dexlansoprazole Side Effects
Also known as: Dexilant
Analysis of 40,790 adverse event reports submitted to the FDA from 2008 to 2025.
Total Reports
40,790
Death-Related
3,607
8.8% of reports
Hospitalizations
6,956
17.1% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 3,607 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,827 |
| CHRONIC KIDNEY DISEASE | 1,592 |
| RENAL FAILURE | 1,331 |
| ACUTE KIDNEY INJURY | 1,051 |
| END STAGE RENAL DISEASE | 990 |
| TUBULOINTERSTITIAL NEPHRITIS | 348 |
| RENAL INJURY | 324 |
| OFF LABEL USE | 199 |
| CONDITION AGGRAVATED | 170 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 169 |
| DYSPNOEA | 163 |
| SEPSIS | 162 |
| NAUSEA | 159 |
| ANAEMIA | 156 |
| ABDOMINAL PAIN | 153 |
| DIABETES MELLITUS | 150 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 145 |
| VOMITING | 145 |
| REBOUND ACID HYPERSECRETION | 142 |
| SOMNOLENCE | 142 |
Reactions in Hospitalization Reports
Top reactions in 6,956 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| CHRONIC KIDNEY DISEASE | 945 |
| FATIGUE | 932 |
| ACUTE KIDNEY INJURY | 901 |
| NAUSEA | 796 |
| DYSPNOEA | 759 |
| DRUG INEFFECTIVE | 751 |
| RENAL FAILURE | 738 |
| OFF LABEL USE | 722 |
| HEADACHE | 702 |
| DIARRHOEA | 700 |
| PNEUMONIA | 693 |
| PAIN | 686 |
| ASTHENIA | 524 |
| ABDOMINAL PAIN | 494 |
| COUGH | 489 |
| VOMITING | 480 |
| END STAGE RENAL DISEASE | 472 |
| PYREXIA | 468 |
| DRUG HYPERSENSITIVITY | 465 |
| ARTHRALGIA | 446 |
Nearby — Related Medications
What the FAERS Data Reveals About dexlansoprazole Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 40,790 voluntary reports linked to dexlansoprazole and its brand equivalents (Dexilant), spanning 2008 through 2025. Of those, 3,607 (8.8%) listed death as an outcome and 6,956 (17.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 68% were female and 32% male; age distribution skews toward 45-64, with 7,813 reports in that bracket. The single most reported reaction is chronic kidney disease with 16,100 submissions, followed by acute kidney injury and renal failure.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.