pharmacopeia
GET
/api/v1/drug/acetaminophen
2D structure
N-(4-hydroxyphenyl)acetamide
SMILES CC(=O)NC1=CC=C(C=C1)O
InChIKey RZVAJINKPMORJF-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Prostaglandin Receptor Antagonists.

Prostaglandin Receptor

Indications

Sourced from openFDA
  • Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces feverICD-10: J00, R50.9, R51.9

Dosage & administration

Sourced from openFDA

Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Warnings & precautions

Sourced from openFDA

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Approval history

Sourced from openFDA
  • Apr 22, 1980NDANDA018337Taro
  • Jul 30, 1992NDANDA020232Actavis Labs Ut Inc
  • Jun 8, 1994NDANDA019872Kenvue Brands
  • Jan 14, 1998NDANDA020802Haleon Us Holdings
  • Oct 28, 2015NDANDA204767Fresenius Kabi Usa
  • Feb 23, 2018NDANDA208653Zevra Therap
  • Feb 28, 2020NDANDA211733Haleon Us Holdings
  • Jun 3, 2022NDANDA206968Hikma

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 10 mg (NDC 60951-712-70)To be discontinued
    Sponsor: Endo Pharmaceuticals, Inc.
    Updated
  • Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 2.5 mg (NDC 60951-701-70)To be discontinued
    Sponsor: Endo Pharmaceuticals, Inc.
    Updated
  • Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 5 mg (NDC 60951-602-70)To be discontinued
    Sponsor: Endo Pharmaceuticals, Inc.
    Updated
  • Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 5 mg (NDC 60951-602-85)To be discontinued
    Sponsor: Endo Pharmaceuticals, Inc.
    Updated
  • Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 7.5 mg (NDC 60951-700-70)To be discontinued
    Sponsor: Endo Pharmaceuticals, Inc.
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
668,257 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective51,4527.7%
  2. 2Pain48,8597.3%
  3. 3Fatigue44,9016.7%
  4. 4Nausea40,9816.1%
  5. 5Overdose40,4956.1%
  6. 6Drug Dependence39,1595.9%
  7. 7Off Label Use38,6085.8%
  8. 8Headache37,9025.7%
  9. 9Death36,2055.4%
  10. 10Diarrhoea31,6004.7%
  11. 11Dyspnoea30,1134.5%
  12. 12Toxicity To Various Agents27,5744.1%
  13. 13Vomiting27,4484.1%
  14. 14Arthralgia27,3714.1%
  15. 15Dizziness23,9613.6%

Literature

View JSON

Recent PubMed references pinned to Acetaminophen as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 2,049 ClinicalTrials.gov registrations naming Acetaminophen as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Acetaminophen work?
Mechanism-of-action class: Prostaglandin Receptor Antagonists.
What is Acetaminophen used for?
According to FDA labeling, Acetaminophen carries indications including: Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acetaminophen?
Acetaminophen is classified as Anilides, Prostaglandin Receptor Antagonists, Central Nervous System Activity Alteration, Decreased Prostaglandin Production, Hypothalamic Endocrine Activity Alteration, Peripheral Nervous System Activity Alteration.
What are the brand names for Acetaminophen?
Acetaminophen is marketed under brand names including Acephen, Acetadryl, Allzital, Anabar, Anacin AF, Anacin Advanced Headache Formula, Apadaz, Arthriten Inflammatory Pain.
Note. Data for acetaminophen is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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