Drug · FAERS side-effect profile with label screen
Meperidine side effects: what 9,161 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Meperidine Hydrochloride (Meperidine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
9,161 reports · 64% serious · 746 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use • Because of the risks of addiction, .
FDA label, Indications and Usage
What it is
Meperidine hydrochloride is an opioid agonist, available as 50 mg and 100 mg tablets or 50 mg per 5 mL solution for oral administration.
FDA label, Description section
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution.
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 40 strongest signals
Labeled — boxed warning 1Labeled (related wording) 3Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 32
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,050 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 |
|---|---|---|---|---|---|---|
| Temperature regulation disorder | 271 | 324.5 286.1–367.9ROR 334.3 · χ² 76,133 / p <1e-300 | 278.2 EB05 251.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=271 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Contrast media allergy | 178 | 252.6 216.7–294.6ROR 257.6 · χ² 39,901 / p <1e-300 | 221.9 EB05 195.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=177 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Bloody discharge | 106 | 232.4 190.5–283.5ROR 235.1 · χ² 21,934 / p <1e-300 | 203.1 EB05 172.7 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 73%) | no trial arm names this drug |
| International normalised ratio fluctuation | 157 | 185.4 157.8–217.9ROR 188.6 · χ² 26,444 / p <1e-300 | 167.9 EB05 147.0 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=156 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Obliterative bronchiolitis | 83 | 152.9 122.5–190.7ROR 154.3 · χ² 11,587 / p <1e-300 | 138.7 EB05 115.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Neonatal hypoacusis | 14 | 145.0 84.5–248.8ROR 145.2 · χ² 1,748 / p <1e-300 | 115.3 EB05 73.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Myoglobin urine present | 14 | 135.7 79.1–232.6ROR 135.9 · χ² 1,641 / p <1e-300 | 109.4 EB05 69.2 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial arm names this drug |
| Administration related reaction | 10 | 130.5 69.0–246.8ROR 130.7 · χ² 1,096 / p 1e-240 | 100.4 EB05 58.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial arm names this drug |
| Food allergy | 383 | 122.3 110.6–135.2ROR 127.6 · χ² 43,601 / p <1e-300 | 115.4 EB05 106.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=381 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Foetal death | 258 | 119.9 106.0–135.7ROR 123.3 · χ² 28,780 / p <1e-300 | 113.0 EB05 101.9 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=258 · ♀ 100% (drug 73%) · 92% clinician | no trial arm names this drug |
| Vision abnormal neonatal | 20 | 113.5 72.4–177.7ROR 113.7 · χ² 2,017 / p <1e-300 | 98.2 EB05 67.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 45% (drug 73%) · 100% consumer | no trial arm names this drug |
| Product used for unknown indication | 49 | 93.6 70.4–124.5ROR 94.1 · χ² 4,222 / p <1e-300 | 87.0 EB05 68.4 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=49 · ♀ 0% (drug 73%) | no trial arm names this drug |
| Facial wasting | 10 | 89.3 47.5–167.8ROR 89.3 · χ² 757 / p 7e-167 | 74.2 EB05 43.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Lyme disease | 102 | 72.6 59.6–88.3ROR 73.4 · χ² 6,907 / p <1e-300 | 69.5 EB05 58.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=102 · ♀ 100% (drug 73%) · 90% clinician | no trial arm names this drug |
| Iodine allergy | 10 | 70.8 37.7–132.8ROR 70.9 · χ² 601 / p 5e-133 | 61.1 EB05 35.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial arm names this drug |
| Immunodeficiency | 391 | 62.4 56.6–68.9ROR 65.2 · χ² 22,948 / p <1e-300 | 60.6 EB05 55.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 59.8 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Coeliac disease | 235 | 56.1 49.4–63.8ROR 57.6 · χ² 12,369 / p <1e-300 | 54.6 EB05 49.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 61.8 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Bursitis | 247 | 47.8 42.2–54.2ROR 49.1 · χ² 11,051 / p <1e-300 | 46.7 EB05 42.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 50.0 · ♀ 98% (drug 73%) | no trial arm names this drug |
| Learning disability | 110 | 47.6 39.5–57.5ROR 48.2 · χ² 4,873 / p <1e-300 | 46.3 EB05 39.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 49% (drug 73%) · 100% consumer | no trial arm names this drug |
| Aortic calcification | 12 | 47.5 26.8–84.0ROR 47.5 · χ² 490 / p 7e-109 | 43.5 EB05 26.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Bronchitis chronic | 49 | 46.5 35.1–61.7ROR 46.8 · χ² 2,096 / p <1e-300 | 44.9 EB05 35.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Prescribed overdose | 372 | 44.9 40.6–49.6ROR 46.7 · χ² 15,611 / p <1e-300 | 43.9 EB05 40.3 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 67.3 · ♀ 100% (drug 73%) | no trial arm names this drug |
| Sedation | 448 | 40.0 36.5–43.8ROR 42.0 · χ² 16,728 / p <1e-300 | 39.3 EB05 36.3 · IC025 +5.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 48.9 · ♀ 3% (drug 73%) | no trial arm names this drug |
| Drug hypersensitivity | 3,275 | 39.3 38.2–40.4ROR 60.5 · χ² 121,094 / p <1e-300 | 38.6 EB05 37.5 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.7 | no trial arm names this drug |
| Primary sequestrum | 15 | 38.0 22.8–63.3ROR 38.1 · χ² 496 / p 4e-110 | 35.9 EB05 23.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Pleural fibrosis | 16 | 36.1 22.0–59.1ROR 36.2 · χ² 503 / p 9e-112 | 34.2 EB05 22.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Iron deficiency | 68 | 35.5 28.0–45.1ROR 35.8 · χ² 2,214 / p <1e-300 | 34.7 EB05 28.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=68 · 93% clinician | no trial arm names this drug |
| Oesophagitis ulcerative | 10 | 33.9 18.1–63.2ROR 33.9 · χ² 283 / p 1e-63 | 31.5 EB05 18.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Dactylitis | 14 | 33.1 19.5–56.1ROR 33.2 · χ² 399 / p 6e-89 | 31.4 EB05 19.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Lupus vulgaris | 16 | 31.2 19.0–51.0ROR 31.2 · χ² 432 / p 4e-96 | 29.8 EB05 19.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Nightmare | 446 | 29.7 27.2–32.6ROR 31.2 · χ² 12,219 / p <1e-300 | 29.3 EB05 27.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.0 · ♀ 4% (drug 73%) | no trial arm names this drug |
| Upper respiratory tract infection (cold/sinus infection) | 583 | 29.3 27.1–31.7ROR 31.2 · χ² 15,726 / p <1e-300 | 28.9 EB05 27.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 44.4 · ♀ 99% (drug 73%) | no trial arm names this drug |
| Systemic lupus erythematosus rash | 10 | 28.9 15.5–53.9ROR 28.9 · χ² 239 / p 3e-54 | 27.1 EB05 15.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Developmental delay | 111 | 28.3 23.5–34.0ROR 28.6 · χ² 2,857 / p <1e-300 | 27.8 EB05 23.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 · ♀ 44% (drug 73%) · 97% consumer | no trial arm names this drug |
| Oedema mucosal | 12 | 26.5 15.0–46.8ROR 26.5 · χ² 267 / p 3e-60 | 25.2 EB05 15.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Vascular calcification | 12 | 25.9 14.6–45.7ROR 25.9 · χ² 259 / p 1e-58 | 24.6 EB05 14.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Cardiac aneurysm | 11 | 25.6 14.2–46.4ROR 25.7 · χ² 234 / p 5e-53 | 24.3 EB05 14.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Perirectal abscess | 12 | 24.9 14.1–43.9ROR 24.9 · χ² 249 / p 2e-56 | 23.7 EB05 14.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Contraindicated product administered | 294 | 22.5 20.1–25.2ROR 23.2 · χ² 5,975 / p <1e-300 | 22.3 EB05 20.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 24.9 · ♀ 99% (drug 73%) | no trial arm names this drug |
| Postictal state | 10 | 22.3 12.0–41.6ROR 22.4 · χ² 181 / p 1e-41 | 20.9 EB05 11.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Meperidine only as a background or rescue medication (NCT02625181); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 3,275 | 39.3 38.2–40.4ROR 60.5 · χ² 121,094 / p <1e-300 | 38.6 EB05 37.5 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.7 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,352 | 2.4 2.2–2.5ROR 2.6 · χ² 1,119 / p 1e-245 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 | no trial arm names this drug |
| Pain | 1,279 | 4.8 4.5–5.0ROR 5.4 · χ² 3,910 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 | no trial arm names this drug |
| Nausea | 1,228 | 3.6 3.4–3.8ROR 4.0 · χ² 2,351 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial arm names this drug |
| Off label use (used outside approved label) | 963 | 2.5 2.4–2.7ROR 2.7 · χ² 937 / p 4e-206 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial arm names this drug |
| Hyperhidrosis (excessive sweating) | 928 | 16.6 15.6–17.6ROR 18.3 · χ² 13,562 / p <1e-300 | 16.5 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 | no trial arm names this drug |
| Drug intolerance | 814 | 19.5 18.3–20.8ROR 21.3 · χ² 14,226 / p <1e-300 | 19.4 EB05 18.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 27.4 · ♀ 98% (drug 73%) | no trial arm names this drug |
| Rash | 798 | 4.2 3.9–4.5ROR 4.5 · χ² 1,994 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · ♀ 94% (drug 73%) | no trial arm names this drug |
| Vomiting | 751 | 3.7 3.4–3.9ROR 3.9 · χ² 1,488 / p <1e-300 | 3.7 EB05 3.4 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial arm names this drug |
| Overdose | 746 | 7.9 7.4–8.5ROR 8.5 · χ² 4,525 / p <1e-300 | 7.9 EB05 7.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial arm names this drug |
| Hypertension (high blood pressure) | 723 | 7.8 7.3–8.4ROR 8.4 · χ² 4,329 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial arm names this drug |
| Headache | 684 | 2.5 2.3–2.7ROR 2.6 · χ² 634 / p 4e-140 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial arm names this drug |
| Pyrexia (fever) | 656 | 4.3 4.0–4.7ROR 4.6 · χ² 1,710 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial arm names this drug |
| Fatigue (tiredness) | 627 | 1.8 1.7–2.0ROR 1.9 · χ² 252 / p 4e-57 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.0 | no trial arm names this drug |
| Joint swelling | 599 | 11.4 10.6–12.4ROR 12.2 · χ² 5,697 / p <1e-300 | 11.4 EB05 10.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 98% (drug 73%) | no trial arm names this drug |
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.
- Temperature regulation disorder — n=271, PRR 324.5
- Contrast media allergy — n=178, PRR 252.6
- Bloody discharge — n=106, PRR 232.4
- Obliterative bronchiolitis — n=83, PRR 152.9
- Food allergy — n=383, PRR 122.3
- Foetal death — n=258, PRR 119.9
- Vision abnormal neonatal — n=20, PRR 113.5
- Lyme disease — n=102, PRR 72.6
- Immunodeficiency — n=391, PRR 62.4
- Coeliac disease — n=235, PRR 56.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Meperidine ↔ Convulsion.
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 Meperidine?
In FDA FAERS, the most frequently co-reported reaction terms for Meperidine are drug hypersensitivity, pain, nausea, hyperhidrosis, rash, vomiting. 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 Meperidine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution.
Do FAERS signals prove that Meperidine 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 15bc51a8-1e24-4d33-9a2f-05a41c29acf0, effective 20260227; matched on
openfda.generic_name.exact:"MEPERIDINE HYDROCHLORIDE") - 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, 1,090 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
MEPERIDINE, results-bearing studies sorted by enrollment)
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.