Oxycodone vs Codeine: side effects in FDA adverse event reports
At a glance
| Oxycodone | Codeine | |
|---|---|---|
| Drug class | – | – |
| Brand names | Oxycodone Hydrochloride | Codeine Sulfate |
| FAERS reports | 185,825 | 3,295 |
| Serious | 82% | 64% |
| Death outcome | 53,015 | 798 |
| Boxed warning | Yes SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HCl Addiction, Abuse, and Misuse Because the use of oxycodone HCl exposes patients and other users to t | Yes SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of Codeine Sulfate Tablets exposes patients |
Signals both drugs share
| Reaction | Oxycodone | Codeine | Label screen (A / B) |
|---|---|---|---|
| Folliculitis | 4,193 · PRR 77.1 | 25 · PRR 15.4 | Not in label — unassessed / Not in label — unassessed |
| Synovitis | 3,825 · PRR 30.2 | 33 · PRR 11.7 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 3,679 · PRR 47.2 | 21 · PRR 10.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 3,544 · PRR 60.0 | 21 · PRR 13.1 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Oxycodone
- Glossodynia — n=3,759, PRR 22.7 Labeled (related wording)
- Muscle injury — n=3,699, PRR 92.7 Labeled (related wording)
- Sleep disorder due to general medical condition, insomnia type — n=2,636, PRR 78.2 Labeled (related wording)
- Peripheral venous disease — n=1,261, PRR 51.9 Labeled (related wording)
- Subcutaneous drug absorption impaired — n=220, PRR 76.3 Labeled (related wording)
- Steroid dependence — n=145, PRR 23.1 Labeled (related wording)
Labeled signals distinctive to Codeine
- Drug hypersensitivity — n=815, PRR 26.8 Labeled (related wording)
- Syncope — n=243, PRR 15.5 Labeled adverse reaction
- Coma — n=172, PRR 23.0 Labeled — boxed warning
- Altered state of consciousness — n=166, PRR 49.4 Labeled (related wording)
- Sedation — n=60, PRR 14.7 Labeled — boxed warning
- Obesity — n=31, PRR 12.4 Labeled adverse reaction
- Respiratory depression — n=27, PRR 14.0 Labeled — boxed warning
Common questions
Which has more reported side effects, Oxycodone or Codeine?
Oxycodone has 185,825 FAERS reports and Codeine 3,295. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (82% vs 64%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Oxycodone and Codeine share?
Both drugs carry disproportionality signals for folliculitis, synovitis, pemphigus, helicobacter infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Oxycodone or Codeine safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.