Drug · FAERS side-effect profile with label screen
Codeine side effects: what 3,295 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Codeine Sulfate (Codeine Sulfate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,295 reports · 64% serious · 798 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: • Because of the risks of addiction, abuse, misuse.
FDA label, Indications and Usage
What it is
Codeine Sulfate Tablets, USP contain codeine, an opioid agonist, available for oral administration containing either 15 mg, 30 mg, or 60 mg of codeine sulfate, USP.
FDA label, Description section
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of Codeine Sulfate Tablets exposes patients and other users to the risks of opioid addiction, abuse,.
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 3Labeled adverse reaction 2Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 28
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 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.
- 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. 227 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 |
|---|---|---|---|---|---|---|
| Ocular discomfort | 168 | 100.0 86.2–116.0ROR 105.3 · χ² 16,117 / p <1e-300 | 97.4 EB05 85.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=166 · 92% clinician | no trial data cached |
| Generalised oedema | 162 | 84.8 72.9–98.7ROR 89.2 · χ² 13,167 / p <1e-300 | 82.9 EB05 72.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 83.4 · 94% clinician | no trial data cached |
| Head discomfort | 163 | 59.4 51.1–69.1ROR 62.5 · χ² 9,226 / p <1e-300 | 58.5 EB05 51.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 93.5 · 93% clinician | no trial data cached |
| Altered state of consciousness | 166 | 49.4 42.6–57.3ROR 52.0 · χ² 7,769 / p <1e-300 | 48.8 EB05 42.8 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 44.5 · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 138 | 47.4 40.2–55.8ROR 49.4 · χ² 6,178 / p <1e-300 | 46.7 EB05 40.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 67.5 · 92% clinician | no trial data cached |
| Deformity | 66 | 45.1 35.5–57.3ROR 46.0 · χ² 2,785 / p <1e-300 | 44.3 EB05 36.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 46.1 · ♀ 100% (drug 69%) | no trial data cached |
| Presyncope (near-fainting) | 162 | 42.9 36.9–49.9ROR 45.1 · χ² 6,548 / p <1e-300 | 42.4 EB05 37.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 48.7 · 94% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 169 | 42.6 36.7–49.3ROR 44.8 · χ² 6,783 / p <1e-300 | 42.1 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 38.9 · 93% clinician | no trial data cached |
| Diplopia (double vision) | 156 | 38.4 33.0–44.8ROR 40.3 · χ² 5,625 / p <1e-300 | 38.1 EB05 33.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 47.0 · 94% clinician | no trial data cached |
| Ascites | 161 | 35.0 30.1–40.7ROR 36.8 · χ² 5,265 / p <1e-300 | 34.7 EB05 30.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 31.7 · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 164 | 30.6 26.3–35.5ROR 32.1 · χ² 4,646 / p <1e-300 | 30.3 EB05 26.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.0 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 195 | 29.6 25.8–33.9ROR 31.4 · χ² 5,349 / p <1e-300 | 29.4 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · ♀ 41% (drug 69%) · 94% clinician | no trial data cached |
| Drug hypersensitivity | 815 | 26.8 25.3–28.5ROR 35.3 · χ² 20,331 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.3 · ♀ 91% (drug 69%) | no trial data cached |
| Contraindicated product administered | 124 | 26.3 22.1–31.2ROR 27.3 · χ² 2,980 / p <1e-300 | 26.1 EB05 22.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 29.0 · ♀ 100% (drug 69%) | no trial data cached |
| Blindness | 164 | 25.7 22.2–29.9ROR 27.0 · χ² 3,866 / p <1e-300 | 25.6 EB05 22.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 · 93% clinician | no trial data cached |
| Musculoskeletal disorder | 71 | 23.7 18.8–29.8ROR 24.2 · χ² 1,516 / p <1e-300 | 23.5 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 32.6 · ♀ 98% (drug 69%) | no trial data cached |
| Coma | 172 | 23.0 19.9–26.7ROR 24.3 · χ² 3,599 / p <1e-300 | 22.9 EB05 20.2 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.7 · 92% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 162 | 22.5 19.3–26.1ROR 23.6 · χ² 3,299 / p <1e-300 | 22.4 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · 93% clinician | no trial data cached |
| Hepatic steatosis | 64 | 22.0 17.2–28.0ROR 22.4 · χ² 1,256 / p 2e-275 | 21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · ♀ 96% (drug 69%) | no trial data cached |
| Red blood cell sedimentation rate increased | 35 | 20.1 14.5–28.0ROR 20.3 · χ² 616 / p 3e-136 | 19.9 EB05 14.9 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 20.5 · ♀ 100% (drug 69%) | no trial data cached |
| Eye pain | 172 | 19.9 17.2–23.0ROR 20.9 · χ² 3,063 / p <1e-300 | 19.8 EB05 17.4 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 39.7 · 90% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 60 | 17.3 13.4–22.2ROR 17.6 · χ² 902 / p 2e-198 | 17.1 EB05 13.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 98% (drug 69%) | no trial data cached |
| Therapeutic product effect decreased | 120 | 17.3 14.5–20.6ROR 17.9 · χ² 1,820 / p <1e-300 | 17.2 EB05 14.7 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 30.3 · ♀ 100% (drug 69%) | no trial data cached |
| Hypercholesterolaemia | 24 | 16.0 10.7–23.8ROR 16.1 · χ² 322 / p 3e-72 | 15.6 EB05 10.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 100% (drug 69%) · 91% clinician | no trial data cached |
| Drug intolerance | 241 | 16.0 14.1–18.0ROR 17.2 · χ² 3,374 / p <1e-300 | 15.9 EB05 14.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 22.4 · ♀ 99% (drug 69%) | no trial data cached |
| Bursitis | 30 | 15.9 11.1–22.7ROR 16.0 · χ² 402 / p 9e-90 | 15.5 EB05 11.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · ♀ 92% (drug 69%) | no trial data cached |
| Wound infection | 27 | 15.8 10.9–23.1ROR 16.0 · χ² 360 / p 1e-80 | 15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 91% (drug 69%) · 92% clinician | no trial data cached |
| Syncope (fainting) | 243 | 15.5 13.7–17.5ROR 16.6 · χ² 3,285 / p <1e-300 | 15.4 EB05 13.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.7 · 91% clinician | no trial data cached |
| Folliculitis | 25 | 15.4 10.4–22.8ROR 15.5 · χ² 323 / p 2e-72 | 15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 95% (drug 69%) · 96% clinician | no trial data cached |
| Sedation | 60 | 14.7 11.4–18.9ROR 14.9 · χ² 750 / p 2e-165 | 14.5 EB05 11.6 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 17.5 · ♀ 16% (drug 69%) | no trial data cached |
| Tachycardia (fast heart rate) | 203 | 14.6 12.8–16.7ROR 15.5 · χ² 2,557 / p <1e-300 | 14.5 EB05 12.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Respiratory depression | 27 | 14.0 9.6–20.5ROR 14.1 · χ² 314 / p 2e-70 | 13.6 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.5 · 93% clinician | no trial data cached |
| Helicobacter infection | 21 | 13.1 8.6–20.1ROR 13.2 · χ² 223 / p 1e-50 | 12.4 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 100% clinician | no trial data cached |
| Hypercalcaemia | 24 | 12.4 8.3–18.5ROR 12.5 · χ² 240 / p 2e-54 | 11.7 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Obesity | 31 | 12.4 8.7–17.6ROR 12.5 · χ² 313 / p 3e-70 | 11.9 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.5 | no trial data cached |
| Synovitis | 33 | 11.7 8.3–16.4ROR 11.8 · χ² 311 / p 8e-70 | 11.1 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Swollen tongue | 55 | 11.2 8.6–14.6ROR 11.4 · χ² 501 / p 2e-111 | 10.9 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 100% (drug 69%) | no trial data cached |
| Joint range of motion decreased | 23 | 11.0 7.3–16.5ROR 11.0 · χ² 198 / p 3e-45 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 100% clinician | no trial data cached |
| Pemphigus | 21 | 10.8 7.0–16.5ROR 10.8 · χ² 176 / p 2e-40 | 9.8 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 187 | 10.7 9.3–12.3ROR 11.3 · χ² 1,637 / p <1e-300 | 10.6 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 815 | 26.8 25.3–28.5ROR 35.3 · χ² 20,331 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.3 · ♀ 91% (drug 69%) | no trial data cached |
| Nausea | 505 | 4.1 3.8–4.4ROR 4.6 · χ² 1,214 / p 3e-266 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Malaise (feeling unwell) | 381 | 5.5 5.0–6.1ROR 6.1 · χ² 1,434 / p <1e-300 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Vomiting | 374 | 5.1 4.6–5.6ROR 5.6 · χ² 1,248 / p 9e-274 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Headache | 373 | 3.8 3.4–4.2ROR 4.1 · χ² 787 / p 2e-173 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 89% (drug 69%) | no trial data cached |
| Arthralgia (joint pain) | 363 | 5.6 5.1–6.1ROR 6.1 · χ² 1,386 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 89% (drug 69%) | no trial data cached |
| Diarrhoea (diarrhea) | 352 | 3.5 3.2–3.8ROR 3.8 · χ² 640 / p 1e-141 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 337 | 3.8 3.4–4.2ROR 4.1 · χ² 709 / p 1e-156 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Cough | 307 | 7.0 6.3–7.8ROR 7.6 · χ² 1,589 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Pain | 287 | 3.0 2.7–3.3ROR 3.2 · χ² 384 / p 8e-86 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.9 · ♀ 92% (drug 69%) | no trial data cached |
| Abdominal pain upper | 271 | 8.4 7.5–9.4ROR 9.1 · χ² 1,776 / p <1e-300 | 8.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.4 · ♀ 94% (drug 69%) | no trial data cached |
| Pruritus (itching) | 270 | 4.5 4.1–5.1ROR 4.9 · χ² 757 / p 6e-167 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Asthenia (weakness) | 261 | 4.4 3.9–5.0ROR 4.7 · χ² 699 / p 2e-154 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Rash | 260 | 3.8 3.4–4.3ROR 4.1 · χ² 549 / p 1e-121 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · ♀ 93% (drug 69%) | no trial data cached |
| Pyrexia (fever) | 252 | 4.6 4.1–5.2ROR 4.9 · χ² 726 / p 3e-160 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | 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.
- Ocular discomfort — n=168, PRR 100.0
- Generalised oedema — n=162, PRR 84.8
- Head discomfort — n=163, PRR 59.4
- Photophobia — n=138, PRR 47.4
- Deformity — n=66, PRR 45.1
- Presyncope — n=162, PRR 42.9
- Haematemesis — n=169, PRR 42.6
- Diplopia — n=156, PRR 38.4
- Ascites — n=161, PRR 35.0
- Haematuria — n=164, PRR 30.6
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 Codeine?
In FDA FAERS, the most frequently co-reported reaction terms for Codeine are drug hypersensitivity, nausea, malaise, vomiting, headache, arthralgia. 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 Codeine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of Codeine Sulfate Tablets exposes patients and other users to the risks of opioid addiction, abuse,.
Do FAERS signals prove that Codeine 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 010905f9-3bcb-4b50-9fe8-a3ad0010f14c, effective 20251222; matched on
openfda.generic_name.exact:"CODEINE SULFATE") - 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, 267 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.