What the label lists and what reports show
Oxycodone side effects
Oxycodone's FDA label: “Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.” FAERS holds 311,625 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug dependence (101,932 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the oxycodone FDA label on DailyMed (effective May 6, 2026, Rhodes Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
Table 3: Incidence of Adverse Reactions Reported in ≥ 5.0% Patients 11 to 16 Years
This table is printed in the OxyContin label published by Knoa Pharma LLC of June 24, 2026; the label quoted above does not print one.
| System Organ Class Preferred Term | 11 to 16 Years (N=140) n (%) |
|---|---|
| Any Adverse Event >= 5% | 71 (51) |
| GASTROINTESTINAL DISORDERS | 56 (40) |
| Vomiting | 30 (21) |
| Nausea | 21 (15) |
| Constipation | 13 (9) |
| Diarrhea | 8 (6) |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 32 (23) |
| Pyrexia | 15 (11) |
| METABOLISM AND NUTRITION DISORDERS | 9 (6) |
| Decreased appetite | 7 (5) |
| NERVOUS SYSTEM DISORDERS | 37 (26) |
| Headache | 20 (14) |
| Dizziness | 12 (9) |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 23 (16) |
| Pruritus | 8 (6) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals LLC at 1-888-873-5329; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Rhodes Pharmaceuticals LLC, effective May 6, 2026 (SPL set a5162476-1217-41c0-bc7e-0a0f123f069f), via openFDA; the full label on DailyMed
What do FAERS reports show?
311,625 reports list oxycodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 74,855 are coded as a death and 71,489 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (61,206, against a median of 14,507 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Oxycodone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions