Drug Safety Information for PRILOSEC (Omeprazole)

Safety-related Labeling Changes for PRILOSEC (OMEPRAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) Over-the-counter Drug: FDA Link

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

Adverse Drug Reactions for PRILOSEC* (Omeprazole)

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 PRILOSEC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*7662
2Dyspnoea6591
3Diarrhoea6271
4Drug ineffective6089
5Vomiting5647
6Fatigue5597
7Pain*5178
8Dizziness*4855
9Headache*4768
10Asthenia4510
11Pyrexia4151
12Fall3814
13Pneumonia3671
14Malaise3641
15Anaemia3550
16Arthralgia*3508
17Abdominal pain3423
18Chest pain3298
19Drug interaction3270
20Pain in extremity3138

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

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

Reason # of FDA Reports
1Product used for unknown indication66155
2Gastrooesophageal reflux disease*49802
3Dyspepsia*10665
4Gastric disorder8434
5Prophylaxis8080
6Gastritis*5696
7Prophylaxis against gastrointestinal ulcer4920
8Abdominal discomfort*2937
9Gastric ulcer*2459
10Abdominal pain upper*2294

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


Types of Adverse Events for PRILOSEC

Total Reports Filed with FDA: 583110


Number of FDA Adverse Event Reports by Patient Age for PRILOSEC

Total Reports Filed with FDA: 583110*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Omeprazole (Esomeprazole, Care one omeprazole, Dg health omeprazole, Equaline omeprazole, Leader omeprazole, Omesec, Sunmark omeprazole, Topcare omeprazole, Up and up omeprazole, Shoprite omeprazole, Omeprazole, Omeprazole dr, Esomeprazol, Losec, Prilosec)

Charts are based on 583110 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 PRILOSEC 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.