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ibuprofen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibuprofen derivatives	1407	15687-27-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ibuprofen lysine ibuprofen lysinate ibuprofen lysine salt soluphene solufenum neoprofen ibuprofen ibuprofen sodium	A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS. Concerns that anti-inflammatory drugs such as ibuprofen may worsen COVID-19 circulated widely in the early months of the pandemic. FDA has stated that it is not aware of scientific evidence connecting the use of NSAIAs, such as ibuprofen, with worsening COVID-19 symptoms and will communicate publicly when more information is available. Molecular weight: 206.29 Formula: C13H18O2 CLOGP: 3.68 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 37.30 ALOGS: -3.48 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ibuprofen lysine
ibuprofen lysinate
ibuprofen lysine salt
soluphene
solufenum
neoprofen
ibuprofen
ibuprofen sodium

A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS. Concerns that anti-inflammatory drugs such as ibuprofen may worsen COVID-19 circulated widely in the early months of the pandemic. FDA has stated that it is not aware of scientific evidence connecting the use of NSAIAs, such as ibuprofen, with worsening COVID-19 symptoms and will communicate publicly when more information is available.

Molecular weight: 206.29
Formula: C13H18O2
CLOGP: 3.68
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 37.30
ALOGS: -3.48
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	P
1.20	g	O
1.20	g	P
1.20	g	R

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	85 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	193.90 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	1.60 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.82 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.15 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.04 mg/mL	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Jan. 19, 2018	PMDA	Senju Pharmaceutical Co., Ltd.
Sept. 19, 1974	FDA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intentional overdose	1007.13	9.88	1690	380867	72462	63034003
Muscle injury	615.54	9.88	1273	381284	64072	63042393
Irritable bowel syndrome	588.72	9.88	1438	381119	80974	63025491
Folliculitis	583.25	9.88	1301	381256	69016	63037449
Cholecystitis chronic	509.38	9.88	454	382103	9907	63096558
Injury	498.75	9.88	1255	381302	71992	63034473
Angioedema	483.24	9.88	961	381596	47004	63059461
Lower respiratory tract infection	463.66	9.88	1799	380758	130508	62975957
Blister	458.90	9.88	1770	380787	128044	62978421
Sleep disorder due to general medical condition, insomnia type	430.55	9.88	964	381593	51253	63055212

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Angioedema	557.89	10.22	759	155538	36615	34764019
Intentional overdose	506.34	10.22	787	155510	42887	34757747
Suicide attempt	360.67	10.22	636	155661	38480	34762154
Haematemesis	333.17	10.22	508	155789	27203	34773431
Drug hypersensitivity	309.80	10.22	926	155371	79603	34721031
Melaena	301.58	10.22	556	155741	34824	34765810
Death	263.80	10.22	907	155390	397142	34403492
Urticaria	263.64	10.22	742	155555	61635	34738999
Aspirin-exacerbated respiratory disease	251.67	10.22	86	156211	301	34800333
Febrile neutropenia	250.27	10.22	151	156146	136698	34663936

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intentional overdose	1394.36	9.86	2267	437410	103693	79201018
Angioedema	1074.51	9.86	1681	437996	74354	79230357
Suicide attempt	632.72	9.86	1407	438270	81525	79223186
Off label use	597.11	9.86	2776	436901	904439	78400272
Drug hypersensitivity	566.16	9.86	3188	436489	295728	79008983
Urticaria	520.61	9.86	2212	437465	182989	79121722
Injury	500.65	9.86	1232	438445	76264	79228447
Cholecystitis chronic	453.19	9.86	401	439276	9505	79295206
Febrile neutropenia	452.17	9.86	366	439311	230633	79074078
Death	448.49	9.86	1611	438066	564903	78739808

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intestinal perforation	53.58	22.06	22	728	67	88975
Oliguria	33.35	22.06	10	740	6	89036
Intraventricular haemorrhage	30.75	22.06	18	732	138	88904
Product use in unapproved indication	28.21	22.06	10	740	17	89025
Pulmonary arterial hypertension	26.55	22.06	10	740	22	89020
Posthaemorrhagic hydrocephalus	23.38	22.06	13	737	89	88953
Product use issue	22.62	22.06	16	734	175	88867
Nasal congestion	22.44	22.06	9	741	25	89017
Incorrect route of product administration	22.30	22.06	7	743	6	89036

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Pharmacologic Action:

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Source	Code	Description
ATC	C01EB16	CARDIOVASCULAR SYSTEM CARDIAC THERAPY OTHER CARDIAC PREPARATIONS Other cardiac preparations
ATC	G02CC01	GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS OTHER GYNECOLOGICALS Antiinflammatory products for vaginal administration
ATC	M01AE01	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Propionic acid derivatives
ATC	M01AE51	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Propionic acid derivatives
ATC	M02AA13	MUSCULO-SKELETAL SYSTEM TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN Antiinflammatory preparations, non-steroids for topical use
ATC	N02AJ08	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ19	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	R02AX02	RESPIRATORY SYSTEM THROAT PREPARATIONS THROAT PREPARATIONS Other throat preparations
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35493	anti-pyretic

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Sinus headache	indication	4969004
Pain	indication	22253000
Rheumatoid arthritis	indication	69896004	DOID:7148
Severe pain	indication	76948002
Patent ductus arteriosus	indication	83330001	DOID:13832
Headache disorder	indication	230461009
Dysmenorrhea	indication	266599000
Influenza-like symptoms	indication	315642008
Fever	indication	386661006
Osteoarthritis	indication	396275006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.37	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
26.6MG;800MG	DUEXIS	HORIZON	N022519	April 23, 2011	RX	TABLET	ORAL	8067451	July 18, 2026	RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
26.6MG;800MG	DUEXIS	HORIZON	N022519	April 23, 2011	RX	TABLET	ORAL	8501228	July 18, 2026	RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
325MG;97.5MG	COMBOGESIC	AFT PHARMS LTD	N209471	March 1, 2023	RX	TABLET	ORAL	10532036	Sept. 22, 2025	A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;97.5MG	COMBOGESIC	AFT PHARMS LTD	N209471	March 1, 2023	RX	TABLET	ORAL	11197830	Feb. 27, 2039	A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;97.5MG	COMBOGESIC	AFT PHARMS LTD	N209471	March 1, 2023	RX	TABLET	ORAL	11534407	Feb. 27, 2039	A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	8735452	Sept. 30, 2029	MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	8871810	Sept. 30, 2029	MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	9012508	Sept. 14, 2030	MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	9072661	March 16, 2032	METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	9072710	March 16, 2032	METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
250MG;125MG	ADVIL DUAL ACTION WITH ACETAMINOPHEN	GLAXOSMITHKLINE	N211733	Feb. 28, 2020	OTC	TABLET	ORAL	Feb. 28, 2023	NEW PRODUCT
325MG;97.5MG	COMBOGESIC	AFT PHARMS LTD	N209471	March 1, 2023	RX	TABLET	ORAL	March 1, 2026	NEW PRODUCT
400MG/4ML (100MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	June 11, 2009	DISCN	SOLUTION	INTRAVENOUS	Nov. 19, 2024	CLINICAL TRIAL STUDY RESULTS
800MG/200ML (4MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	Jan. 25, 2019	RX	SOLUTION	INTRAVENOUS	Nov. 19, 2024	CLINICAL TRIAL STUDY RESULTS
800MG/8ML (100MG/ML)	CALDOLOR	CUMBERLAND PHARMS	N022348	June 11, 2009	RX	SOLUTION	INTRAVENOUS	Nov. 19, 2024	CLINICAL TRIAL STUDY RESULTS

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	5.14	WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	5.12	WOMBAT-PK	CHEMBL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		Ki	4.30	WOMBAT-PK
Aldo-keto reductase family 1 member C2	Enzyme	P52895	AK1C2_HUMAN		IC50	4.37	CHEMBL
Aldo-keto reductase family 1 member C3	Enzyme	P42330	AK1C3_HUMAN		IC50	4.48	CHEMBL
Arachidonate 5-lipoxygenase	Enzyme	P09917	LOX5_HUMAN				WOMBAT-PK
Serum albumin	Secreted	P02768	ALBU_HUMAN		Kd	4.14	CHEMBL
Interleukin-8	Cytokine	P10145	IL8_HUMAN		IC50	7.30	CHEMBL
Sodium-coupled monocarboxylate transporter 1	Transporter	Q8N695	SC5A8_HUMAN	INHIBITOR	IC50	4.20	IUPHAR
Acid-sensing ion channel 1	Ion channel	P78348	ASIC1_HUMAN	BLOCKER	IC50	3.53	SCIENTIFIC LITERATURE

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External reference:

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ID	Source
IBP	PDB_CHEM_ID
002377	NDDF
006088	NDDF
006232	NDDF
1429044	RXNORM
2118	INN_ID
2133	MMSL
240518	MMSL
2713	IUPHAR_LIGAND_ID
32273	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
basic care childrens ibuprofen	HUMAN OTC DRUG LABEL	1	0113-1461	TABLET, CHEWABLE	100 mg	ORAL	ANDA	15 sections
basic care childrens ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7660	SUSPENSION	100 mg	ORAL	ANDA	15 sections
Basic Care childrens ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7897	SUSPENSION	100 mg	ORAL	ANDA	15 sections
basic care ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7131	CAPSULE, LIQUID FILLED	200 mg	ORAL	ANDA	16 sections
basic care ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7517	TABLET, FILM COATED	200 mg	ORAL	ANDA	16 sections
basic care ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7517	TABLET, FILM COATED	200 mg	ORAL	ANDA	16 sections
Basic Care Ibuprofen	HUMAN OTC DRUG LABEL	1	0113-7604	TABLET, FILM COATED	200 mg	ORAL	ANDA	16 sections
Good Sense Childrens Ibuprofen	HUMAN OTC DRUG LABEL	1	0113-2461	TABLET, CHEWABLE	100 mg	ORAL	ANDA	15 sections
good sense dual action	HUMAN OTC DRUG LABEL	2	0113-5300	TABLET, FILM COATED	125 mg	ORAL	ANDA	16 sections
Good Sense ibuprofen	HUMAN OTC DRUG LABEL	1	0113-0074	TABLET, FILM COATED	200 mg	ORAL	ANDA	16 sections

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