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Codeine Side Effects

The most commonly reported side effects of codeine include dependence, nausea, and headache, based on 34,020 FDA adverse event reports from 2004 to 2025. 5.7% of reports found the drug to be ineffective.

Codeine side effects

Percentages show how often each reaction appears relative to total reports for codeine.

1
Dependence10.4%3,549
2
Nausea6.5%2,227
3
Headache6.1%2,071
4
Fatigue5.7%1,949
5
Drug Ineffective5.7%1,926
6
Pain5.4%1,853
7
Diarrhoea5.0%1,691
8
Arthralgia4.4%1,487
9
Drug Hypersensitivity4.3%1,476
10
Vomiting4.3%1,456
11
Dyspnoea4.2%1,426
12
Off Label Use3.9%1,342
13
Malaise3.9%1,313
14
Dizziness3.7%1,258
15
Rash3.5%1,203

These are voluntary reports and do not establish that codeine caused these reactions.

Report severity

78.7%Serious26,762 reports
31.0%Hospitalizations10,536 reports
12.2%Fatal4,135 reports

Seriousness is determined by the reporter, not by OpenClaim.

Codeine drug interactions

Other drugs that appear in adverse event reports alongside codeine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Acetaminophen15.4%5,245
2
Tramadol-hydrochloride12.2%4,139
3
Promethazine-hydrochloride11.0%3,747
4
Oxymorphone-hydrochloride9.0%3,061
5
Propoxyphene8.3%2,836
6
Oxycodone5.9%2,013
7
Adalimumab5.9%1,995
8
Etanercept4.2%1,427
9
Aspirin4.1%1,384
10
Morphine-sulfate3.5%1,201
11
Infliximab3.5%1,181
12
Caffeine3.4%1,169
13
Tocilizumab3.1%1,067
14
Ibuprofen3.1%1,063
15
Rituximab3.1%1,056

Taken alongside

1
Acetaminophen51.7%17,586
2
Caffeine24.7%8,414
3
Butalbital23.8%8,101
4
Aspirin15.2%5,181
5
Omeprazole11.5%3,912
6
Albuterol11.0%3,756
7
Levothyroxine-sodium9.2%3,139
8
Ergocalciferol9.1%3,111
9
Gabapentin8.3%2,811
10
Ibuprofen7.7%2,609
11
Furosemide7.7%2,604
12
Atorvastatin-calcium7.3%2,492
13
Ondansetron7.1%2,404
14
Prednisone6.8%2,308
15
Oxycodone6.5%2,200

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports codeine side effects

60.7% of codeine adverse event reports involve female patients and 28.5% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.7%
Male28.5%
Unknown10.8%

Age group

< 20.6%
2–110.7%
12–171.2%
18–6463.9%
65+33.5%

What is codeine used for

Conditions and purposes for which patients were taking codeine when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbscessAbscess RuptureAccidental Exposure To ProductAcute Coronary SyndromeAcute LeukaemiaAcute Myocardial InfarctionAdenoidectomyAdenotonsillectomyAdverse Drug ReactionAdverse EventAfterbirth Pain

Showing 15 of 620 indications

Codeine brand names and reporting trend

Codeine is sold under brand names including Triprolidine And Pseudoephedrine Hydrochlorides W/ Codeine, Codeine Sulfate, Tuzistra Xr.

Brand names

Triprolidine And Pseudoephedrine Hydrochlorides W/ Codeine12,122
Codeine Sulfate3,595
Tuzistra Xr8

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking codeine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.