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Drug ReportsIbuprofen
Ibu, Pedea(ibuprofen)
/ Ibuprofen, Advil, Caldolor, Combogesic, Combunox, Ibuprofen, Ibuprofen /, Ibuprohm, Midol, Motrin, Pedea, Sine-aid (ibuprofen) is a small molecule pharmaceutical. Ibuprofen was first approved as Ibu on 1982-01-01. It is used to treat ankylosing spondylitis, bursitis, dysmenorrhea, fever, and gout amongst others in the USA. It has been approved in Europe to treat patent ductus arteriosus. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1. In addition, it is known to target peroxisome proliferator-activated receptor gamma, acid-sensing ion channel 1, and sodium-coupled monocarboxylate transporter 1.
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6M
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1Y
2Y
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Advil, Caldolor, Ibuprofen, Midol, Motrin, Neoprofen (discontinued: Aches-n-pain, Advil, Caldolor, Cap-profen, Elixsure, Ibu, Ibu-tab, Ibuprofen, Medipren, Midol, Motrin, Nuprin, Rufen, Tab-profen)
Combinations
Acetaminophen ibuprofen, Advil, Advil dual action with acetaminophen, Combogesic, Hydrocodone ibuprofen, Ibuprofen diphenhydramine, Ibuprofen famotidine, Ibuprofen phenylephrine, Ibuprofen pseudoephedrine, Motrin, Reprexain, Sine-aid (discontinued: Acetaminophen ibuprofen, Combunox, Duexis, Hydrocodone, Hydrocodone ibuprofen, Ibuprofen famotidine, Ibuprofen pseudoephedrine, Oxycodone ibuprofen, Reprexain, Vicoprofen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL COLD AND SINUSGSKN-021374 OTC2002-05-30
1 products, RLD, RS
CHILDREN'S ADVIL COLDGSKN-021373 OTC2002-04-18
1 products
ADVIL COLD AND SINUSGSKN-019771 OTC1989-09-19
1 products, RLD, RS
CHILDREN'S MOTRIN COLDJohnson & JohnsonN-021128 OTC2000-08-01
1 products, RLD, RS
SINE-AID IBJohnson & JohnsonN-019899 OTC1992-12-31
1 products
Ibuprofen
Tradename
Company
Number
Date
Products
MIDOL LIQUID GELSBionPharmaN-021472 OTC2002-10-18
1 products, RLD, RS
CALDOLORCumberland PharmaceuticalsN-022348 RX2009-06-11
2 products, RLD, RS
ADVIL LIQUI-GELSGSKN-020402 OTC1995-04-20
1 products, RLD, RS
ADVIL MIGRAINE LIQUI-GELSGSKN-020402 OTC2000-03-16
1 products, RLD, RS
INFANT'S ADVILGSKN-020812 OTC2000-01-12
1 products, RLD, RS
CHILDREN'S ADVILGSKN-020589 OTC1996-06-27
1 products
CHILDREN'S ADVIL-FLAVOREDGSKN-020589 OTC1997-11-07
1 products
CHILDREN'S ADVILGSKN-020944 OTC1998-12-18
1 products
JUNIOR STRENGTH ADVILGSKN-020944 OTC1998-12-18
1 products
ADVILGSKN-018989 OTC1984-05-18
1 products, RLD, RS
Show 5 marketed
Show 16 discontinued
Diphenhydramine hydrochloride
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021393 OTC2005-12-21
1 products, RLD, RS
Acetaminophen
+
Ibuprofen sodium
Tradename
Company
Number
Date
Products
COMBOGESIC IVHikma PharmaceuticalsN-215320 RX2023-10-17
1 products, RLD, RS
Chlorpheniramine maleate
+
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
CHILDREN'S ADVIL ALLERGY SINUSGSKN-021587 OTC2004-02-24
1 products, RLD, RS
ADVIL ALLERGY SINUSGSKN-021441 OTC2002-12-19
1 products, RLD, RS
Ibuprofen sodium
Tradename
Company
Number
Date
Products
ADVILGSKN-201803 OTC2012-06-12
1 products, RLD, RS
Chlorpheniramine maleate
+
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL ALLERGY AND CONGESTION RELIEFGSKN-022113 OTC2011-12-21
1 products, RLD, RS
ADVIL MULTI-SYMPTOM COLD & FLUGSKN-022113 OTC2017-04-28
1 products, RLD, RS
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL CONGESTION RELIEFGSKN-022565 OTC2010-05-27
1 products, RLD, RS
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
Diphenhydramine citrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021394 OTC2005-12-21
1 products, RLD, RS
Ibuprofen
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
COMBUNOXForest LaboratoriesN-021378 DISCN2004-11-26
1 products, RLD
Hide discontinued
Famotidine
+
Ibuprofen
Tradename
Company
Number
Date
Products
DUEXISHorizon Therapeutics PublicN-022519 DISCN2011-04-23
1 products, RLD
Hide discontinued
Hydrocodone bitartrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
VICOPROFENAbbVieN-020716 DISCN1997-09-23
1 products, RLD
Hide discontinued
Ibuprofen lysine
Tradename
Company
Number
Date
Products
NEOPROFENRecordatiN-021903 RX2006-04-13
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
10 person ansiOTC monograph final2010-06-07
24/7 life ibuprofenANDA2024-12-30
25 person ansiOTC monograph final2010-06-07
365 everday value ibuprofenANDA2023-07-27
365 whole foods market ibuprofenANDA2024-11-26
50 person ansiOTC monograph final2010-06-07
acetaminophen 250 mg and ibuprofen 125 mgANDA2025-04-04
acetaminophen and ibuprofenANDA2025-07-17
acetaminophen and ibuprofen (nsaid)ANDA2024-12-23
acetaminophen and ibuprofen back painANDA2025-04-09
Show 297 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
juvenile arthritisEFO_1002007D001171M08
menorrhagiaEFO_0003945D008595N92.0
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
fever—D005334R50.9
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
postoperative pain—D010149G89.18
sinusitisEFO_0007486D012852J32
asthmaEFO_0000270D001249J45
Show 31 more
Agency Specific
FDA
EMA
Expiration
Code
ACETAMINOPHEN / IBUPROFEN SODIUM, COMBOGESIC IV, HIKMA
2026-10-17NP
IBUPROFEN, CALDOLOR, CUMBERLAND PHARMS
2026-05-11NPP
2024-11-19M-128
ACETAMINOPHEN / IBUPROFEN, COMBOGESIC, AFT PHARMS LTD
2026-03-01NP
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 / Ibuprofen Sodium, Combogesic Iv, Hikma
112134982036-01-14DP
113894162035-07-17DP
114462662031-10-26U-3744, U-3745
Ibuprofen, Caldolor, Cumberland Pharms
90726612032-03-16U-2264
90727102032-03-16U-2266
118064002032-03-16U-3746
90125082030-09-14U-981
87354522029-09-30U-981
88718102029-09-30U-981
91140682029-09-30U-1735
91384042029-09-30U-1756
92956392029-09-30U-1756
96492842029-09-30U-2018
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Advil Allergy Sinus, Haleon Us Holdings
78632872027-02-28DP
Famotidine / Ibuprofen, Duexis, Horizon
80674512026-07-18DPU-1196
83091272026-07-18DP
83182022026-07-18DP
84499102026-07-18DP
85012282026-07-18U-1196
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Children'S Advil Allergy Sinus, Haleon Us Holdings
102386402024-05-25DP
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01E: Other cardiac preparations in atc
— C01EB: Other plain cardiac preparations in atc
— C01EB16: Ibuprofen
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CC: Antiinflammatory products for vaginal administration
— G02CC01: Ibuprofen
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE01: Ibuprofen
— M01AE51: Ibuprofen, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA13: Ibuprofen
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ08: Codeine and ibuprofen
— N02AJ19: Oxycodone and ibuprofen
R: Respiratory system drugs
— R02: Throat preparations
— R02A: Throat preparations
— R02AX: Other throat preparations in atc
— R02AX02: Ibuprofen
HCPCS
Code
Description
J1741
Injection, ibuprofen, 100 mg
Clinical
Clinical Trials
1186 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIbuprofen
INNibuprofen
Description
Ibuprofen is a monocarboxylic acid that is propionic acid in which one of the hydrogens at position 2 is substituted by a 4-(2-methylpropyl)phenyl group. It has a role as a non-steroidal anti-inflammatory drug, a non-narcotic analgesic, a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, an antipyretic, a xenobiotic, an environmental contaminant, a radical scavenger, a drug allergen and a geroprotector. It is functionally related to a propionic acid. It is a conjugate acid of an ibuprofen(1-).
Classification
Small molecule
Drug classanti-inflammatory/analgesic agents (ibuprofen type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)Cc1ccc(C(C)C(=O)O)cc1
Identifiers
PDB—
CAS-ID15687-27-1
RxCUI—
ChEMBL IDCHEMBL521
ChEBI ID5855
PubChem CID3672
DrugBankDB01050
UNII IDWK2XYI10QM (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
PPARG
PPARG
ASIC1
ASIC1
SLC5A8
SLC5A8
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
5468
Protein name
peroxisome proliferator-activated receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group C member 3, peroxisome proliferator-activated receptor-gamma 5, peroxisome proliferator-activated receptor-gamma splicing, PPAR-gamma
Uniprot ID
Q96J12
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Duexis – Horizon Therapeutics Public
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Caldolor – Cumberland Pharmaceuticals
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Estimated US medical usage
Ibuprofen
+
Famotidine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Ibuprofen
+
Hydrocodone
Total medical expenditures per year (USD, in millions)
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Ibuprofen
Total medical expenditures per year (USD, in millions)
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Ibuprofen
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Oxycodone
Total medical expenditures per year (USD, in millions)
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Ibuprofen
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Pseudoephedrine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 69,016 documents
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Safety
Black-box Warning
Black-box warning for: Alivio, Caldolor, Combogesic, Combogesic iv, Corvert, Counteract, Hydrocodone bitartrate and ibuprofen, Ibu, Ibupak, Ibuprofen, Ibuprofen and famotidine, Ibuprofen famotidine, Ibuprofentablets, Prastera, Prastera - ibuprofen, Theraprofen-60, Theraprofen-800, Toxicology saliva collection kit
Adverse Events
Top Adverse Reactions
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162,214 adverse events reported
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