DEXILANT FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 969 U.S. reports for DEXILANT (DEXLANSOPRAZOLE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS DEXILANT Report.

Top Adverse Events Reported with DEXILANT (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DIARRHEA	80
2	NAUSEA	69
3	HEADACHE	61
4	FATIGUE	60
5	JOINT PAIN	59
6	DIZZINESS	58
7	PAIN	48
8	VOMITING	43
9	SHORTNESS OF BREATH	42
10	ABDOMINAL PAIN UPPER	41
11	DRUG INEFFECTIVE	41
12	PAIN IN EXTREMITY	37
13	DEATH	35
14	ITCHING	34
15	MUSCLE SPASMS	33
16	PRODUCT SUBSTITUTION ISSUE	33
17	CHEST PAIN	32
18	LACK OF STRENGTH AND ENERGY (ASTHENIA)	31
19	INSOMNIA	30
20	MUSCLE PAIN	29
21	MALAISE	26
22	DEPRESSION	25
23	THERAPY CESSATION	25
24	TREMOR	23
25	BACK PAIN	22

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DEXILANT Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
227	721	21	969

Medwatch Reporter Type	Count
Consumer	391
Physician	30
Pharmacist	136
Other Health Professional	148
Lawyer	1

Top Indications

Gastrooesophageal reflux disease
Product used for unknown indication
INDIGESTION
Barrett's oesophagus
Gastritis erosive

Type of Outcome Reported
Serious: 700
Not Serious: 269
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 969
Concomitant Drugs: 840
Note: A single MedWatch report can list more than one drug. This summary includes DEXILANT identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

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

Have experience (good or bad) with DEXILANT? Rate DEXILANT at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.