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Acetaminophen
Acephen, Allay, Anexsia, Anoquan, Apadaz, Bancap, Bucet, Butapap, Co-gesic, Codrix, Combogesic, Darvocet, Dhc, Dolene Ap, Drixoral, Empracet, Esgic, Excedrin (migraine Relief), Femcet, Feverall, Fioricet, Hy-phen, Lorcet-hd, Lortab, Medigesic, Norcet, Norco, Papeine, Percocet, Phenaphen, Phrenilin, Propacet, Proval, Roxicet, Roxilox, Sedapap, Synalgos-dc-a, Talacen, Tavist, Tencon, Triad, Triaprin, Tycolet, Tylenol, Tylox, Ultracet, Vicodin, Wygesic, Xartemis, Zydone, Zyfrel (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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Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Acephen, Feverall, Tylenol (generic drugs available since 1982-01-01, discontinued: Injectapap, Neopap, Ofirmev)
Combinations
Combogesic, Excedrin (migraine relief), Fioricet (generic drugs available since 1982-01-01, discontinued: Allay, Anexsia, Anoquan, Apadaz, Bancap, Bucet, Butapap, Co-gesic, Codrix, Darvocet, Darvocet a500, Darvocet-n, Dhc, Dolene ap, Drixoral, Duradyne dhc, Empracet, Esgic, Femcet, Hy-phen, Lorcet-hd, Lortab, Medigesic, Norcet, Norco, Papeine, Percocet, Phenaphen, Phrenilin, Propacet, Proval, Roxicet, Roxilox, Sedapap, Synalgos-dc-a, Talacen, Tavist, Tencon, Triad, Triaprin, Tycolet, Tylenol, Tylox, Ultracet, Vicodin, Wygesic, Xartemis, Zydone, Zyfrel)
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
ACEPHENCosette Pharmaceuticals N-018060 OTC1982-01-01
1 products
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
INFANTS' FEVERALLTaro PharmaceuticalN-018337 OTC1992-08-26
1 products, RLD
ACETAMINOPHENTaro PharmaceuticalN-018337 OTC1982-01-01
3 products, RLD
Show 6 discontinued
Acetaminophen
+
Aspirin
+
Caffeine
Tradename
Company
Number
Date
Products
EXCEDRIN (MIGRAINE RELIEF)GSKN-020802 OTC1998-01-14
1 products, RLD, RS
Acetaminophen
+
Benzhydrocodone hydrochloride
Tradename
Company
Number
Date
Products
APADAZKVK TechN-208653 DISCN2018-02-23
3 products, RLD
Hide discontinued
Acetaminophen
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORICET W/ CODEINEAllerganN-020232 RX1992-07-30
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
+
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DRIXORAL PLUSMerck Sharp & DohmeN-019453 DISCN1987-05-22
1 products
Hide discontinued
Acetaminophen
+
Ibuprofen
Tradename
Company
Number
Date
Products
COMBOGESICAFT PharmaceuticalsN-209471 RX2023-03-01
1 products, RLD, RS
ADVIL DUAL ACTION WITH ACETAMINOPHENGSKN-211733 OTC2020-02-28
1 products, RLD, RS
Acetaminophen
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
XARTEMIS XRMallinckrodtN-204031 DISCN2014-03-11
1 products, RLD
Hide discontinued
Acetaminophen
+
Pentazocine hydrochloride
Tradename
Company
Number
Date
Products
TALACENSanofiN-018458 DISCN1982-09-23
1 products
Hide discontinued
Acetaminophen
+
Propoxyphene hydrochloride
Tradename
Company
Number
Date
Products
DARVOCETAAIPharmaN-016844 DISCN1982-01-01
1 products
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
+
Tramadol hydrochloride
Tradename
Company
Number
Date
Products
ULTRACETJohnson & JohnsonN-021123 DISCN2001-08-15
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acephen ANDA2016-03-09
allzital butalbital and acetaminophenANDA2021-10-18
apadazNew Drug Application2021-03-12
codrix2008-05-16
esgicANDA2022-11-09
extra strength pain reliefOTC monograph not final2023-06-21
extra strength tylenol severe cough plus sore throat nightOTC monograph final2023-04-07
feverallOTC monograph not final2023-06-09
fioricetANDA2021-01-01
lortabANDA2021-08-24
Show 8 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
feverHP_0001945D005334R50.9
painEFO_0003843D010146R52
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, Kvk Tech Inc
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
1112 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149G89.18718417334171
PainD010146EFO_0003843R521324285326139
Healthy volunteers/patients—33—15746
Acute painD059787R52421014434
FeverD005334HP_0001945R50.9351012533
AnalgesiaD00069833810629
Patent ductus arteriosusD004374HP_0001643Q25.021073624
Low back painD017116HP_0003419M54.51278422
OsteoarthritisD010003EFO_0002506M15-M192258320
Knee osteoarthritisD020370EFO_0004616M172242817
Show 169 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0241——7
Dental pinsD003772—51——6
Lupus nephritisD008181EFO_0005761—23——5
Covid-19D000086382U07.1—23——4
Head and neck neoplasmsD006258111—14
Systemic lupus erythematosusD008180EFO_0002690M32—14——4
VomitingD014839HP_0002013R11.1——4——4
PregnancyD011247EFO_0002950Z33.1——1—23
Respiratory insufficiencyD012131HP_0002093J96.9—11—13
Hiv infectionsD015658EFO_0000764B20——1—23
Show 62 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PulpitisD011671EFO_1001139K04.0—3——36
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.032———4
Non-hodgkin lymphomaD008228C85.923———4
Cleft palateD002972Q35—2——13
Male breast neoplasmsD018567—1——23
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034031———3
Type 1 diabetes mellitusD003922EFO_0001359E10—1——23
AnxietyD001007EFO_0005230F41.1—1——23
Alzheimer diseaseD000544EFO_0000249F03—2——13
PhimosisD010688EFO_1001104N47.111———2
Show 60 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD0105991———23
Therapeutic equivalencyD0138103————3
OverweightD050177E66.32———13
Ankle fracturesD064386S82.51———12
Intervertebral disc degenerationD055959HP_00084191———12
Magnetic resonance imagingD0082791————1
Oral administrationD0002841————1
Hematologic neoplasmsD0193371————1
Systemic mastocytosisD034721C96.211————1
Hairy cell leukemiaD007943C91.41————1
Show 18 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vitreoretinal surgeryD057586————33
Congenital heart defectsD006330HP_0001627Q24.9————33
ThyroidectomyD013965————22
Retinopathy of prematurityD012178EFO_1001158H35.1————22
Intervertebral disc displacementD007405EFO_1001800————22
Female genital diseasesD005831EFO_0009549N85————22
Aspirin-induced asthmaD055963HP_0012042————11
AnaphylaxisD000707T78.2————11
HemostasisD006487————11
Aortic valve diseaseD000082862————11
Show 64 more
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)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)Nc1ccc(O)cc1
Identifiers
PDB3PY4
CAS-ID103-90-2
RxCUI161
ChEMBL IDCHEMBL112
ChEBI ID46195
PubChem CID1983
DrugBankDB00316
UNII ID362O9ITL9D (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PTGS2
PTGS2
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
5743
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Q16876
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 102,143 documents
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Safety
Black-box Warning
Black-box warning for: Allzital butalbital and acetaminophen, Apadaz, Fioricet, Lortab, Norco, Ofirmev (acetaminophen), Percocet, Trezix, Ultracet
Adverse Events
Top Adverse Reactions
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1,623 adverse events reported
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