Oxycodone vs Hydrocodone Bitartrate and Acetaminophen: side effects in FDA adverse event reports
At a glance
| Oxycodone | Hydrocodone Bitartrate and Acetaminophen | |
|---|---|---|
| Drug class | – | – |
| Brand names | Oxycodone Hydrochloride | Hydrocodone Bitartrate |
| FAERS reports | 185,825 | 56,016 |
| Serious | 82% | 86% |
| Death outcome | 53,015 | 8,227 |
| 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 HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of hydrocodone bitar |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
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 Hydrocodone Bitartrate and Acetaminophen
- Drug withdrawal syndrome — n=5,345, PRR 24.0 Labeled adverse reaction
- Drug withdrawal syndrome neonatal — n=2,213, PRR 65.0 Labeled (related wording)
- Mental disorder — n=1,496, PRR 13.3 Labeled adverse reaction
- Congenital anomaly — n=389, PRR 19.6 Labeled (related wording)
- Drug tolerance — n=286, PRR 22.3 Labeled (related wording)
- Substance use disorder — n=107, PRR 13.5 Labeled adverse reaction
- Multiple congenital abnormalities — n=91, PRR 24.9 Labeled (related wording)
- Drug tolerance increased — n=67, PRR 34.9 Labeled (related wording)
Common questions
Which has more reported side effects, Oxycodone or Hydrocodone Bitartrate and Acetaminophen?
Oxycodone has 185,825 FAERS reports and Hydrocodone Bitartrate and Acetaminophen 56,016. 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 86%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Oxycodone and Hydrocodone Bitartrate and Acetaminophen share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Oxycodone or Hydrocodone Bitartrate and Acetaminophen 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.