Drug Safety Information for ACIPHEX (Rabeprazole sodium)

Safety-related Labeling Changes for ACIPHEX (RABEPRAZOLE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for ACIPHEX SPRINKLE (RABEPRAZOLE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ACIPHEX* (Rabeprazole 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 ACIPHEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*1369
2Diarrhoea*1028
3Dyspnoea958
4Drug ineffective908
5Dizziness*883
6Headache*857
7Fatigue848
8Vomiting848
9Pain835
10Pyrexia794
11Fall725
12Anaemia716
13Pneumonia690
14Malaise676
15Asthenia676
16Decreased appetite630
17Arthralgia628
18Chest pain600
19Rash566
20Weight decreased559

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

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

Reason # of FDA Reports
1Gastrooesophageal reflux disease*9751
2Product used for unknown indication8342
3Prophylaxis2199
4Gastric ulcer*1603
5Prophylaxis against gastrointestinal ulcer1233
6Gastritis*927
7Gastric disorder902
8Dyspepsia*862
9Gastritis prophylaxis455
10Ulcer*359

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


Types of Adverse Events for ACIPHEX

Total Reports Filed with FDA: 104600


Number of FDA Adverse Event Reports by Patient Age for ACIPHEX

Total Reports Filed with FDA: 104600*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rabeprazole sodium (Aciphex sprinkle, Rabeprazole sodium, Rabeprazole, Pariet, Rabeprazole na, Rabeprazol, Aciphex)

Charts are based on 104600 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 ACIPHEX 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.