43
18	Gastrooesophageal reflux disease	43
19	Pain in extremity	41
20	Weight decreased	41

* 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
1	Gastrooesophageal reflux disease*	1066
2	Product used for unknown indication	729
3	Dyspepsia	211
4	Gastritis	67
5	Gastric disorder	54
6	Abdominal pain upper	41
7	Oesophageal disorder	38
8	Ill-defined disorder	33
9	Excoriation	25
10	Ulcer	24

*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.

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.