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

Stem definition	Drug id	CAS RN
	2646	51-48-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: levothyroxine sodium anhydrous levothyroxine sodium pentahydrate L-Thyroxine thyroxin sodium thyroxine sodium levothyroxine sodium tetraiodothyronine thyroxine levothyroxine levothyroxin natrium T4 levothyroxine sodium hydrate	The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism. Molecular weight: 776.87 Formula: C15H11I4NO4 CLOGP: 3.21 LIPINSKI: 1 HAC: 5 HDO: 3 TPSA: 92.78 ALOGS: -4.94 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

levothyroxine sodium anhydrous
levothyroxine sodium pentahydrate
L-Thyroxine
thyroxin sodium
thyroxine sodium
levothyroxine sodium
tetraiodothyronine
thyroxine
levothyroxine
levothyroxin natrium
T4
levothyroxine sodium hydrate

The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

Molecular weight: 776.87
Formula: C15H11I4NO4
CLOGP: 3.21
LIPINSKI: 1
HAC: 5
HDO: 3
TPSA: 92.78
ALOGS: -4.94
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.15	mg	O
0.15	mg	P

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Aug. 21, 2000	FDA	STEVENS J
Jan. 23, 2020	PMDA	Aska Pharmaceutical Co., Ltd

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
Pemphigus	1598.60	10.75	130	720992	183596	62584304
Systemic lupus erythematosus	1283.24	10.75	389	720733	208529	62559371
Glossodynia	1227.06	10.75	266	720856	178610	62589290
Contraindicated product administered	1120.86	10.75	535	720587	217113	62550787
Drug ineffective	1081.45	10.75	7206	713916	1037559	61730341
Hand deformity	1028.91	10.75	270	720852	159187	62608713
Blood thyroid stimulating hormone increased	930.94	10.75	721	720401	6473	62761427
Synovitis	926.80	10.75	483	720639	186435	62581465
Anti-cyclic citrullinated peptide antibody positive	903.69	10.75	124	720998	116088	62651812
Treatment failure	885.54	10.75	586	720536	198457	62569443

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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
Hypothyroidism	373.04	10.23	522	196621	20380	34739408
Blood thyroid stimulating hormone increased	291.55	10.23	220	196923	4035	34755753
Drug abuse	285.61	10.23	101	197042	98995	34660793
Drug ineffective	247.49	10.23	1538	195605	455213	34304575
Foetal exposure during pregnancy	213.13	10.23	582	196561	37519	34722269
Toxicity to various agents	210.46	10.23	516	196627	199846	34559942
Off label use	175.68	10.23	1519	195624	418005	34341783
Atrial septal defect	169.69	10.23	209	196934	7183	34752605
Craniopharyngioma	127.99	10.23	52	197091	247	34759541
Febrile neutropenia	125.79	10.23	376	196767	136473	34623315

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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
Hypothyroidism	801.88	10.24	1604	735631	50788	78956365
Blood thyroid stimulating hormone increased	772.88	10.24	673	736562	9035	78998118
Drug ineffective	748.31	10.24	6404	730831	1074509	77932644
Pemphigus	528.81	10.24	134	737101	99448	78907705
Off label use	494.87	10.24	5689	731546	901526	78105627
Drug abuse	478.85	10.24	478	736757	162213	78844940
Synovitis	457.39	10.24	431	736804	150303	78856850
Toxicity to various agents	454.49	10.24	2177	735058	419363	78587790
Anti-cyclic citrullinated peptide antibody positive	431.70	10.24	117	737118	83026	78924127
Treatment failure	424.03	10.24	573	736662	169913	78837240

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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
Small for dates baby	30.84	17.65	147	2165	2662	84818
Premature baby	28.90	17.65	36	2276	3892	83588
Atrial septal defect	19.51	17.65	141	2171	2978	84502

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Pharmacologic Action:

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Source	Code	Description
ATC	H03AA01	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS THYROID THERAPY THYROID PREPARATIONS Thyroid hormones
ATC	H03AA51	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS THYROID THERAPY THYROID PREPARATIONS Thyroid hormones
CHEBI has role	CHEBI:50671	antithyroid drugs
CHEBI has role	CHEBI:60311	thyroid hormones
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:52290	mitogens
CHEBI has role	CHEBI:53000	epitope role
FDA CS	M0021504	Thyroxine
FDA EPC	N0000175945	l-Thyroxine

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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
Goiter	indication	3716002	DOID:12176
Hashimoto thyroiditis	indication	21983002
Hypothyroidism	indication	40930008	DOID:1459
Myxedema	indication	43153006	DOID:11634
Hyperlipidemia	indication	55822004	DOID:1168
Congenital hypothyroidism	indication	190268003	DOID:0050328
Malignant tumor of thyroid gland	indication	363478007	DOID:1781
Diagnostic Test for Thyroid Dysfunction	indication
Myxedema coma	off-label use	21263006
Myocardial infarction	contraindication	22298006	DOID:5844

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🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Replacement therapy for diminished thyroid function	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Thyro-Tabs Canine	Lloyd Inc.	1
ThyroKare	Neogen Corp.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.08	acidic
pKa2	6.63	acidic
pKa3	8.6	Basic

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
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	LEVOXYL	KING PHARMS	N021301	May 25, 2001	RX	TABLET	ORAL	7101569	Oct. 2, 2023	METHOD OF USE OF ADMINISTERING LEVOTHYROXINE

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Thyroid hormone receptor alpha	Nuclear hormone receptor	P10827	THA_HUMAN	AGONIST	EC50	7.72	CHEMBL	IUPHAR
Thyroid hormone receptor beta	Nuclear hormone receptor	P10828	THB_HUMAN	AGONIST	IC50	8.52	IUPHAR	CHEMBL
Transthyretin	Secreted	P02766	TTHY_HUMAN		IC50	4.98	CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN		Kd	6.40	CHEMBL
Retinoic acid receptor RXR-alpha	Nuclear hormone receptor	P19793	RXRA_HUMAN		Kd	6.03	CHEMBL
Bile acid receptor	Nuclear hormone receptor	Q96RI1	NR1H4_HUMAN		IC50	5.10	CHEMBL
THAP domain-containing protein 1	Unclassified	Q9NVV9	THAP1_HUMAN				WOMBAT-PK
Macrophage migration inhibitory factor	Unclassified	P14174	MIF_HUMAN		IC50	4.80	CHEMBL
Malate dehydrogenase, mitochondrial	Enzyme	P40926	MDHM_HUMAN		IC50	4.36	CHEMBL
Thyroid hormone receptor beta	Transcription factor		THB_RAT		IC50	7.46	CHEMBL

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External reference:

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ID	Source
002132	NDDF
004881	NDDF
005896	NDDF
10582	RXNORM
126202002	SNOMEDCT_US
1842	MMSL
38076006	SNOMEDCT_US
4017826	VUID
4017826	VANDF
4022126	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3727	TABLET	137 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3727	TABLET	137 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3727	TABLET	137 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4341	TABLET	25 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4341	TABLET	25 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4341	TABLET	25 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4552	TABLET	50 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4552	TABLET	50 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-4552	TABLET	50 ug	ORAL	NDA	26 sections
Synthroid	HUMAN PRESCRIPTION DRUG LABEL	1	0074-5182	TABLET	75 ug	ORAL	NDA	26 sections

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