Skip to main content
PlainMeds

What the label lists and what reports show

Acetaminophen and codeine side effects

Acetaminophen and codeine's FDA label lists its adverse reactions in its own words. FAERS holds 14,001 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 (3,704 reports).

  • Generic listed
  • Boxed warning
  • DEA Schedule II

Check it at the source: the acetaminophen and codeine FDA label on DailyMed (effective June 12, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse ( see WARNINGS ) Life-Threatening Respiratory Depression ( see WARNINGS ) Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children ( see WARNINGS ) Neonatal Opioid Withdrawal Syndrome ( see WARNINGS ) Interactions with CNS Depressants ( see WARNINGS ) Opioid-Induced Hyperalgesia and Allodynia ( see WARNINGS ) Severe Hypotension ( see WARNINGS ) Gastrointestinal Adverse Reactions ( see WARNINGS ) Seizures ( see WARNINGS ) Withdrawal ( see WARNINGS ) The following adverse reactions associated with the use of codeine were identified in postmarketing reports. …

Source: FDA drug label, SpecGx LLC, effective June 12, 2026 (SPL set eadc80fa-13c3-471a-a22f-6fe7e1ab290f), via openFDA; the full label on DailyMed

What do FAERS reports show?

14,001 reports list acetaminophen and codeine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,616 are coded as a death and 4,768 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 (4,202, against a median of 708 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 3 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)3,704
  • Overdose (a use or a product term, not a reaction)2,158
  • Pain (a use or a product term, not a reaction)2,101
  • Fatigue (named in the label)2,036
  • Drug Ineffective (a use or a product term, not a reaction)2,018
  • Arthralgia1,823
  • Rash (named in the label)1,704
  • Rheumatoid Arthritis1,699
  • Off Label Use (a use or a product term, not a reaction)1,679
  • Confusional State1,641
  • Joint Swelling1,614
  • Dyspnoea1,555
  • Blister1,524
  • Arthropathy1,519
  • Alopecia1,509
  • Hepatic Enzyme Increased1,504
  • Nasopharyngitis1,499
  • Duodenal Ulcer Perforation1,495
  • Peripheral Swelling1,495
  • Drug Intolerance1,490
  • Abdominal Discomfort1,482
  • Helicobacter Infection1,481
  • Hypersensitivity1,477
  • Infusion Related Reaction1,474
  • Swelling1,468

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

What next?

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