← All drugs
Drug · FAERS side-effect profile with label screen

Acetaminophen and Codeine side effects: what 12,111 FDA adverse event reports show

Acetaminophen And Codeine · 1,066 reaction terms · 182,337 drug–reaction co-reports · data 2026-09-14
Share: X Facebook Reddit Email

Drug class

Not stated in label

Label matched

Acetaminophen (Acetaminophen)

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

Who reports

12,111 reports · 92% serious · 3,267 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

FDA label, Indications and Usage

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

Lab value / disease marker 8Not in label — unassessed 32
What the badges mean

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. 1,026 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Thiopurine methyltransferase decreased11816.6
398.2–1,674.8ROR 817.3 · χ² 5,522 / p <1e-300
282.0 EB05 168.0 · IC025 +3.4
3/3 methods agree
Lab value / disease markerserious n=11no trial arm names this drug
Hepatic enzyme40696.9
482.7–1,006.2ROR 699.2 · χ² 19,248 / p <1e-300
400.1 EB05 306.5 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=40 · ♀ 100% (drug 68%) · 100% clinicianno trial arm names this drug
Subcutaneous drug absorption impaired144624.0
516.0–754.6ROR 631.5 · χ² 65,145 / p <1e-300
431.0 EB05 375.1 · IC025 +7.2
3/3 methods agree
Not in label — unassessedserious n=144 · ♀ 100% (drug 68%) · 97% clinicianno trial arm names this drug
Facet joint syndrome779570.1
526.8–617.1ROR 609.2 · χ² 331,408 / p <1e-300
423.2 EB05 398.8 · IC025 +8.3
3/3 methods agree
Not in label — unassessedserious n=779 · ♀ 100% (drug 68%) · 96% clinicianno trial arm names this drug
Vaginal flatulence67486.8
371.3–638.2ROR 489.5 · χ² 24,899 / p <1e-300
342.0 EB05 278.6 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=67 · ♀ 100% (drug 68%)no trial arm names this drug
Duodenal ulcer perforation1,491442.4
419.1–467.0ROR 504.3 · χ² 521,312 / p <1e-300
350.0 EB05 335.3 · IC025 +8.2
3/3 methods agree
Not in label — unassessedserious PRR 219.0 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Computerised tomogram thorax12426.9
226.8–803.4ROR 427.3 · χ² 3,745 / p <1e-300
221.6 EB05 135.1 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=12no trial arm names this drug
Swollen joint count48420.3
306.6–576.1ROR 422.0 · χ² 15,777 / p <1e-300
297.5 EB05 233.3 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious n=48 · ♀ 100% (drug 68%) · 94% clinicianno trial arm names this drug
Deep vein thrombosis postoperative382419.7
375.8–468.8ROR 433.4 · χ² 127,760 / p <1e-300
331.5 EB05 304.5 · IC025 +7.7
3/3 methods agree
Not in label — unassessedserious n=382 · ♀ 100% (drug 68%)no trial arm names this drug
Adjustment disorder with depressed mood391417.5
374.4–465.7ROR 431.4 · χ² 130,224 / p <1e-300
330.2 EB05 303.7 · IC025 +7.7
3/3 methods agree
Not in label — unassessedserious n=391 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
X-ray abnormal342411.2
365.9–462.1ROR 423.1 · χ² 112,471 / p <1e-300
325.6 EB05 297.6 · IC025 +7.6
3/3 methods agree
Lab value / disease markerserious n=342 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
C-reactive protein172405.6
343.8–478.5ROR 411.5 · χ² 55,774 / p <1e-300
316.4 EB05 278.7 · IC025 +7.1
3/3 methods agree
Lab value / disease markerserious n=172 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Rheumatic fever822402.2
373.5–433.0ROR 431.4 · χ² 265,956 / p <1e-300
323.2 EB05 305.1 · IC025 +8.0
3/3 methods agree
Not in label — unassessedserious n=822 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive1,334400.9
378.8–424.4ROR 450.4 · χ² 430,807 / p <1e-300
323.4 EB05 309.1 · IC025 +8.1
3/3 methods agree
Lab value / disease markerserious PRR 203.4 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Lupus vulgaris214380.2
328.2–440.5ROR 387.0 · χ² 65,892 / p <1e-300
302.7 EB05 270.2 · IC025 +7.3
3/3 methods agree
Not in label — unassessedserious n=214 · ♀ 100% (drug 68%) · 91% clinicianno trial arm names this drug
Swollen joint count increased549370.5
338.4–405.6ROR 388.1 · χ² 165,961 / p <1e-300
301.4 EB05 280.8 · IC025 +7.8
3/3 methods agree
Lab value / disease markerserious n=549 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
Dislocation of vertebra384361.8
324.6–403.4ROR 373.7 · χ² 113,732 / p <1e-300
294.4 EB05 270.5 · IC025 +7.6
3/3 methods agree
Not in label — unassessedserious n=384 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Peripheral venous disease682357.2
329.5–387.2ROR 378.5 · χ² 200,082 / p <1e-300
293.1 EB05 275.1 · IC025 +7.8
3/3 methods agree
Not in label — unassessedserious n=682 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
Grip strength39350.5
248.4–494.4ROR 351.6 · χ² 10,988 / p <1e-300
254.7 EB05 194.4 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious n=39 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Anti-cyclic citrullinated peptide antibody109338.4
275.7–415.3ROR 341.4 · χ² 30,321 / p <1e-300
269.2 EB05 229.4 · IC025 +6.6
3/3 methods agree
Lab value / disease markerserious n=109 · ♀ 100% (drug 68%) · 94% clinicianno trial arm names this drug
Muscle injury1,333336.3
318.0–355.6ROR 377.8 · χ² 372,156 / p <1e-300
280.0 EB05 267.6 · IC025 +7.9
3/3 methods agree
Not in label — unassessedserious PRR 190.0 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Hypocholesterolaemia48320.1
235.3–435.5ROR 321.4 · χ² 12,593 / p <1e-300
243.6 EB05 191.1 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=48 · ♀ 100% (drug 68%) · 100% clinicianno trial arm names this drug
Helicobacter infection1,478294.0
279.0–309.8ROR 334.7 · χ² 368,102 / p <1e-300
250.1 EB05 239.6 · IC025 +7.8
3/3 methods agree
Not in label — unassessedserious PRR 165.5 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Folliculitis1,447282.4
267.9–297.7ROR 320.6 · χ² 348,119 / p <1e-300
241.7 EB05 231.4 · IC025 +7.7
3/3 methods agree
Not in label — unassessedserious PRR 177.7 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Sleep disorder due to general medical condition, insomnia type841260.4
242.7–279.4ROR 279.8 · χ² 188,407 / p <1e-300
224.9 EB05 212.5 · IC025 +7.5
3/3 methods agree
Not in label — unassessedserious n=841 · ♀ 99% (drug 68%) · 90% clinicianno trial arm names this drug
Rheumatoid factor positive687234.2
216.7–253.2ROR 248.3 · χ² 140,131 / p <1e-300
204.9 EB05 192.4 · IC025 +7.4
3/3 methods agree
Lab value / disease markerserious n=687 · ♀ 100% (drug 68%) · 95% clinicianno trial arm names this drug
Pemphigus1,430225.2
213.8–237.3ROR 255.3 · χ² 282,008 / p <1e-300
198.6 EB05 190.1 · IC025 +7.5
3/3 methods agree
Not in label — unassessedserious PRR 124.6 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Breast cancer stage iii702212.2
196.6–229.0ROR 225.2 · χ² 131,095 / p <1e-300
187.9 EB05 176.5 · IC025 +7.3
3/3 methods agree
Not in label — unassessedserious n=702 · ♀ 100% (drug 68%) · 96% clinicianno trial arm names this drug
Hand deformity1,406208.6
198.0–219.9ROR 235.9 · χ² 258,867 / p <1e-300
185.6 EB05 177.6 · IC025 +7.4
3/3 methods agree
Not in label — unassessedserious PRR 126.2 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Vascular malformation22199.8
128.5–310.6ROR 200.2 · χ² 3,720 / p <1e-300
155.1 EB05 108.0 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=22 · ♀ 100% (drug 68%)no trial arm names this drug
Retinitis171197.7
168.9–231.4ROR 200.5 · χ² 29,816 / p <1e-300
173.9 EB05 153.1 · IC025 +6.6
3/3 methods agree
Not in label — unassessedserious n=171 · ♀ 100% (drug 68%) · 91% clinicianno trial arm names this drug
C-reactive protein abnormal638191.6
176.9–207.5ROR 202.2 · χ² 108,617 / p <1e-300
171.5 EB05 160.6 · IC025 +7.1
3/3 methods agree
Lab value / disease markerserious n=638 · ♀ 100% (drug 68%) · 93% clinicianno trial arm names this drug
Paranasal cyst22174.7
112.7–270.8ROR 175.0 · χ² 3,291 / p <1e-300
139.6 EB05 97.2 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=22 · ♀ 100% (drug 68%)no trial arm names this drug
Pericarditis1,428162.3
154.2–170.9ROR 183.9 · χ² 209,117 / p <1e-300
148.0 EB05 141.7 · IC025 +7.1
3/3 methods agree
Not in label — unassessedserious PRR 93.3 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Porphyria acute115157.3
130.1–190.3ROR 158.8 · χ² 16,215 / p <1e-300
140.8 EB05 120.5 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=115 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Blepharospasm512155.7
142.5–170.2ROR 162.6 · χ² 72,021 / p <1e-300
142.1 EB05 132.0 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious n=510 · ♀ 100% (drug 68%) · 96% clinicianno trial arm names this drug
Lip dry736155.0
144.0–166.8ROR 165.0 · χ² 103,139 / p <1e-300
141.7 EB05 133.3 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious n=734 · ♀ 100% (drug 68%) · 96% clinicianno trial arm names this drug
Bursitis954148.7
139.5–158.5ROR 161.3 · χ² 128,687 / p <1e-300
136.5 EB05 129.4 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious PRR 100.5 · ♀ 100% (drug 68%) · 96% clinicianno trial arm names this drug
Synovitis1,392144.7
137.5–152.4ROR 163.4 · χ² 183,211 / p <1e-300
133.3 EB05 127.5 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious PRR 87.2 · ♀ 99% (drug 68%) · 92% clinicianno trial arm names this drug
Onychomadesis309139.1
124.1–156.0ROR 142.8 · χ² 39,064 / p <1e-300
127.7 EB05 116.2 · IC025 +6.5
3/3 methods agree
Not in label — unassessedserious n=309 · ♀ 100% (drug 68%) · 98% clinicianno trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Acetaminophen and Codeine only as a background or rescue medication (NCT03472469, NCT04452344); 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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Dependence3,690123.2
119.8–126.7ROR 176.8 · χ² 418,192 / p <1e-300
114.9 EB05 111.8 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious PRR 72.2 · ♀ 45% (drug 68%) · 100% consumerno trial arm names this drug
Overdose2,12517.1
16.5–17.8ROR 20.6 · χ² 32,300 / p <1e-300
17.0 EB05 16.4 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious PRR 13.3 · ♀ 47% (drug 68%) · 90% consumerno trial arm names this drug
Pain2,0585.8
5.6–6.0ROR 6.8 · χ² 8,404 / p <1e-300
5.8 EB05 5.6 · IC025 +2.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 5.5 · ♀ 92% (drug 68%)no trial arm names this drug
Fatigue (tiredness)1,9954.5
4.3–4.6ROR 5.1 · χ² 5,533 / p <1e-300
4.4 EB05 4.3 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious PRR 5.1 · ♀ 95% (drug 68%)no trial arm names this drug
Drug ineffective (drug did not work)1,9902.6
2.5–2.7ROR 2.9 · χ² 2,120 / p <1e-300
2.6 EB05 2.5 · IC025 +1.3
3/3 methods agree
Reporting / coding artifactserious PRR 4.4 · ♀ 93% (drug 68%)no trial arm names this drug
Arthralgia (joint pain)1,7857.5
7.2–7.8ROR 8.6 · χ² 10,183 / p <1e-300
7.4 EB05 7.2 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious PRR 8.4 · ♀ 96% (drug 68%)no trial arm names this drug
Rheumatoid arthritis1,68626.2
25.0–27.4ROR 30.3 · χ² 40,432 / p <1e-300
25.8 EB05 24.8 · IC025 +4.6
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious PRR 19.7 · ♀ 99% (drug 68%) · 92% clinicianno trial arm names this drug
Off label use (used outside approved label)1,6733.3
3.2–3.5ROR 3.7 · χ² 2,856 / p <1e-300
3.3 EB05 3.2 · IC025 +1.7
3/3 methods agree
Reporting / coding artifactserious PRR 3.8 · ♀ 93% (drug 68%)no trial arm names this drug
Rash1,6476.6
6.3–6.9ROR 7.5 · χ² 7,951 / p <1e-300
6.6 EB05 6.3 · IC025 +2.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 9.0 · ♀ 97% (drug 68%)no trial arm names this drug
Joint swelling1,60123.3
22.3–24.4ROR 26.7 · χ² 33,895 / p <1e-300
23.0 EB05 22.1 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious PRR 24.6 · ♀ 98% (drug 68%) · 90% clinicianno trial arm names this drug
Confusional state (confusion)1,60017.3
16.5–18.1ROR 19.7 · χ² 24,454 / p <1e-300
17.1 EB05 16.4 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 13.6 · ♀ 97% (drug 68%) · 91% clinicianno trial arm names this drug
Arthropathy1,51548.3
46.1–50.7ROR 55.1 · χ² 68,408 / p <1e-300
47.0 EB05 45.0 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious PRR 35.7 · ♀ 99% (drug 68%) · 91% clinicianno trial arm names this drug
Blister1,51148.0
45.7–50.3ROR 54.7 · χ² 67,730 / p <1e-300
46.7 EB05 44.7 · IC025 +5.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 48.1 · ♀ 99% (drug 68%) · 93% clinicianno trial arm names this drug
Hepatic enzyme increased1,50239.1
37.3–41.0ROR 44.5 · χ² 54,677 / p <1e-300
38.2 EB05 36.6 · IC025 +5.2
3/3 methods agree
Lab value / disease markerserious PRR 34.4 · ♀ 100% (drug 68%) · 92% clinicianno trial arm names this drug
Nasopharyngitis (common cold)1,49814.1
13.5–14.8ROR 16.0 · χ² 18,300 / p <1e-300
14.0 EB05 13.4 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 19.4 · ♀ 99% (drug 68%) · 91% clinicianno 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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Acetaminophen (paracetamol) ↔ Liver injury / hepatotoxicity.

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 Acetaminophen and Codeine?

In FDA FAERS, the most frequently co-reported reaction terms for Acetaminophen and Codeine are dependence, pain, fatigue, arthralgia, rheumatoid arthritis, rash. 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 Acetaminophen and Codeine have an FDA boxed warning?

No. The FDA label retrieved for Acetaminophen and Codeine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Acetaminophen and 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

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.