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Ibu, Pedea(ibuprofen)
Advil, Caldolor, Combogesic, Combunox, Duexis, Ibuprohm, Midol, Motrin, Pedea, Reprexain, Sine-aid, Vicoprofen (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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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, Midol, Motrin (generic drugs available since 1986-07-15, discontinued: Aches-n-pain, Cap-profen, Elixsure, Ibu, Ibu-tab, Ibuprin, Ibuprohm, Medipren, Nuprin, Rufen, Tab-profen)
Combinations
Advil, Combogesic, Duexis, Ibuprohm, Motrin, Sine-aid (generic drugs available since 1986-07-15, discontinued: Combunox, Reprexain, Vicoprofen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Chlorpheniramine maleate
+
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL MULTI-SYMPTOM COLD & FLUGSKN-022113 OTC2017-04-28
1 products, RLD, RS
ADVIL ALLERGY AND CONGESTION RELIEFGSKN-022113 OTC2011-12-21
1 products, RLD, RS
Chlorpheniramine maleate
+
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL ALLERGY SINUSGSKN-021441 OTC2002-12-19
1 products, RLD, RS
CHILDREN'S ADVIL ALLERGY SINUSGSKN-021587 OTC2004-02-24
1 products, RLD, RS
Diphenhydramine citrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021394 OTC2005-12-21
1 products, RLD, RS
Diphenhydramine hydrochloride
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021393 OTC2005-12-21
1 products, RLD, RS
Famotidine
+
Ibuprofen
Tradename
Company
Number
Date
Products
DUEXISHorizon PharmaceuticalN-022519 RX2011-04-23
1 products, RLD, RS
Hydrocodone bitartrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
VICOPROFENAbbVieN-020716 DISCN1997-09-23
1 products, RLD
Hide discontinued
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
ADVILGSKN-018989 OTC1984-05-18
1 products, RLD, RS
JUNIOR STRENGTH ADVILGSKN-020267 OTC1996-12-13
1 products
ADVIL MIGRAINE LIQUI-GELSGSKN-020402 OTC2000-03-16
1 products, RLD, RS
ADVIL LIQUI-GELSGSKN-020402 OTC1995-04-20
1 products, RLD, RS
CHILDREN'S ADVIL-FLAVOREDGSKN-020589 OTC1997-11-07
1 products
CHILDREN'S ADVILGSKN-020589 OTC1996-06-27
1 products
INFANT'S ADVILGSKN-020812 OTC2000-01-12
1 products, RLD, RS
CHILDREN'S ADVILGSKN-020944 OTC1998-12-18
1 products
Show 5 marketed
Show 16 discontinued
Ibuprofen
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
COMBUNOXForest LaboratoriesN-021378 DISCN2004-11-26
1 products, RLD
Hide discontinued
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL CONGESTION RELIEFGSKN-022565 OTC2010-05-27
1 products, RLD, RS
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL COLD AND SINUSGSKN-019771 OTC1989-09-19
1 products, RLD, RS
CHILDREN'S ADVIL COLDGSKN-021373 OTC2002-04-18
1 products
ADVIL COLD AND SINUSGSKN-021374 OTC2002-05-30
1 products, RLD, RS
SINE-AID IBJohnson & JohnsonN-019899 OTC1992-12-31
1 products
CHILDREN'S MOTRIN COLDJohnson & JohnsonN-021128 OTC2000-08-01
1 products, RLD, RS
Ibuprofen sodium
Tradename
Company
Number
Date
Products
ADVILGSKN-201803 OTC2012-06-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
advil dual action with acetaminophenNew Drug Application2023-04-13
caldolorNew Drug Application2021-04-30
duexisNew Drug Application2021-06-08
ibuprofenANDA2023-06-17
midol completeOTC monograph not final2023-04-26
motrin ibANDA2023-05-18
reprexainANDA2009-10-27
vicoprofenNew Drug Application2011-08-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ankylosing spondylitisEFO_0003898D013167M45
bursitisEFO_1000941D002062M71.9
dysmenorrheaHP_0100607D004412N94.6
feverHP_0001945D005334R50.9
goutEFO_0004274D006073M10
inflammationMP_0001845D007249—
juvenile arthritisEFO_0002609D001171M08
menorrhagiaHP_0000132D008595N92.0
osteoarthritisEFO_0002506D010003M15-M19
postoperative pain—D010149G89.18
Show 2 more
Agency Specific
FDA
EMA
Expiration
Code
ACETAMINOPHEN / IBUPROFEN, COMBOGESIC, AFT PHARMS LTD
2026-03-01NP
IBUPROFEN, CALDOLOR, CUMBERLAND PHARMS
2024-11-19M-128
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
Ibuprofen, Caldolor, Cumberland Pharms
90726612032-03-16U-2264
90727102032-03-16U-2266
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, Glaxosmithkline
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, Glaxosmithkline
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
666 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_0003843R52121225271388
Postoperative painD010149G89.184813221258
Healthy volunteers/patients—40——3245
Patent ductus arteriosusD004374HP_0001643Q25.0291091239
FeverD005334HP_0001945R50.92—510320
Low back painD017116HP_0003419M54.5—2410217
Acute painD059787R522257117
OsteoarthritisD010003EFO_0002506M15-M193362—14
AnalgesiaD000698—266—13
Knee osteoarthritisD020370EFO_0004616M1732—3512
Show 86 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13111—46
HivD006678O98.7111—46
NeoplasmsD009369C80—21—25
Local anesthesiaD000772—21—13
Breast neoplasmsD001943EFO_0003869C501—1—13
Hiv infectionsD015658EFO_0000764B20—11—13
Altitude sicknessD000532EFO_1000782T70.291—1—13
Impacted toothD014095HP_0011079K01.1—12—13
Sprains and strainsD013180——3——3
PregnancyD011247EFO_0002950Z33.1—11——2
Show 41 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain concussionD001924S06.0—1——23
Unsafe sexD047568—1——23
Cognitive dysfunctionD060825G31.84—1——23
TuberculosisD014376EFO_0000774A15-A19—2———2
PhimosisD010688EFO_1001104N47.111———2
ParaphimosisD010263EFO_1001086N47.211———2
BalanitisD001446EFO_1000833N48.111———2
Retinopathy of prematurityD012178EFO_1001158H35.1—1——12
MalariaD008288EFO_0001068B5412———2
Abdominal herniaD046449K46—1——12
Show 30 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138105————5
Sexually transmitted diseasesD012749A50-A641———34
PharmacokineticsD0105991———12
Drug interactionsD0043471————1
Pure autonomic failureD0549701————1
Orthostatic hypotensionD007024I95.11————1
Hematologic neoplasmsD0193371————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003401————1
Hodgkin diseaseD006689C811————1
Show 11 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9————55
Motor skills disordersD019957F82————44
Cystic fibrosisD003550EFO_0000390E84————33
OrientationD009949————22
Hiv-2D015498————22
Leg ulcerD007871————22
Colonic neoplasmsD003110C18————11
ArthritisD001168EFO_0005856M05-M14————11
Urinary calculiD014545N20.9————11
Pediatric obesityD063766————11
Show 60 more
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)
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
Clinical Variant
No data
Financial
Duexis - Horizon Therapeutics Public
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Caldolor - Cumberland Pharmaceuticals
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 44,802 documents
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Safety
Black-box Warning
Black-box warning for: Caldolor, Duexis
Adverse Events
Top Adverse Reactions
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104,509 adverse events reported
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