Drug · FAERS side-effect profile with label screen
Lubiprostone side effects: what 9,401 FDA adverse event reports show
Drug class
Chloride Channel Activator
FDA label (Established Pharmacologic Class)
Who reports
9,401 reports · 67% serious · 961 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
FDA label, Indications and Usage
What it is
Lubiprostone is a chloride channel activator for oral use.
FDA label, Description section
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 (related wording) 2Likely indication confounding 1Not in label — unassessed 37
What the badges mean
- 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,054 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 |
|---|---|---|---|---|---|---|
| Toxic optic neuropathy | 13 | 69.4 40.0–120.5ROR 69.5 · χ² 785 / p 6e-173 | 61.5 EB05 38.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Nephrogenic anaemia | 66 | 31.9 25.1–40.7ROR 32.1 · χ² 1,919 / p <1e-300 | 31.2 EB05 25.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=66 | no trial data cached |
| Hyperparathyroidism secondary | 33 | 29.4 20.9–41.5ROR 29.5 · χ² 867 / p 8e-191 | 28.6 EB05 21.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=33 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 14 | 29.4 17.3–49.8ROR 29.4 · χ² 351 / p 1e-78 | 28.0 EB05 17.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Rebound acid hypersecretion | 36 | 26.5 19.1–36.8ROR 26.6 · χ² 847 / p 2e-186 | 25.9 EB05 19.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=36 | no trial data cached |
| Marasmus | 16 | 24.0 14.6–39.2ROR 24.0 · χ² 326 / p 4e-73 | 23.1 EB05 15.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Metabolic alkalosis | 14 | 19.7 11.7–33.4ROR 19.8 · χ² 229 / p 6e-52 | 18.9 EB05 11.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Volvulus | 15 | 14.4 8.7–24.0ROR 14.4 · χ² 173 / p 8e-40 | 13.4 EB05 7.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Faeces hard | 22 | 12.7 8.4–19.3ROR 12.7 · χ² 224 / p 5e-51 | 11.9 EB05 7.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=18 · 71% consumer | no trial data cached |
| Dyschezia | 17 | 12.6 7.8–20.3ROR 12.6 · χ² 170 / p 4e-39 | 11.6 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pyelonephritis acute | 11 | 12.6 7.0–22.8ROR 12.6 · χ² 106 / p 4e-25 | 10.8 EB05 5.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pre-existing condition improved | 35 | 12.4 8.9–17.3ROR 12.5 · χ² 355 / p 2e-79 | 12.0 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 70%) | no trial data cached |
| End stage renal disease | 102 | 12.4 10.2–15.1ROR 12.5 · χ² 1,054 / p 2e-231 | 12.2 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Ileus | 61 | 11.1 8.6–14.3ROR 11.2 · χ² 548 / p 1e-121 | 10.8 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 50% (drug 70%) | no trial data cached |
| Impaired gastric emptying | 63 | 11.1 8.6–14.2ROR 11.1 · χ² 564 / p 5e-125 | 10.8 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Gastrointestinal hypomotility | 11 | 11.0 6.1–20.0ROR 11.1 · χ² 90 / p 1e-21 | 9.1 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 26 | 10.6 7.2–15.6ROR 10.6 · χ² 216 / p 3e-49 | 9.8 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Stoma site discharge | 12 | 9.8 5.6–17.3ROR 9.8 · χ² 86 / p 1e-20 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Chronic kidney disease | 334 | 9.8 8.8–10.8ROR 10.1 · χ² 2,614 / p <1e-300 | 9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Faecaloma | 22 | 9.1 6.0–13.8ROR 9.1 · χ² 149 / p 1e-34 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Hypercapnia | 12 | 9.0 5.1–15.8ROR 9.0 · χ² 77 / p 9e-19 | 7.3 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cardiac failure chronic | 17 | 8.9 5.6–14.4ROR 9.0 · χ² 112 / p 2e-26 | 7.7 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Enterocolitis | 21 | 8.2 5.4–12.6ROR 8.2 · χ² 126 / p 2e-29 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 48% (drug 70%) · 100% clinician | no trial data cached |
| Colitis ischaemic | 24 | 8.0 5.4–11.9ROR 8.0 · χ² 139 / p 2e-32 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · 100% clinician | no trial data cached |
| Hangover | 12 | 7.6 4.3–13.4ROR 7.6 · χ² 62 / p 2e-15 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Thyroiditis | 10 | 7.5 4.0–14.0ROR 7.5 · χ² 50 / p 8e-13 | 5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Irritable bowel syndrome | 71 | 7.4 5.9–9.4ROR 7.5 · χ² 388 / p 1e-86 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 | no trial data cached |
| Bowel movement irregularity | 25 | 7.3 5.0–10.9ROR 7.4 · χ² 130 / p 2e-30 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Cholangitis | 20 | 7.3 4.7–11.2ROR 7.3 · χ² 101 / p 4e-24 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Cystic fibrosis | 18 | 7.2 4.6–11.5ROR 7.2 · χ² 90 / p 1e-21 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Family stress | 10 | 7.1 3.8–13.2ROR 7.1 · χ² 47 / p 5e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hyperuricaemia | 13 | 7.1 4.1–12.2ROR 7.1 · χ² 62 / p 2e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Ileus paralytic | 14 | 7.0 4.2–11.9ROR 7.1 · χ² 67 / p 2e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Abdominal adhesions | 10 | 7.0 3.8–13.1ROR 7.1 · χ² 46 / p 6e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Cholecystitis chronic | 21 | 6.9 4.5–10.6ROR 6.9 · χ² 100 / p 7e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 100% (drug 70%) | no trial data cached |
| Somnambulism | 20 | 6.8 4.4–10.5ROR 6.8 · χ² 93 / p 3e-22 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Anal incontinence | 27 | 6.8 4.7–9.9ROR 6.8 · χ² 127 / p 9e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Gastrointestinal motility disorder | 16 | 6.7 4.1–11.0ROR 6.8 · χ² 72 / p 9e-18 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cerebral atrophy | 12 | 6.7 3.8–11.8ROR 6.7 · χ² 53 / p 2e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Spinal compression fracture | 25 | 6.7 4.5–9.8ROR 6.7 · χ² 114 / p 6e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 50% (drug 70%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Nausea | 792 | 2.2 2.1–2.4ROR 2.4 · χ² 563 / p 9e-125 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 634 | 2.5 2.3–2.7ROR 2.6 · χ² 585 / p 2e-129 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Diarrhoea (diarrhea) | 619 | 2.1 2.0–2.3ROR 2.2 · χ² 390 / p 4e-87 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Constipation | 581 | 6.0 5.5–6.5ROR 6.3 · χ² 2,435 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.8 | no trial data cached |
| Drug ineffective (drug did not work) | 560 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.102 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Fatigue (tiredness) | 535 | 1.5 1.4–1.7ROR 1.6 · χ² 103 / p 1e-24 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Pain | 495 | 1.8 1.6–2.0ROR 1.8 · χ² 179 / p 5e-41 | 1.8 EB05 1.7 · IC025 +0.7 | Likely indication confounding term in indications; also in warnings | serious PRR 1.7 | no trial data cached |
| Headache | 492 | 1.8 1.6–1.9ROR 1.8 · χ² 163 / p 1e-37 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Dizziness | 452 | 2.0 1.9–2.2ROR 2.1 · χ² 239 / p 3e-54 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Fall | 407 | 2.7 2.5–3.0ROR 2.8 · χ² 452 / p 1e-100 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Vomiting | 400 | 1.9 1.7–2.1ROR 1.9 · χ² 174 / p 4e-40 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Off label use (used outside approved label) | 343 | 0.9 0.8–1.0ROR 0.9 · χ² 6 / p 0.009 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Chronic kidney disease | 334 | 9.8 8.8–10.8ROR 10.1 · χ² 2,614 / p <1e-300 | 9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Malaise (feeling unwell) | 320 | 1.6 1.5–1.8ROR 1.6 · χ² 78 / p 6e-19 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Pyrexia (fever) | 301 | 1.9 1.7–2.2ROR 2.0 · χ² 138 / p 3e-32 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
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.
- Nephrogenic anaemia — n=66, PRR 31.9
- Hyperparathyroidism secondary — n=33, PRR 29.4
- Rebound acid hypersecretion — n=36, PRR 26.5
- Pre-existing condition improved — n=35, PRR 12.4
- End stage renal disease — n=102, PRR 12.4
- Ileus — n=61, PRR 11.1
- Impaired gastric emptying — n=63, PRR 11.1
- Infective pulmonary exacerbation of cystic fibrosis — n=26, PRR 10.6
- Chronic kidney disease — n=334, PRR 9.8
- Faecaloma — n=22, PRR 9.1
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 Lubiprostone?
In FDA FAERS, the most frequently co-reported reaction terms for Lubiprostone are nausea, dyspnoea, diarrhoea, constipation, fatigue, pain. 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 Lubiprostone have an FDA boxed warning?
No. The FDA label retrieved for Lubiprostone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lubiprostone 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 10c7b62d-6c39-453c-8d9a-2f441725bc3b, effective 20251222; matched on
openfda.generic_name.exact:"LUBIPROSTONE") - 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, 1,094 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
Page generated 2026-10-08. 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.