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

Stem definition	Drug id	CAS RN
human origin	4904	331731-18-1

Description:

Molecule	Description
Synonyms: yuflym ADALIMUMAB-ADBM adalimumab-atto amjevita adalimumab humira adalimumab (genetical recombination) LU200134 D2E7	A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

yuflym
ADALIMUMAB-ADBM
adalimumab-atto
amjevita
adalimumab
humira
adalimumab (genetical recombination)
LU200134
D2E7

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
2.90	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
April 16, 2008	PMDA	AbbVie GK
Dec. 31, 2002	FDA	ABBVIE INC
Sept. 8, 2003	EMA	AbbVie Deutschland GmbH Co. KG

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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
Drug ineffective	9908.40	11.59	27298	596376	1017467	61847881
Therapy interrupted	3756.33	11.59	2868	620806	29587	62835761
Drug intolerance	3281.87	11.59	8465	615209	300196	62565152
Contraindicated product administered	2521.26	11.59	6171	617503	211477	62653871
Therapeutic product effect decreased	2420.99	11.59	5648	618026	187539	62677809
Treatment failure	2335.17	11.59	5672	618002	193371	62671977
Synovitis	2288.87	11.59	5416	618258	181502	62683846
Joint swelling	2137.88	11.59	7570	616104	320096	62545252
Arthropathy	1705.99	11.59	5626	618048	229166	62636182
Systemic lupus erythematosus	1648.26	11.59	5150	618524	203768	62661580

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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
Drug ineffective	4145.06	11.64	8270	185267	448481	34314913
Therapy interrupted	1308.28	11.64	861	192676	12836	34750558
Joint swelling	1199.06	11.64	1565	191972	58325	34705069
Therapeutic product effect decreased	1186.38	11.64	1197	192340	33546	34729848
Arthralgia	1040.53	11.64	2649	190888	167392	34596002
Psoriasis	996.20	11.64	1150	192387	37662	34725732
Drug interaction	960.06	11.64	78	193459	225868	34537526
Acute kidney injury	824.61	11.64	330	193207	304658	34458736
Toxicity to various agents	806.10	11.64	86	193451	200276	34563118
Injection site pain	742.58	11.64	995	192542	38010	34725384

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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
Drug ineffective	7643.13	10.90	20332	531047	1060581	78132428
Therapy interrupted	5819.15	10.90	3266	548113	28075	79164934
Drug intolerance	3288.65	10.90	6254	545125	257865	78935144
Synovitis	2962.14	10.90	4381	546998	146353	79046656
Joint swelling	2922.26	10.90	6272	545107	282374	78910635
Therapeutic product effect decreased	2682.42	10.90	4378	547001	159485	79033524
Treatment failure	2438.10	10.90	4289	547090	166197	79026812
Contraindicated product administered	2398.79	10.90	4075	547304	153463	79039546
Toxicity to various agents	1978.00	10.90	283	551096	421257	78771752
Drug interaction	1956.82	10.90	275	551104	414908	78778101

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AB04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA CS	M0001357	Antibodies, Monoclonal
FDA EPC	N0000175610	Tumor Necrosis Factor Blocker
FDA MoA	N0000175451	Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D000079424	Tumor Necrosis Factor Inhibitors

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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
Ankylosing spondylitis	indication	9631008	DOID:7147
Psoriasis with arthropathy	indication	33339001
Crohn's disease	indication	34000006
Hidradenitis suppurativa	indication	59393003	DOID:2280
Ulcerative colitis	indication	64766004	DOID:8577
Rheumatoid arthritis	indication	69896004	DOID:7148
Pyoderma gangrenosum	indication	74578003	DOID:8553
Psoriatic arthritis	indication	156370009	DOID:9008
Plaque psoriasis	indication	200965009
Pustular psoriasis	indication	200973000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tumor necrosis factor	Cytokine	P01375	TNFA_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
009871	NDDF
016993	NDDF
017321	NDDF
17071	MMSL
2103477	RXNORM
248487	MMSL
33375	MMSL
33385	MMSL
368840	MMSL
398728003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Abrilada	HUMAN PRESCRIPTION DRUG LABEL	1	61434-053	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	export only	1 sections
Abrilada	HUMAN PRESCRIPTION DRUG LABEL	1	61434-053	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	export only	1 sections
Adalimumab	HUMAN PRESCRIPTION DRUG LABEL	1	61314-327	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	BLA	30 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6411	INJECTION	40 mg	SUBCUTANEOUS	BLA	33 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6428	INJECTION	40 mg	SUBCUTANEOUS	BLA	33 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-399	INJECTION	20 mg	SUBCUTANEOUS	BLA	34 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-400	INJECTION	40 mg	SUBCUTANEOUS	BLA	34 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-410	INJECTION	40 mg	SUBCUTANEOUS	BLA	34 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-411	INJECTION	20 mg	SUBCUTANEOUS	BLA	34 sections
AMJEVITA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-413	INJECTION	10 mg	SUBCUTANEOUS	BLA	34 sections

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