Acetaminophen
Acetaminophen, Acetaminophen /, Acetaminophen / / Caffeine, Acetaminophen / Butalbital, Acetaminophen / Butalbital / Caffeine, Acetaminophen / Butalbital / Caffeine / Codeine, Acetaminophen / Codeine, Allzital, Anexsia, Apadaz, Butapap, Combogesic, Darvocet, Dhc, Dolene Ap, Drixoral, Excedrin (migraine Relief), Feverall, Fioricet, Oxycet, Percocet, Propacet, Synalgos-dc-a, Talacen, Tavist, Trezix, Tylenol, Tylox, Wygesic (acetaminophen) is a small molecule pharmaceutical. Acetaminophen was first approved as Acephen on 1982-01-01. It is used to treat fever and pain in the USA. It is known to target prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1.
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Commercial
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Acetaminophen, Feverall, Tylenol (discontinued: Acephen, Acetaminophen, Feverall, Injectapap, Neopap, Ofirmev, Tylenol)
CombinationsAcetaminophen codeine, Acetaminophen ibuprofen, Acetaminophen, aspirin caffeine, Advil dual action with acetaminophen, Anexsia, Butalbital acetaminophen, Butalbital, acetaminophen caffeine, Butalbital, acetaminophen, caffeine codeine, Butapap, Combogesic, Excedrin (migraine relief), Fioricet, Hydrocodone acetaminophen, Oxycet, Oxycodone acetaminophen, Percocet, Tramadol acetaminophen (discontinued: Acetaminophen codeine, Acetaminophen hydrocodone, Acetaminophen ibuprofen, Acetaminophen pentazocine, Acetaminophen, caffeine, dihydrocodeine, Allay, Anexsia, Anoquan, Apadaz, Bancap, Bucet, Butalbital acetaminophen, Butalbital, acetaminophen caffeine, Butalbital, acetaminophen, caffeine codeine, Capital codeine, Co-gesic, Codeine, aspirin, apap no., Codrix, Darvocet, Darvocet a500, Darvocet-n, Dhc, Dolene ap, Drixoral, Duradyne dhc, Empracet, Esgic, Femcet, Hydrocodone acetaminophen, Lorcet-hd, Lortab, Norco, Oxycodone, Oxycodone acetaminophen, Percocet, Phenaphen, Phrenilin, Phrenilin with caffeine codeine, Propacet, Propoxyphene acetaminophen, Propoxyphene napsylate acetaminophen, Proval, Roxicet, Roxilox, Talacen, Tavist, Tencon, Tramadol acetaminophen, Trezix, Triad, Tycolet, Tylenol, Tylox, Ultracet, Vicodin, Wygesic, Xartemis, Zydone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetaminophen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACETAMINOPHEN | B. Braun Medical | N-204957 RX | 2021-02-18 | 2 products, RLD, RS |
| ACETAMINOPHEN | Fresenius Kabi | N-204767 RX | 2015-10-28 | 1 products |
| ACETAMINOPHEN | Hikma Pharmaceuticals | N-206968 RX | 2022-06-03 | 1 products, RLD, RS |
| TYLENOL | Johnson & Johnson | N-019872 OTC | 1994-06-08 | 2 products, RLD, RS |
| ACETAMINOPHEN | Taro Pharmaceutical | N-018337 OTC | 1982-01-01 | 2 products, RLD |
| INFANTS' FEVERALL | Taro Pharmaceutical | N-018337 OTC | 1992-08-26 | 1 products, RLD |
Show 7 discontinued
Acetaminophen
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Tramadol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ULTRACET | Johnson & Johnson | N-021123 DISCN | 2001-08-15 | 1 products, RLD |
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Acetaminophen
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Ibuprofen
Acetaminophen
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Clemastine fumarate
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Pseudoephedrine hydrochloride
Acetaminophen
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Pentazocine hydrochloride
Acetaminophen
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Dexbrompheniramine maleate
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Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DRIXORAL PLUS | Merck & Co | N-019453 DISCN | 1987-05-22 | 1 products |
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Acetaminophen
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Oxycodone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XARTEMIS XR | Mallinckrodt | N-204031 DISCN | 2014-03-11 | 1 products, RLD |
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Acetaminophen
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Propoxyphene napsylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DARVOCET-N 50 | Xanodyne Pharmaceuticals | N-017122 DISCN | 1982-01-01 | 1 products |
| DARVOCET-N 100 | Xanodyne Pharmaceuticals | N-017122 DISCN | 1982-01-01 | 1 products |
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Acetaminophen
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Propoxyphene hydrochloride
Acetaminophen
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Aspirin
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Caffeine
Acetaminophen
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Butalbital
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Caffeine
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Codeine phosphate
Acetaminophen
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Benzhydrocodone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| APADAZ | Zevra Therapeutics | N-208653 DISCN | 2018-02-23 | 3 products, RLD |
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Acetaminophen
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Ibuprofen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COMBOGESIC IV | Hikma Pharmaceuticals | N-215320 RX | 2023-10-17 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 8 hour pain relief | ANDA | 2024-07-24 |
| ac fast | OTC monograph not final | 2021-04-02 |
| acephen | ANDA | 2016-03-09 |
| acetaminophen | C200263 | 2024-07-30 |
| acetaminophen - apap 8 hour | ANDA | 2024-12-27 |
| acetaminophen - apap arthritis | ANDA | 2024-12-27 |
| acetaminophen 500 mg | C200263 | 2024-07-16 |
| acetaminophen and codeine | ANDA | 2024-07-25 |
| acetaminophen and codeine phosphate | ANDA | 2024-07-31 |
| acetaminophen-apap 8 hour | ANDA | 2013-01-17 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ACETAMINOPHEN / IBUPROFEN, COMBOGESIC, AFT PHARMS LTD | |||
| 2026-03-01 | NP | ||
ACETAMINOPHEN / IBUPROFEN, ADVIL DUAL ACTION WITH ACETAMINOPHEN, GLAXOSMITHKLINE | |||
| 2023-02-28 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Acetaminophen / Ibuprofen, Combogesic, Aft Pharms Ltd | |||
| 11197830 | 2039-02-27 | DP | U-3553 |
| 11534407 | 2039-02-27 | DP | U-3553 |
| 10532036 | 2025-09-22 | U-3553 | |
| Acetaminophen / Oxycodone Hydrochloride, Xartemis Xr, Mallinckrodt Inc | |||
| 8658631 | 2032-05-16 | DP | |
| 8741885 | 2032-05-16 | DP | U-1499 |
| 8992975 | 2032-05-16 | DP | |
| 9050335 | 2032-05-16 | DP | |
| 9468636 | 2032-05-16 | U-1499 | |
| 8597681 | 2030-12-21 | DP | |
| 8980319 | 2030-12-21 | DP | |
| 8377453 | 2029-11-19 | DP | U-1499 |
| 8372432 | 2029-03-11 | DP | U-1499 |
| 8394408 | 2029-03-11 | DP | |
| 8668929 | 2029-03-11 | U-1499 | |
| 7976870 | 2027-06-01 | U-1498 | |
| Acetaminophen, Ofirmev, Mallinckrodt Hosp | |||
| 9399012 | 2031-09-11 | U-2261, U-2262 | |
| 9610265 | 2028-11-13 | U-2263 | |
| 9987238 | 2028-11-13 | U-2261 | |
| 10383834 | 2028-11-13 | U-2262, U-2621 | |
| Acetaminophen / Benzhydrocodone Hydrochloride, Apadaz, Zevra Therap | |||
| 8461137 | 2031-02-22 | DS, DP | |
| 8748413 | 2030-07-10 | DS, DP | |
| 8828978 | 2030-07-01 | DP | |
| 9132125 | 2030-07-01 | DS, DP | U-2249 |
| 9549923 | 2030-07-01 | DS, DP | |
| Acetaminophen, Acetaminophen, Fresenius Kabi Usa | |||
| 8741959 | 2030-04-19 | DP | |
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ01: Dihydrocodeine and paracetamol
— N02AJ06: Codeine and paracetamol
— N02AJ13: Tramadol and paracetamol
— N02AJ17: Oxycodone and paracetamol
— N02B: Other analgesics and antipyretics in atc
— N02BE: Anilide analgesics and antipyretics
— N02BE01: Paracetamol
— N02BE51: Paracetamol, combinations excl. psycholeptics
— N02BE71: Paracetamol, combinations with psycholeptics
HCPCS
Code | Description |
|---|---|
| J0131 | Injection, acetaminophen, 10 mg |
Clinical
Clinical Trials
2657 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 16 | 31 | 67 | 163 | 205 | 475 |
| Pain | D010146 | EFO_0003843 | R52 | 23 | 31 | 46 | 82 | 88 | 264 |
| Agnosia | D000377 | EFO_0007136 | F88 | 4 | 16 | 19 | 32 | 54 | 119 |
| Acute pain | D059787 | — | R52 | 6 | 13 | 20 | 26 | 37 | 101 |
| Healthy volunteers/patients | — | — | — | 53 | 1 | 1 | 6 | 11 | 71 |
| Analgesia | D000698 | — | — | 5 | 3 | 9 | 18 | 37 | 71 |
| Low back pain | D017116 | — | M54.5 | 1 | 3 | 16 | 15 | 35 | 70 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 5 | 6 | 15 | 19 | 25 | 68 |
| Fever | D005334 | — | R50.9 | 5 | 7 | 12 | 20 | 16 | 58 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 2 | 1 | 3 | 4 | 44 | 53 |
Show 387 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 10 | 16 | 2 | — | 1 | 26 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 7 | 8 | 2 | — | 1 | 16 |
| Plasma cell neoplasms | D054219 | — | — | 4 | 5 | 1 | — | 1 | 11 |
| Liver failure | D017093 | — | K72.9 | — | 3 | 3 | — | 6 | 11 |
| Cardiac surgical procedures | D006348 | — | — | — | 1 | 2 | — | 7 | 10 |
| Acute liver failure | D017114 | — | — | — | 2 | 3 | — | 5 | 9 |
| Hepatic insufficiency | D048550 | — | — | — | 2 | 3 | — | 5 | 9 |
| Laparoscopy | D010535 | — | — | — | — | 2 | — | 6 | 8 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | 1 | 2 | — | 5 | 7 |
| Triple negative breast neoplasms | D064726 | — | — | 4 | 3 | 3 | — | — | 7 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 10 | 12 | — | — | 1 | 21 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 2 | — | — | 8 | 11 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 7 | 4 | — | — | 1 | 9 |
| Hematologic neoplasms | D019337 | — | — | 2 | 5 | — | — | 1 | 8 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 8 | — | — | — | 8 |
| B-cell lymphoma | D016393 | — | — | 6 | 2 | — | — | — | 8 |
| Hodgkin disease | D006689 | — | C81 | 4 | 4 | — | — | — | 7 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 2 | — | — | — | 7 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 3 | — | — | 4 | 7 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | 5 | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 13 | — | — | — | 3 | 16 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | 4 | 6 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | 4 | 5 |
| Spondylolisthesis | D013168 | EFO_0007493 | M43.1 | 1 | — | — | — | 4 | 5 |
| Facial pain | D005157 | — | R51.9 | 1 | — | — | — | 3 | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | 2 | 3 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Newborn infant diseases | D007232 | — | — | 1 | — | — | — | 2 | 3 |
| Obstetric labor complications | D007744 | — | — | 1 | — | — | — | 2 | 3 |
| Spondylosis | D055009 | — | M47 | 1 | — | — | — | 2 | 3 |
Show 42 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 6 | 6 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | — | — | 5 | 5 |
| Prolapse | D011391 | — | — | — | — | — | — | 4 | 4 |
| Congenital heart defects | D006330 | — | Q24.9 | — | — | — | — | 4 | 4 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 4 | 4 |
| Plantar fasciitis | D036981 | EFO_1001909 | M72.2 | — | — | — | — | 4 | 4 |
| Fasciitis | D005208 | HP_0100537 | M72.9 | — | — | — | — | 4 | 4 |
| Tick-borne encephalitis | D004675 | EFO_1001309 | A84 | — | — | — | — | 3 | 3 |
| Encephalitis | D004660 | — | — | — | — | — | — | 3 | 3 |
| Shoulder injuries | D000070599 | — | — | — | — | — | — | 3 | 3 |
Show 292 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Acetaminophen |
| INN | paracetamol |
| Description | Paracetamol is a member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. It has a role as a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a non-narcotic analgesic, an antipyretic, a non-steroidal anti-inflammatory drug, a cyclooxygenase 3 inhibitor, a xenobiotic, an environmental contaminant, a human blood serum metabolite, a hepatotoxic agent, a ferroptosis inducer and a geroprotector. It is a member of phenols and a member of acetamides. It is functionally related to a 4-aminophenol. |
| Classification | Small molecule |
| Drug class | Analgesics and antipyretics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)Nc1ccc(O)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 103-90-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL112 |
| ChEBI ID | 46195 |
| PubChem CID | 1983 |
| DrugBank | DB00316 |
| UNII ID | 362O9ITL9D (ChemIDplus, GSRS) |
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Acetaminophen
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Acetaminophen
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Butalbital
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Acetaminophen
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Phenylephrine
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Chlorpheniramine
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Acetaminophen
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Codeine
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Acetaminophen
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Dextromethorphan
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Acetaminophen
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Dextromethorphan
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Doxylamine
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Acetaminophen
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Diphenhydramine
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Acetaminophen
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Phenylephrine
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Diphenhydramine
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Acetaminophen
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Hydrocodone
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Acetaminophen
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Oxycodone
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Acetaminophen
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Pentazocine
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Acetaminophen
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Propoxyphene
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Acetaminophen
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Pseudoephedrine
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Acetaminophen
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Tramadol
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PubMed Central
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Safety
Black-box Warning
Black-box warning for: Acetaminophen and codeine, Acetaminophen and codeine phosphate, Allzital butalbital and acetaminophen, Apadaz, Butalbital and acetaminophen, Direct rx, Fioricet with codeine, Hydrocodone bitartrate and acetaminophen, Hyrdrocodone apap, Lortab, Norco, Ofirmev (acetaminophen), Oxycodone and acetaminophen, Percocet, Tramadol hydrochloride and acetaminophen, Trezix, Tylenol with codeine, Ultracet
Adverse Events
Top Adverse Reactions
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381,841 adverse events reported
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