Drug Safety Information for PROTONIX (Pantoprazole sodium)

Safety-related Labeling Changes for PROTONIX (PANTOPRAZOLE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for PROTONIX IV (PANTOPRAZOLE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for PROTONIX* (Pantoprazole sodium)

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 PROTONIX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*5128
2Dyspnoea4134
3Diarrhoea*3651
4Fatigue3555
5Vomiting3491
6Pain*3393
7Drug ineffective3059
8Asthenia3012
9Dizziness*2795
10Pneumonia2729
11Headache*2708
12Pyrexia2462
13Anaemia2460
14Fall2384
15Abdominal pain2266
16Chest pain2122
17Hypotension2058
18Anxiety*1970
19Weight decreased1924
20Arthralgia*1883

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

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

Reason # of FDA Reports
1Product used for unknown indication43132
2Gastrooesophageal reflux disease*26171
3Prophylaxis5078
4Gastric disorder4535
5Dyspepsia*3011
6Prophylaxis against gastrointestinal ulcer2834
7Gastritis*2519
8Abdominal discomfort*1424
9Gastric ulcer1014
10Ulcer*1010

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


Types of Adverse Events for PROTONIX

Total Reports Filed with FDA: 363729


Number of FDA Adverse Event Reports by Patient Age for PROTONIX

Total Reports Filed with FDA: 363729*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pantoprazole sodium (Pantoprazol, Pantoprazole, Pantoprazole sodium, Protonix, Protonix iv)

Charts are based on 363729 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 PROTONIX 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.