Drug · FAERS side-effect profile with label screen

Levorphanol side effects: what 367 FDA adverse event reports show

Levorphanol Tartrate · 7 reaction terms · 69 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Levorphanol Tartrate (Levorphanol Tartrate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

367 reports · 23% serious · 20 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and d.

FDA label, Indications and Usage

What it is

DESCRIPTION Levorphanol tartrate tablets USP, contain levorphanol, an opioid agonist with a molecular formula of C 17 H 23 NO • C 4 H 6 O 6 • 2H 2 O and molecular weight 443.5. Each milligram of levorphanol tartrate is equivalent to 0.58 mg levorphanol base.

FDA label, Description section

Boxed warning

SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS Addiction, Abuse, and Misuse Because the use of levorph.

FDA 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 6 strongest signals

Labeled — boxed warning 1Labeled (related wording) 2Reporting / coding artifact 3

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product availability issue	12	30.6 17.5–53.4ROR 31.6 · χ² 315 / p 1e-70	29.3 EB05 17.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug withdrawal syndrome neonatal	6	22.9 10.4–50.7ROR 23.3 · χ² 105 / p 6e-25	20.0 EB05 7.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 56.4	no trial data cached
Drug toxicity	5	20.7 8.7–49.4ROR 21.0 · χ² 75 / p 2e-18	16.4 EB05 5.2 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 52.9	no trial data cached
Product dose omission	21	18.1 12.0–27.5ROR 19.2 · χ² 324 / p 1e-72	17.7 EB05 12.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Withdrawal syndrome	12	16.2 9.3–28.3ROR 16.8 · χ² 157 / p 3e-36	15.1 EB05 8.3 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 4.8	no trial data cached
Drug dependence	9	3.2 1.7–6.0ROR 3.2 · χ² 11 / p 4e-4	2.8 EB05 1.6 · IC025 +0.4	Reporting / coding artifact	serious PRR 7.9	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
Product dose omission	21	18.1 12.0–27.5ROR 19.2 · χ² 324 / p 1e-72	17.7 EB05 12.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Withdrawal syndrome	12	16.2 9.3–28.3ROR 16.8 · χ² 157 / p 3e-36	15.1 EB05 8.3 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 4.8	no trial data cached
Product availability issue	12	30.6 17.5–53.4ROR 31.6 · χ² 315 / p 1e-70	29.3 EB05 17.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug dependence	9	3.2 1.7–6.0ROR 3.2 · χ² 11 / p 4e-4	2.8 EB05 1.6 · IC025 +0.4	Reporting / coding artifact	serious PRR 7.9	no trial data cached
Drug withdrawal syndrome neonatal	6	22.9 10.4–50.7ROR 23.3 · χ² 105 / p 6e-25	20.0 EB05 7.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 56.4	no trial data cached
Drug toxicity	5	20.7 8.7–49.4ROR 21.0 · χ² 75 / p 2e-18	16.4 EB05 5.2 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 52.9	no trial data cached
Inability to afford medication	4	23.3 8.8–61.6ROR 23.5 · χ² 64 / p 5e-16	17.2 EB05 4.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Levorphanol?

In FDA FAERS, the most frequently co-reported reaction terms for Levorphanol are withdrawal syndrome, drug withdrawal syndrome neonatal, drug toxicity, inability to afford medication. 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 Levorphanol have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS Addiction, Abuse, and Misuse Because the use of levorph.

Do FAERS signals prove that Levorphanol 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 438cf3ea-04fe-4626-9f0f-adcda7633651, effective 20260113; matched on openfda.generic_name.exact:"LEVORPHANOL TARTRATE")
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, field patient.drug.openfda.generic_name.exact, 7 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.