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What the label lists and what reports show

Acetaminophen and oxycodone side effects

Acetaminophen and oxycodone's FDA label lists its adverse reactions in its own words. FAERS holds 23,353 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 dependence (8,736 reports).

  • Generic listed
  • A presentation discontinued
  • Boxed warning
  • DEA Schedule II

Check it at the source: the acetaminophen and oxycodone FDA label on DailyMed (effective December 23, 2025, Aurolife Pharma, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions that may be associated with oxycodone and acetaminophen tablets use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE]. The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in non ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. …

Source: FDA drug label, Aurolife Pharma, LLC, effective December 23, 2025 (SPL set 69df20d9-b1d5-47dc-9ff0-29987284f8c7), via openFDA; the full label on DailyMed

What do FAERS reports show?

23,353 reports list acetaminophen and oxycodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,983 are coded as a death and 4,385 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 2023 (9,274, against a median of 1,209 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, 10 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

  • Dependence (named in the label)8,736
  • Overdose (a use or a product term, not a reaction)4,119
  • Ill-Defined Disorder3,101
  • Drug Ineffective (a use or a product term, not a reaction)1,924
  • Pain (a use or a product term, not a reaction)1,819
  • Death (an outcome recorded in the report)1,688
  • Fatigue (named in the label)1,629
  • Nausea (named in the label)1,446
  • Dyspnoea (named in the label)1,177
  • Withdrawal Syndrome1,148
  • Drug Dependence (named in the label)1,133
  • Arthralgia1,103
  • Off Label Use (a use or a product term, not a reaction)1,064
  • Anxiety (named in the label)1,055
  • Headache (named in the label)1,055
  • Depression974
  • Rash (named in the label)931
  • Diarrhoea (named in the label)920
  • Pruritus (named in the label)902
  • Pyrexia872
  • Peripheral Swelling864
  • Nasopharyngitis843
  • Infection829
  • Joint Swelling826
  • Weight Increased812

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Acetaminophen and oxycodone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions