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Drug ReportsAcetaminophen
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
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Acetaminophen, Feverall, Tylenol (discontinued: Acephen, Acetaminophen, Feverall, Injectapap, Neopap, Ofirmev, Tylenol)
Combinations
Acetaminophen codeine, Acetaminophen ibuprofen, Acetaminophen, aspirin caffeine, Advil dual action with acetaminophen, Anexsia, Butalbital acetaminophen, Butalbital, acetaminophen caffeine, Butalbital, acetaminophen, caffeine codeine, Combogesic, Excedrin (migraine relief), Fioricet, Hydrocodone acetaminophen, Oxycet, Oxycodone acetaminophen, Percocet, Tramadol acetaminophen (discontinued: Acetaminophen codeine, Acetaminophen hydrocodone, 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
ACETAMINOPHENB. Braun MedicalN-204957 RX2021-02-18
2 products, RLD, RS
ACETAMINOPHENFresenius KabiN-204767 RX2015-10-28
1 products
ACETAMINOPHENHikma PharmaceuticalsN-206968 RX2022-06-03
1 products, RLD, RS
TYLENOLJohnson & JohnsonN-019872 OTC1994-06-08
2 products, RLD, RS
ACETAMINOPHENTaro PharmaceuticalN-018337 OTC1982-01-01
2 products, RLD
INFANTS' FEVERALLTaro PharmaceuticalN-018337 OTC1992-08-26
1 products, RLD
Show 7 discontinued
Acetaminophen
+
Tramadol hydrochloride
Tradename
Company
Number
Date
Products
ULTRACETJohnson & JohnsonN-021123 DISCN2001-08-15
1 products, RLD
Hide discontinued
Acetaminophen
+
Ibuprofen
Tradename
Company
Number
Date
Products
COMBOGESICAFT PHARMS USN-209471 RX2023-03-01
1 products, RLD, RS
ADVIL DUAL ACTION WITH ACETAMINOPHENGSKN-211733 OTC2020-02-28
1 products, RLD, RS
Acetaminophen
+
Clemastine fumarate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
TAVIST ALLERGY/SINUS/HEADACHENovartisN-021082 DISCN2001-03-01
1 products
Hide discontinued
Acetaminophen
+
Pentazocine hydrochloride
Tradename
Company
Number
Date
Products
TALACENSanofiN-018458 DISCN1982-09-23
1 products
Hide discontinued
Acetaminophen
+
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DRIXORAL PLUSMerck & CoN-019453 DISCN1987-05-22
1 products
Hide discontinued
Acetaminophen
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
XARTEMIS XRMallinckrodtN-204031 DISCN2014-03-11
1 products, RLD
Hide discontinued
Acetaminophen
+
Propoxyphene napsylate
Tradename
Company
Number
Date
Products
DARVOCET-N 50Xanodyne PharmaceuticalsN-017122 DISCN1982-01-01
1 products
DARVOCET-N 100Xanodyne PharmaceuticalsN-017122 DISCN1982-01-01
1 products
Hide discontinued
Acetaminophen
+
Propoxyphene hydrochloride
Tradename
Company
Number
Date
Products
DARVOCETAAIPharmaN-016844 DISCN1982-01-01
1 products
Hide discontinued
Acetaminophen
+
Aspirin
+
Caffeine
Tradename
Company
Number
Date
Products
EXCEDRIN (MIGRAINE RELIEF)GSKN-020802 OTC1998-01-14
1 products, RLD, RS
Acetaminophen
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORICET W/ CODEINEAllerganN-020232 RX1992-07-30
1 products, RLD, RS
Acetaminophen
+
Benzhydrocodone hydrochloride
Tradename
Company
Number
Date
Products
APADAZZevra TherapeuticsN-208653 DISCN2018-02-23
3 products, RLD
Hide discontinued
Acetaminophen
+
Ibuprofen sodium
Tradename
Company
Number
Date
Products
COMBOGESIC IVHikma PharmaceuticalsN-215320 RX2023-10-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
8 hour pain reliefANDA2024-07-24
ac fastOTC monograph not final2021-04-02
acephenANDA2016-03-09
acetaminophenC2002632024-07-30
acetaminophen - apap 8 hourANDA2024-12-27
acetaminophen - apap arthritisANDA2024-12-27
acetaminophen 500 mgC2002632024-07-16
acetaminophen and codeineANDA2024-07-25
acetaminophen and codeine phosphateANDA2024-07-31
acetaminophen-apap 8 hourANDA2013-01-17
Show 105 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
fever—D005334R50.9
cough—D003371R05
postoperative pain—D010149G89.18
obstructive lung diseases—D008173—
headache—D006261R51
fatigue—D005221R53.83
apnea—D001049R06.81
rheumatoid arthritisEFO_0000685D001172M06.9
inflammationMP_0001845D007249—
Show 15 more
Agency Specific
FDA
EMA
Expiration
Code
ACETAMINOPHEN / IBUPROFEN, COMBOGESIC, AFT PHARMS LTD
2026-03-01NP
ACETAMINOPHEN / IBUPROFEN, ADVIL DUAL ACTION WITH ACETAMINOPHEN, GLAXOSMITHKLINE
2023-02-28NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Acetaminophen / Ibuprofen, Combogesic, Aft Pharms Ltd
111978302039-02-27DPU-3553
115344072039-02-27DPU-3553
105320362025-09-22U-3553
Acetaminophen / Oxycodone Hydrochloride, Xartemis Xr, Mallinckrodt Inc
86586312032-05-16DP
87418852032-05-16DPU-1499
89929752032-05-16DP
90503352032-05-16DP
94686362032-05-16U-1499
85976812030-12-21DP
89803192030-12-21DP
83774532029-11-19DPU-1499
83724322029-03-11DPU-1499
83944082029-03-11DP
86689292029-03-11U-1499
79768702027-06-01U-1498
Acetaminophen, Ofirmev, Mallinckrodt Hosp
93990122031-09-11U-2261, U-2262
96102652028-11-13U-2263
99872382028-11-13U-2261
103838342028-11-13U-2262, U-2621
Acetaminophen / Benzhydrocodone Hydrochloride, Apadaz, Zevra Therap
84611372031-02-22DS, DP
87484132030-07-10DS, DP
88289782030-07-01DP
91321252030-07-01DS, DPU-2249
95499232030-07-01DS, DP
Acetaminophen, Acetaminophen, Fresenius Kabi Usa
87419592030-04-19DP
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
2433 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R523—2117
Common coldD003139EFO_0007214J001113—6
OsteoarthritisD010003EFO_0002506M15-M191—1114
ToothacheD014098—K08.89—1—2—3
Streptococcal infectionsD013290EFO_1001476———11—2
Postoperative painD010149—G89.18———2—2
Human influenzaD007251EFO_0007328J11.1———1—1
Knee osteoarthritisD020370EFO_0004616M17———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HeadacheD006261—R51212——4
Respiratory tract infectionsD012141—J06.9——2——2
InfectionsD007239EFO_0000544———2——2
Tension-type headacheD018781—G44.2111——2
PemphigusD010392EFO_1000749L10——1——1
Migraine disordersD008881EFO_0003821G43——1——1
Rotavirus infectionsD012400————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Critical illnessD016638———1———1
GastroparesisD018589EFO_1000948K31.84—1———1
LymphomaD008223—C85.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Headache disordersD020773EFO_0009550G441————1
FeverD005334—R50.91————1
AnalgesiaD000698——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAcetaminophen
INNparacetamol
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 classAnalgesics and antipyretics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)Nc1ccc(O)cc1
Identifiers
PDB—
CAS-ID103-90-2
RxCUI—
ChEMBL IDCHEMBL112
ChEBI ID46195
PubChem CID1983
DrugBankDB00316
UNII ID362O9ITL9D (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Estimated US medical usage
Acetaminophen
Total medical expenditures per year (USD, in millions)
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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
+
Diphenhydramine
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Acetaminophen
+
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
Total medical expenditures per year (USD, in millions)
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Acetaminophen
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Pseudoephedrine
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Acetaminophen
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Tramadol
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,695 documents
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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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367,406 adverse events reported
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