What the label lists and what reports show
Dexlansoprazole side effects
Dexlansoprazole's FDA label: “The most common adverse reactions are: Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.” FAERS holds 41,466 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is chronic kidney disease (16,102 reports).
- Generic listed
Check it at the source: the dexlansoprazole FDA label on DailyMed (effective February 17, 2025, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DEXILANT?DEXILANT may cause serious side effects, including: See " What is the most important information I should know about DEXILANT? ". Vitamin B12 deficiency. DEXILANT reduces the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Talk with your doctor about the possibility of Vitamin B12 deficiency if you have been on DEXILANT for a long time (more than 3 years). Low magnesium levels in your body can happen in people who have taken DEXILANT for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice. Stomach growths (fundic gland polyps). […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective February 17, 2025 (SPL set 9819f033-3bbe-442e-8e92-45fec77b237d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are: Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.
Table 2. Common Adverse Reactions in Controlled Studies in Adults
| Adverse Reaction | Placebo (N=896) % | DEXILANT 30 mg (N=455) % | DEXILANT 60 mg (N=2218) % | DEXILANT Total (N=2621) % | Lansoprazole 30 mg (N=1363) % |
|---|---|---|---|---|---|
| Diarrhea | 2.9 | 5.1 | 4.7 | 4.8 | 3.2 |
| Abdominal Pain | 3.5 | 3.5 | 4.0 | 4.0 | 2.6 |
| Nausea | 2.6 | 3.3 | 2.8 | 2.9 | 1.8 |
| Upper Respiratory Tract Infection | 0.8 | 2.9 | 1.7 | 1.9 | 0.8 |
| Vomiting | 0.8 | 2.2 | 1.4 | 1.6 | 1.1 |
| Flatulence | 0.6 | 2.6 | 1.4 | 1.6 | 1.2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age [see Warnings and Precautions (5.12) ] The most common adverse reactions are: Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. ( 6.1 ) Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective February 17, 2025 (SPL set 9819f033-3bbe-442e-8e92-45fec77b237d), via openFDA; the full label on DailyMed
What do FAERS reports show?
41,466 reports list dexlansoprazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,710 are coded as a death and 7,224 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (13,440, against a median of 1,914 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dexlansoprazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions