Drug · FAERS side-effect profile with label screen
Lansoprazole side effects: what 177,056 FDA adverse event reports show
Who reports
177,056 reports · 87% serious · 19,914 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the: • Treatment of active duodenal ulcer in adults. ( 1.1 ) • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) • Maintenance of healed duodenal ulcers in adults. ( 1.3 ) • Treatment of active benign gastric ulcer in adults.
FDA label, Indications and Usage
What it is
Lansoprazole is a sulfoxide, a member of benzimidazoles and a member of pyridines. It has a role as an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor and an anti-ulcer drug.
PubChem CID 3883 (ChEBI)
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 5Likely indication confounding 3Reporting / coding artifact 3Lab value / disease marker 6Not in label — unassessed 21
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,161 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Renal haemangioma | 790 | 13,077.1 6,213.9–27,520.5ROR 13,135.7 · calibrated p 2e-26 ✓ | 115.5 EB05 108.9 · IC025 +6.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.0–5.9) | Not in label — unassessed | serious n=790 · 100% consumer | not reported in cached trials |
| Appendicolith | 294 | 420.6 328.9–537.8ROR 421.3 · calibrated p 7e-13 ✓ | 91.1 EB05 82.7 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 31.3 (25.8–38.1) | Not in label — unassessed | serious n=294 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Cardiospasm | 404 | 318.5 263.7–384.6ROR 319.2 · calibrated p 8e-12 ✓ | 85.4 EB05 78.6 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.6 (3.2–4.0) | Labeled adverse reaction exact term | serious n=404 | not reported in cached trials |
| Sleep disorder therapy | 123 | 233.6 171.9–317.6ROR 233.8 · calibrated p 2e-10 ✓ | 77.2 EB05 66.4 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 17.3 (13.4–22.3) | Reporting / coding artifact | serious n=123 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Hypertensive nephropathy | 671 | 197.3 174.3–223.5ROR 198.1 · calibrated p 5e-10 ✓ | 73.5 EB05 68.9 · IC025 +6.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.7 (6.1–7.3) | Not in label — unassessed | serious n=671 · 80% consumer | not reported in cached trials |
| Immunisation | 261 | 181.1 149.1–219.9ROR 181.4 · calibrated p 1e-9 ✓ | 70.9 EB05 64.0 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.7 (4.1–5.4) | Not in label — unassessed | serious n=261 | not reported in cached trials |
| Rebound acid hypersecretion | 1,718 | 152.1 141.5–163.4ROR 153.6 · calibrated p 4e-9 ✓ | 66.3 EB05 63.7 · IC025 +5.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.1 (3.9–4.3) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,715 | not reported in cached trials |
| Grip strength | 128 | 146.8 113.1–190.6ROR 147.0 · calibrated p 9e-9 ✓ | 64.7 EB05 55.8 · IC025 +5.4 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=128 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Palmoplantar keratoderma | 393 | 143.2 123.5–166.0ROR 143.5 · calibrated p 8e-9 ✓ | 64.4 EB05 59.2 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.6 (3.2–4.0) | Not in label — unassessed | serious n=393 | not reported in cached trials |
| End stage renal disease | 9,798 | 135.5 131.6–139.4ROR 143.4 · calibrated p 7e-9 ✓ | 63.0 EB05 61.9 · IC025 +5.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.1 (5.0–5.2) | Not in label — unassessed | serious PRR 41.5 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 542 | 120.8 107.1–136.2ROR 121.1 · calibrated p 3e-8 ✓ | 59.5 EB05 55.4 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.4 (4.0–4.8) | Not in label — unassessed | serious n=542 · 100% consumer | not reported in cached trials |
| Nephrogenic anaemia | 2,215 | 107.0 101.0–113.3ROR 108.3 · calibrated p 6e-8 ✓ | 56.1 EB05 54.1 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.5 (4.3–4.7) | Not in label — unassessed | serious n=2,214 · 72% consumer | not reported in cached trials |
| Chronic kidney disease | 32,791 | 88.7 87.5–89.9ROR 108.6 · calibrated p 6e-8 ✓ | 50.7 EB05 50.2 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.8 (4.8–4.8) | Labeled (related wording) related wording | age-adj. PRR 27.8 · serious PRR 33.4 · 70% consumer | not reported in cached trials |
| Analgesic therapy | 124 | 80.3 63.8–100.9ROR 80.3 · calibrated p 8e-7 ✓ | 47.5 EB05 40.9 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 16.3 (12.7–20.9) | Reporting / coding artifact | serious n=124 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 754 | 73.9 67.5–81.0ROR 74.2 · calibrated p 1e-6 ✓ | 45.5 EB05 42.8 · IC025 +5.3 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=754 · ♀ 100% (drug 58%) · 91% clinician | not reported in cached trials |
| Lupus vulgaris | 444 | 70.4 62.6–79.2ROR 70.6 · calibrated p 1e-6 ✓ | 44.1 EB05 40.7 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=444 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 912 | 66.6 61.4–72.2ROR 66.9 · calibrated p 2e-6 ✓ | 42.6 EB05 40.3 · IC025 +5.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.1 (3.9–4.5) | Not in label — unassessed | serious n=912 · 100% consumer | not reported in cached trials |
| C-reactive protein | 324 | 65.6 57.3–75.2ROR 65.8 · calibrated p 2e-6 ✓ | 42.2 EB05 38.4 · IC025 +5.1 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=324 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Drug therapy | 110 | 61.9 49.1–78.0ROR 61.9 · calibrated p 4e-6 ✓ | 40.4 EB05 34.5 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 15.9 (12.2–20.7) | Reporting / coding artifact | serious n=110 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Hyperchlorhydria | 2,028 | 61.2 58.0–64.6ROR 61.9 · calibrated p 3e-6 ✓ | 40.4 EB05 38.9 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.5 (5.3–5.8) | Not in label — unassessed | serious n=1,730 · 92% consumer | not reported in cached trials |
| Subcutaneous drug absorption impaired | 177 | 56.8 47.5–68.0ROR 56.9 · calibrated p 7e-6 ✓ | 38.3 EB05 33.8 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Labeled (related wording) related wording | serious n=176 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Renal injury | 9,519 | 54.9 53.6–56.2ROR 57.9 · calibrated p 5e-6 ✓ | 37.5 EB05 36.9 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.5) | Labeled (related wording) related wording | serious PRR 24.8 · 73% consumer | not reported in cached trials |
| Diabetic nephropathy | 661 | 50.3 45.9–55.1ROR 50.4 · calibrated p 1e-5 ✓ | 35.3 EB05 33.1 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.3 (5.8–6.9) | Not in label — unassessed | serious n=660 · 79% consumer | not reported in cached trials |
| Adjustment disorder with depressed mood | 581 | 47.8 43.4–52.6ROR 47.9 · calibrated p 2e-5 ✓ | 34.1 EB05 31.8 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=581 · ♀ 100% (drug 58%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 493 | 45.0 40.6–49.9ROR 45.1 · calibrated p 3e-5 ✓ | 32.7 EB05 30.3 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=492 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 823 | 42.3 39.0–45.8ROR 42.5 · calibrated p 4e-5 ✓ | 31.2 EB05 29.5 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=823 · ♀ 100% (drug 58%) · 95% clinician | not reported in cached trials |
| Nephrosclerosis | 284 | 40.0 35.0–45.8ROR 40.1 · calibrated p 6e-5 ✓ | 30.0 EB05 27.1 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 13.3 (11.4–15.5) | Not in label — unassessed | serious n=284 · 100% consumer | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 168 | 39.6 33.3–47.2ROR 39.7 · calibrated p 6e-5 ✓ | 29.7 EB05 26.1 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=168 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 520 | 36.0 32.6–39.7ROR 36.1 · calibrated p 1e-4 ✓ | 27.7 EB05 25.7 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=519 · ♀ 100% (drug 58%) · 91% clinician | not reported in cached trials |
| Facet joint syndrome | 709 | 34.2 31.4–37.2ROR 34.3 · calibrated p 1e-4 ✓ | 26.6 EB05 25.0 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 179.4 (139.0–231.6) | Not in label — unassessed | serious n=708 · ♀ 100% (drug 58%) · 94% clinician | not reported in cached trials |
| Tubulointerstitial nephritis | 4,175 | 33.8 32.7–35.0ROR 34.6 · calibrated p 1e-4 ✓ | 26.4 EB05 25.7 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.4 (4.3–4.5) | Labeled adverse reaction exact term | age-adj. PRR 9.0 · serious PRR 17.4 | not reported in cached trials |
| Rheumatic fever | 927 | 31.7 29.5–34.1ROR 31.9 · calibrated p 2e-4 ✓ | 25.1 EB05 23.8 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=927 · ♀ 100% (drug 58%) · 94% clinician | not reported in cached trials |
| Atrial tachycardia | 435 | 30.6 27.5–34.0ROR 30.7 · calibrated p 2e-4 ✓ | 24.4 EB05 22.5 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.4 (3.1–3.8) | Not in label — unassessed | serious n=434 | not reported in cached trials |
| Duodenal ulcer perforation | 1,346 | 26.4 24.9–28.0ROR 26.6 · calibrated p 5e-4 ✓ | 21.7 EB05 20.7 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 330.3 (258.1–422.7) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.3 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| Pruritus genital | 423 | 26.1 23.5–29.0ROR 26.2 · calibrated p 5e-4 ✓ | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.6 (3.3–4.0) | Labeled (related wording) related wording | serious n=419 | not reported in cached trials |
| Rheumatoid factor positive | 1,015 | 25.1 23.5–26.9ROR 25.3 · calibrated p 6e-4 ✓ | 20.8 EB05 19.8 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 86.1 (73.8–100.4) | Lab value / disease marker | serious n=1,015 · ♀ 100% (drug 58%) · 96% clinician | not reported in cached trials |
| Porphyria acute | 240 | 24.8 21.5–28.5ROR 24.8 · calibrated p 7e-4 ✓ | 20.6 EB05 18.5 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=240 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 157 | 24.3 20.5–28.9ROR 24.3 · calibrated p 8e-4 ✓ | 20.2 EB05 17.7 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 16.1 (12.9–20.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=157 | not reported in cached trials |
| Peripheral venous disease | 682 | 24.2 22.3–26.3ROR 24.3 · calibrated p 8e-4 ✓ | 20.2 EB05 19.0 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Labeled (related wording) related wording | serious n=681 · ♀ 100% (drug 58%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,194 | 23.8 22.3–25.3ROR 23.9 · calibrated p 8e-4 ✓ | 19.9 EB05 19.0 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious PRR 13.2 · ♀ 100% (drug 58%) · 95% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Kidney injury | 33,813 | 9.49.3–9.5 | signal |
| Hyponatraemia | 3,050 | 4.64.5–4.8 | signal |
| Interstitial lung disease | 2,814 | 3.53.4–3.7 | signal |
| Gi bleeding | 3,813 | 2.52.4–2.6 | signal |
| Severe cutaneous reaction | 1,524 | 2.52.3–2.6 | signal |
| Anaphylaxis / angioedema | 2,364 | 2.32.2–2.4 | signal |
| Pancreatitis | 1,491 | 2.22.1–2.3 | signal |
| Liver injury | 5,573 | 2.22.2–2.3 | signal |
| Rhabdomyolysis / myopathy | 1,495 | 2.22.1–2.3 | signal |
| Arrhythmia / qt | 3,301 | 2.02.0–2.1 | raised |
| Neutropenia / agranulocytosis | 4,142 | 2.01.9–2.1 | raised |
| Anaemia | 4,899 | 1.91.9–2.0 | raised |
| Depression | 4,187 | 1.81.7–1.8 | raised |
| Hyperglycaemia / diabetes | 5,094 | 1.81.7–1.8 | raised |
| Thrombocytopenia | 3,186 | 1.71.7–1.8 | raised |
| Heart failure | 2,528 | 1.71.6–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lansoprazole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01990339 — Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms (N=14965, phase n/a; 10 AE terms posted; arms: Lansoprazole)
- NCT02099708 — Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non- (N=3502, phase n/a; 50 AE terms posted; arms: Lansoprazole 15 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 32,791 | 88.7 87.5–89.9ROR 108.6 · calibrated p 6e-8 ✓ | 50.7 EB05 50.2 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.8 (4.8–4.8) | Labeled (related wording) related wording | age-adj. PRR 27.8 · serious PRR 33.4 · 70% consumer | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 18,792 | 16.6 16.3–16.8ROR 18.4 · calibrated p 0.003 ✓ | 14.6 EB05 14.4 · IC025 +3.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.3 (4.2–4.3) | Labeled (related wording) related wording | age-adj. PRR 5.5 · serious PRR 9.6 | not reported in cached trials |
| Renal failure (kidney failure) | 13,842 | 13.6 13.3–13.8ROR 14.6 · calibrated p 0.008 ✓ | 12.3 EB05 12.1 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.3 (4.3–4.4) | Labeled (related wording) related wording | age-adj. PRR 5.1 · serious PRR 8.1 | NCT02099708: 1/3,302 (0.0%) on Lansoprazole (serious AE) |
| End stage renal disease | 9,798 | 135.5 131.6–139.4ROR 143.4 · calibrated p 7e-9 ✓ | 63.0 EB05 61.9 · IC025 +5.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.1 (5.0–5.2) | Not in label — unassessed | serious PRR 41.5 | not reported in cached trials |
| Renal injury | 9,519 | 54.9 53.6–56.2ROR 57.9 · calibrated p 5e-6 ✓ | 37.5 EB05 36.9 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.5) | Labeled (related wording) related wording | serious PRR 24.8 · 73% consumer | not reported in cached trials |
| Nausea | 9,256 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.586 | 1.4 EB05 1.4 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 2.1 (2.1–2.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 9,102 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.783 | 1.7 EB05 1.6 · IC025 +0.7 vs other Proton Pump Inhibitors: PRR 2.2 (2.2–2.3) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.7 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 8,288 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.820 | 1.7 EB05 1.7 · IC025 +0.8 vs other Proton Pump Inhibitors: PRR 2.4 (2.4–2.5) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.5 | NCT02099708: 1/3,302 (0.0%) on Lansoprazole (serious AE) |
| Fatigue (tiredness) | 7,966 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.458 | 1.2 EB05 1.2 · IC025 +0.2 vs other Proton Pump Inhibitors: PRR 2.0 (1.9–2.0) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.3 | not reported in cached trials |
| Vomiting | 7,319 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.888 | 1.8 EB05 1.8 · IC025 +0.8 vs other Proton Pump Inhibitors: PRR 2.6 (2.5–2.6) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 1.6 | not reported in cached trials |
| Off label use (used outside approved label) | 7,253 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.299 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 2.4 (2.4–2.5) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.0 | not reported in cached trials |
| Headache | 7,019 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.538 | 1.3 EB05 1.3 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 2.1 (2.1–2.2) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.5 | not reported in cached trials |
| Pain | 6,919 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.541 | 1.3 EB05 1.3 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 2.1 (2.1–2.2) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.2 | not reported in cached trials |
| Drug ineffective (drug did not work) | 6,659 | 0.6 0.6–0.6ROR 0.6 · calibrated p 0.077 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 1.7 (1.7–1.7) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.8 | not reported in cached trials |
| Dizziness | 6,206 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.642 | 1.5 EB05 1.4 · IC025 +0.5 vs other Proton Pump Inhibitors: PRR 2.3 (2.3–2.4) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.5 | NCT01990339: 1/13,514 (0.0%) on Lansoprazole (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Renal haemangioma — n=790, PRR 13,077.1
- Appendicolith — n=294, PRR 420.6
- Hypertensive nephropathy — n=671, PRR 197.3
- Immunisation — n=261, PRR 181.1
- Grip strength — n=128, PRR 146.8
- Palmoplantar keratoderma — n=393, PRR 143.2
- End stage renal disease — n=9,798, PRR 135.5
- Chronic kidney disease-mineral and bone disorder — n=542, PRR 120.8
- Nephrogenic anaemia — n=2,215, PRR 107.0
- Deep vein thrombosis postoperative — n=754, PRR 73.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Lansoprazole?
In FDA FAERS, the most frequently co-reported reaction terms for Lansoprazole are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Lansoprazole have an FDA boxed warning?
No. The FDA label retrieved for Lansoprazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lansoprazole causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd, effective 20231128; matched on
openfda.generic_name.exact:"LANSOPRAZOLE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3883 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,201 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
LANSOPRAZOLE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.