Drug · FAERS side-effect profile with label screen
Naloxegol Oxalate side effects: what 3,899 FDA adverse event reports show
Drug class
Opioid antagonist
FDA label, Indications wording
Brand names
Movantik
openFDA label
Who reports
3,899 reports · 47% serious · 286 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
MOVANTIK ® is indicated for the treatment of 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
MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.)
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 adverse reaction 7Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 27
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.
- 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. 145 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 |
|---|---|---|---|---|---|---|
| Intentional product misuse | 223 | 13.8 12.2–15.7ROR 14.6 · χ² 2,645 / p <1e-300 | 13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 73% consumer | no trial data cached |
| Gastrointestinal pain | 28 | 13.8 9.5–19.9ROR 13.9 · χ² 318 / p 2e-71 | 13.3 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 75% consumer | no trial data cached |
| Body height decreased | 27 | 13.5 9.2–19.6ROR 13.5 · χ² 298 / p 4e-67 | 13.0 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 · 76% consumer | no trial data cached |
| Withdrawal syndrome | 101 | 12.9 10.6–15.6ROR 13.2 · χ² 1,095 / p 2e-240 | 12.8 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Drug withdrawal syndrome | 154 | 9.3 8.0–10.9ROR 9.7 · χ² 1,142 / p 1e-250 | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Constipation | 375 | 9.3 8.5–10.3ROR 10.2 · χ² 2,804 / p <1e-300 | 9.3 EB05 8.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.2 · 71% consumer | no trial data cached |
| Frequent bowel movements | 45 | 9.0 6.7–12.0ROR 9.1 · χ² 312 / p 4e-70 | 8.5 EB05 6.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.1 · 85% consumer | no trial data cached |
| Flatulence (gas) | 94 | 8.9 7.3–10.9ROR 9.1 · χ² 655 / p 7e-145 | 8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 89% consumer | no trial data cached |
| Hospice care | 16 | 8.7 5.4–14.3ROR 8.8 · χ² 102 / p 3e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Bladder disorder | 15 | 8.1 4.9–13.4ROR 8.1 · χ² 86 / p 7e-21 | 6.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 27 | 7.9 5.4–11.4ROR 7.9 · χ² 155 / p 8e-36 | 7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 4% (drug 59%) · 100% clinician | no trial data cached |
| Weight fluctuation | 15 | 7.7 4.7–12.8ROR 7.8 · χ² 81 / p 9e-20 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 185 | 7.7 6.7–8.9ROR 8.1 · χ² 1,080 / p 3e-237 | 7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Nerve injury | 14 | 6.8 4.0–11.4ROR 6.8 · χ² 63 / p 1e-15 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Inability to afford medication | 12 | 6.6 3.7–11.6ROR 6.6 · χ² 51 / p 4e-13 | 5.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Insurance issue | 18 | 6.5 4.1–10.3ROR 6.5 · χ² 79 / p 4e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Back injury | 13 | 6.5 3.8–11.1ROR 6.5 · χ² 55 / p 7e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Intervertebral disc degeneration | 11 | 6.4 3.5–11.5ROR 6.4 · χ² 44 / p 1e-11 | 5.2 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Impaired gastric emptying | 15 | 6.3 3.8–10.5ROR 6.3 · χ² 62 / p 2e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Spinal disorder | 11 | 6.2 3.5–11.3ROR 6.2 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Spinal operation | 14 | 6.2 3.7–10.5ROR 6.2 · χ² 56 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Retching | 24 | 6.1 4.1–9.0ROR 6.1 · χ² 97 / p 4e-23 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Abdominal pain upper | 228 | 6.0 5.3–6.8ROR 6.3 · χ² 947 / p 4e-208 | 5.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 87% consumer | no trial data cached |
| Abdominal pain | 258 | 6.0 5.3–6.7ROR 6.3 · χ² 1,073 / p 1e-235 | 5.9 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Hepatic cytolysis | 13 | 5.7 3.3–9.8ROR 5.7 · χ² 46 / p 6e-12 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 10 | 5.3 2.8–9.8ROR 5.3 · χ² 31 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Chills | 112 | 5.1 4.3–6.2ROR 5.3 · χ² 370 / p 9e-83 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Chronic kidney disease | 71 | 5.0 4.0–6.3ROR 5.1 · χ² 223 / p 1e-50 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| End stage renal disease | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 8e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Back disorder | 15 | 4.9 3.0–8.2ROR 5.0 · χ² 43 / p 2e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Muscle spasms | 168 | 4.9 4.2–5.7ROR 5.1 · χ² 525 / p 2e-116 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Feeding disorder | 18 | 4.9 3.1–7.7ROR 4.9 · χ² 51 / p 4e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Malnutrition | 10 | 4.8 2.6–9.0ROR 4.8 · χ² 27 / p 1e-7 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hernia | 17 | 4.7 3.0–7.6ROR 4.8 · χ² 47 / p 4e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Intestinal obstruction | 33 | 4.7 3.4–6.7ROR 4.8 · χ² 94 / p 2e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 81% (drug 59%) | no trial data cached |
| Restless legs syndrome | 16 | 4.7 2.9–7.7ROR 4.7 · χ² 43 / p 2e-11 | 4.2 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Hypophagia | 22 | 4.7 3.1–7.1ROR 4.7 · χ² 60 / p 5e-15 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Ischaemic stroke | 15 | 4.5 2.7–7.5ROR 4.5 · χ² 38 / p 4e-10 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Sleep apnoea syndrome | 16 | 4.5 2.8–7.3ROR 4.5 · χ² 40 / p 1e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Muscle spasticity | 10 | 4.3 2.3–8.1ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 380 | 3.2 2.9–3.5ROR 3.4 · χ² 582 / p 7e-129 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Constipation | 375 | 9.3 8.5–10.3ROR 10.2 · χ² 2,804 / p <1e-300 | 9.3 EB05 8.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.2 · 71% consumer | no trial data cached |
| Pain | 362 | 3.2 2.9–3.5ROR 3.4 · χ² 549 / p 1e-121 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.7 | no trial data cached |
| Abdominal pain | 258 | 6.0 5.3–6.7ROR 6.3 · χ² 1,073 / p 1e-235 | 5.9 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Abdominal pain upper | 228 | 6.0 5.3–6.8ROR 6.3 · χ² 947 / p 4e-208 | 5.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 87% consumer | no trial data cached |
| Intentional product misuse | 223 | 13.8 12.2–15.7ROR 14.6 · χ² 2,645 / p <1e-300 | 13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 73% consumer | no trial data cached |
| Hyperhidrosis (excessive sweating) | 185 | 7.7 6.7–8.9ROR 8.1 · χ² 1,080 / p 3e-237 | 7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Muscle spasms | 168 | 4.9 4.2–5.7ROR 5.1 · χ² 525 / p 2e-116 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Drug withdrawal syndrome | 154 | 9.3 8.0–10.9ROR 9.7 · χ² 1,142 / p 1e-250 | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Feeling abnormal | 114 | 2.5 2.1–3.1ROR 2.6 · χ² 107 / p 2e-25 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · 73% consumer | no trial data cached |
| Chills | 112 | 5.1 4.3–6.2ROR 5.3 · χ² 370 / p 9e-83 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Withdrawal syndrome | 101 | 12.9 10.6–15.6ROR 13.2 · χ² 1,095 / p 2e-240 | 12.8 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Abdominal discomfort | 94 | 3.0 2.5–3.7ROR 3.1 · χ² 126 / p 1e-29 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 85% consumer | no trial data cached |
| Flatulence (gas) | 94 | 8.9 7.3–10.9ROR 9.1 · χ² 655 / p 7e-145 | 8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 89% consumer | no trial data cached |
| Product use issue | 92 | 2.6 2.2–3.2ROR 2.7 · χ² 93 / p 2e-22 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 76% consumer | 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.
- Body height decreased — n=27, PRR 13.5
- Agranulocytosis — n=27, PRR 7.9
- Retching — n=24, PRR 6.1
- Chronic kidney disease — n=71, PRR 5.0
- Muscle spasms — n=168, PRR 4.9
- Hypophagia — n=22, PRR 4.7
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 Naloxegol Oxalate?
In FDA FAERS, the most frequently co-reported reaction terms for Naloxegol Oxalate are diarrhoea, constipation, pain, abdominal pain, abdominal pain upper, hyperhidrosis. 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 Naloxegol Oxalate have an FDA boxed warning?
No. The FDA label retrieved for Naloxegol Oxalate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naloxegol Oxalate 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 28596788-b73f-4247-85fc-3105f51fff5a, effective 20260901; matched on
openfda.generic_name.exact:"NALOXEGOL OXALATE") - 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, 185 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.