Drug · FAERS side-effect profile with label screen
Naltrexone and Bupropion side effects: what 8,477 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Naltrexone (Naltrexone)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
8,477 reports · 33% serious · 29 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. Naltrexone for extended-release injectable suspension contains naltrexone, an opioid antagonis.
FDA label, Indications and Usage
What it is
Naltrexone for extended-release injectable suspension is supplied as a microsphere formulation of naltrexone for suspension, to be administered by deep intramuscular injection by a healthcare practitioner.
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 1Reporting / coding artifact 7Not in label — unassessed 30
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.
- 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. 858 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 |
|---|---|---|---|---|---|---|
| Lack of concomitant drug effect | 11 | 624.2 322.0–1,210.0ROR 625.0 · χ² 4,965 / p <1e-300 | 266.9 EB05 159.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Patient dissatisfaction with treatment | 344 | 550.0 490.3–617.1ROR 573.3 · χ² 153,414 / p <1e-300 | 438.1 EB05 400.6 · IC025 +7.9 3/3 methods agree | Labeled (related wording) related wording | serious n=108 · 90% consumer | no trial data cached |
| Cervicogenic headache | 18 | 385.3 234.5–633.1ROR 386.1 · χ² 5,631 / p <1e-300 | 246.1 EB05 164.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Drug titration error | 333 | 365.8 326.7–409.7ROR 380.8 · χ² 105,059 / p <1e-300 | 312.6 EB05 285.4 · IC025 +7.6 3/3 methods agree | Reporting / coding artifact | serious n=251 · 82% consumer | no trial data cached |
| Pineal gland cyst | 18 | 363.0 221.3–595.3ROR 363.8 · χ² 5,345 / p <1e-300 | 236.8 EB05 158.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Labelled drug-food interaction issue | 14 | 237.2 137.1–410.5ROR 237.6 · χ² 2,790 / p <1e-300 | 167.4 EB05 106.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Labelled drug-drug interaction issue | 88 | 165.4 133.4–205.1ROR 167.2 · χ² 13,316 / p <1e-300 | 150.0 EB05 125.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=73 · 76% consumer | no trial data cached |
| Migraine without aura | 18 | 158.6 98.5–255.3ROR 158.9 · χ² 2,500 / p <1e-300 | 128.9 EB05 86.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Food craving | 206 | 107.3 93.5–123.2ROR 109.9 · χ² 20,681 / p <1e-300 | 101.9 EB05 90.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=158 · 82% consumer | no trial data cached |
| Contraindicated drug administered | 27 | 97.9 66.7–143.7ROR 98.2 · χ² 2,397 / p <1e-300 | 88.4 EB05 63.8 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Contraindicated product prescribed | 50 | 76.3 57.6–101.0ROR 76.7 · χ² 3,531 / p <1e-300 | 72.1 EB05 56.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=45 · 84% consumer | no trial data cached |
| Food aversion | 47 | 71.7 53.7–95.7ROR 72.1 · χ² 3,114 / p <1e-300 | 67.8 EB05 53.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=38 · 81% consumer | no trial data cached |
| Alcohol intolerance | 16 | 57.2 34.9–93.9ROR 57.4 · χ² 810 / p 2e-178 | 52.7 EB05 34.4 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Labelled drug-food interaction medication error | 11 | 55.2 30.4–100.4ROR 55.3 · χ² 521 / p 1e-115 | 49.7 EB05 29.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Cyclic vomiting syndrome | 10 | 40.2 21.5–75.1ROR 40.2 · χ² 338 / p 7e-76 | 37.0 EB05 21.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nonspecific reaction | 78 | 36.3 29.1–45.4ROR 36.6 · χ² 2,605 / p <1e-300 | 35.5 EB05 29.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=8 · 92% consumer | no trial data cached |
| Binge eating | 13 | 30.3 17.5–52.3ROR 30.3 · χ² 335 / p 3e-75 | 28.8 EB05 17.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hunger | 157 | 29.2 25.0–34.1ROR 29.7 · χ² 4,202 / p <1e-300 | 28.8 EB05 25.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=108 · 77% consumer | no trial data cached |
| Drug dose titration not performed | 20 | 29.0 18.7–45.1ROR 29.1 · χ² 508 / p 9e-113 | 28.0 EB05 19.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=19 · 75% consumer | no trial data cached |
| Inability to afford medication | 92 | 23.4 19.0–28.6ROR 23.6 · χ² 1,929 / p <1e-300 | 23.0 EB05 19.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=71 · 96% consumer | no trial data cached |
| Intentional underdose | 57 | 19.5 15.0–25.3ROR 19.6 · χ² 974 / p 4e-214 | 19.2 EB05 15.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=43 · 77% consumer | no trial data cached |
| Energy increased | 46 | 19.3 14.5–25.8ROR 19.4 · χ² 774 / p 1e-170 | 19.0 EB05 14.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 · 83% consumer | no trial data cached |
| Biliary colic | 22 | 19.1 12.5–29.0ROR 19.1 · χ² 356 / p 9e-80 | 18.6 EB05 12.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=20 · 82% consumer | no trial data cached |
| Contraindicated product administered | 222 | 18.3 16.1–20.9ROR 18.8 · χ² 3,599 / p <1e-300 | 18.2 EB05 16.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 33.2 · 75% consumer | no trial data cached |
| Obstructive sleep apnoea syndrome | 10 | 17.8 9.6–33.2ROR 17.9 · χ² 142 / p 6e-33 | 16.3 EB05 8.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tension headache | 30 | 17.4 12.1–24.9ROR 17.4 · χ² 444 / p 8e-99 | 17.0 EB05 12.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | no trial data cached |
| Product prescribing error | 163 | 17.1 14.7–20.0ROR 17.5 · χ² 2,447 / p <1e-300 | 17.0 EB05 14.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 29.8 | no trial data cached |
| Feeling jittery | 127 | 16.6 13.9–19.7ROR 16.8 · χ² 1,830 / p <1e-300 | 16.4 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=34 · 73% consumer | no trial data cached |
| Motion sickness | 11 | 14.3 7.9–25.8ROR 14.3 · χ² 122 / p 1e-28 | 12.6 EB05 6.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Hangover | 20 | 14.1 9.1–21.8ROR 14.1 · χ² 228 / p 7e-52 | 13.3 EB05 8.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 · 70% consumer | no trial data cached |
| Tunnel vision | 10 | 13.4 7.2–24.9ROR 13.4 · χ² 102 / p 3e-24 | 11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Gastric bypass | 11 | 12.6 6.9–22.7ROR 12.6 · χ² 105 / p 6e-25 | 10.7 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Labelled drug-drug interaction medication error | 44 | 12.3 9.1–16.5ROR 12.3 · χ² 441 / p 3e-98 | 11.9 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
| Foreign body in throat | 14 | 11.4 6.8–19.3ROR 11.5 · χ² 123 / p 8e-29 | 10.0 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Brain fog | 66 | 11.2 8.8–14.3ROR 11.3 · χ² 603 / p 2e-133 | 11.0 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 82% consumer | no trial data cached |
| Taste disorder | 78 | 9.7 7.7–12.1ROR 9.7 · χ² 595 / p 9e-132 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · 74% consumer | no trial data cached |
| Postmenopausal haemorrhage | 10 | 9.6 5.2–17.9ROR 9.6 · χ² 69 / p 6e-17 | 7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Faeces hard | 15 | 9.6 5.8–15.9ROR 9.6 · χ² 107 / p 3e-25 | 8.2 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hyperphagia | 15 | 9.4 5.7–15.6ROR 9.4 · χ² 104 / p 1e-24 | 8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Symptom recurrence | 22 | 9.3 6.1–14.1ROR 9.3 · χ² 154 / p 1e-35 | 8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=22 · 91% consumer | 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 | 1,984 | 6.2 6.0–6.5ROR 7.8 · χ² 9,031 / p <1e-300 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 76% consumer | no trial data cached |
| Headache | 1,112 | 4.4 4.2–4.6ROR 4.9 · χ² 3,002 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 78% consumer | no trial data cached |
| Dizziness | 1,046 | 5.2 4.9–5.5ROR 5.8 · χ² 3,629 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · 77% consumer | no trial data cached |
| Vomiting | 675 | 3.6 3.3–3.8ROR 3.8 · χ² 1,270 / p 2e-278 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 73% consumer | no trial data cached |
| Constipation | 647 | 7.4 6.9–8.0ROR 7.9 · χ² 3,611 / p <1e-300 | 7.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.3 · 79% consumer | no trial data cached |
| Feeling abnormal | 583 | 6.0 5.6–6.5ROR 6.4 · χ² 2,451 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 74% consumer | no trial data cached |
| Fatigue (tiredness) | 524 | 1.7 1.5–1.8ROR 1.7 · χ² 145 / p 1e-33 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 3.4 · 74% consumer | no trial data cached |
| Anxiety | 405 | 3.5 3.2–3.9ROR 3.6 · χ² 735 / p 3e-162 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 74% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 395 | 3.7 3.3–4.0ROR 3.8 · χ² 772 / p 3e-170 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 79% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 374 | 1.4 1.3–1.6ROR 1.5 · χ² 51 / p 4e-13 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.1 · 72% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 367 | 0.7 0.6–0.8ROR 0.7 · χ² 54 / p 8e-14 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 · 72% consumer | no trial data cached |
| Patient dissatisfaction with treatment | 344 | 550.0 490.3–617.1ROR 573.3 · χ² 153,414 / p <1e-300 | 438.1 EB05 400.6 · IC025 +7.9 3/3 methods agree | Labeled (related wording) related wording | serious n=108 · 90% consumer | no trial data cached |
| Tremor (shaking) | 335 | 5.0 4.5–5.5ROR 5.2 · χ² 1,072 / p 2e-235 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 80% consumer | no trial data cached |
| Drug titration error | 333 | 365.8 326.7–409.7ROR 380.8 · χ² 105,059 / p <1e-300 | 312.6 EB05 285.4 · IC025 +7.6 3/3 methods agree | Reporting / coding artifact | serious n=251 · 82% consumer | no trial data cached |
| Illness | 332 | 8.2 7.4–9.1ROR 8.5 · χ² 2,094 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 88% 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.
- Food craving — n=206, PRR 107.3
- Food aversion — n=47, PRR 71.7
- Nonspecific reaction — n=78, PRR 36.3
- Hunger — n=157, PRR 29.2
- Drug dose titration not performed — n=20, PRR 29.0
- Inability to afford medication — n=92, PRR 23.4
- Intentional underdose — n=57, PRR 19.5
- Energy increased — n=46, PRR 19.3
- Biliary colic — n=22, PRR 19.1
- Feeling jittery — n=127, PRR 16.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Naltrexone ↔ Drug withdrawal syndrome.
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 Naltrexone and Bupropion?
In FDA FAERS, the most frequently co-reported reaction terms for Naltrexone and Bupropion are nausea, headache, dizziness, vomiting, constipation, feeling abnormal. 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 Naltrexone and Bupropion have an FDA boxed warning?
No. The FDA label retrieved for Naltrexone and Bupropion has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naltrexone and Bupropion 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 6de5637f-d527-4228-af1a-3aae71155cb5, effective 20260130; matched on
openfda.generic_name.exact:"NALTREXONE") - 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, 898 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.