Drug Safety Information for DEXILANT (Dexlansoprazole)

Safety-related Labeling Changes for DEXILANT (DEXLANSOPRAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for DEXILANT SOLUTAB (DEXLANSOPRAZOLE) Discontinued Drug: FDA Link

Adverse Drug Reactions for DEXILANT* (Dexlansoprazole)

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 DEXILANT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*365
2Nausea*335
3Drug ineffective292
4Fatigue282
5Pain*258
6Headache*247
7Dyspnoea242
8Vomiting239
9Dizziness*230
10Arthralgia166
11Abdominal pain165
12Injection site pain164
13Malaise160
14Asthenia149
15Pain in extremity148
16Abdominal pain upper143
17Rash143
18Pruritus*141
19Depression*129
20Chest pain127

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

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

Reason # of FDA Reports
1Gastrooesophageal reflux disease*4829
2Product used for unknown indication2768
3Dyspepsia*462
4Gastric disorder366
5Barrett's oesophagus139
6Ulcer*128
7Gastric ulcer97
8Abdominal discomfort96
9Gastritis*87
10Gastrointestinal disorder82

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


Types of Adverse Events for DEXILANT

Total Reports Filed with FDA: 19875


Number of FDA Adverse Event Reports by Patient Age for DEXILANT

Total Reports Filed with FDA: 19875*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dexlansoprazole (Lansoprazol, Dexilant, Lanzoprazole, Kapidex)

Charts are based on 19875 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 DEXILANT 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.