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

Stem definition	Drug id	CAS RN
	4936	68893-82-3

Description:

Molecule	Description
Synonyms: parathyroid hormone natpara human parathyroid hormone human recombinant parathyroid hormone parathormone ALX1-11 rhPTH parathyrin preotact	A polypeptide hormone (84 amino acid residues) secreted by the PARATHYROID GLANDS which performs the essential role of maintaining intracellular CALCIUM levels in the body. Parathyroid hormone increases intracellular calcium by promoting the release of CALCIUM from BONE, increases the intestinal absorption of calcium, increases the renal tubular reabsorption of calcium, and increases the renal excretion of phosphates. Molecular weight: 9424.76 Formula: C408H674N126O126S2 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 4123.69 ALOGS: ROTB: None

Molecule

Description

Synonyms:

parathyroid hormone
natpara
human parathyroid hormone
human recombinant parathyroid hormone
parathormone
ALX1-11
rhPTH
parathyrin
preotact

A polypeptide hormone (84 amino acid residues) secreted by the PARATHYROID GLANDS which performs the essential role of maintaining intracellular CALCIUM levels in the body. Parathyroid hormone increases intracellular calcium by promoting the release of CALCIUM from BONE, increases the intestinal absorption of calcium, increases the renal tubular reabsorption of calcium, and increases the renal excretion of phosphates.

Molecular weight: 9424.76
Formula: C408H674N126O126S2
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 4123.69
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.10	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company	Orphan
April 24, 2017	EMA	TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH
Jan. 23, 2015	FDA	NPS PHARMS INC

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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
Recalled product	2535.79	32.56	362	5290	1041	63482329
Blood calcium decreased	1318.13	32.56	331	5321	26120	63457250
Hypocalcaemia	1138.94	32.56	306	5346	31407	63451963
Blood calcium abnormal	492.10	32.56	87	5565	1181	63482189
Tetany	366.79	32.56	73	5579	1928	63481442
Inappropriate schedule of product administration	348.18	32.56	174	5478	103791	63379579
Blood calcium increased	333.04	32.56	90	5562	9260	63474110
Muscle spasms	307.76	32.56	184	5468	155966	63327404
Paraesthesia	260.86	32.56	166	5486	156800	63326570
Bone pain	184.01	32.56	92	5560	54549	63428821

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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
Recalled product	434.92	47.68	53	510	294	34956074
Hypocalcaemia	190.24	47.68	49	514	24240	34932128
Blood calcium decreased	154.32	47.68	35	528	10049	34946319
Blood calcium abnormal	67.13	47.68	11	552	557	34955811

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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
Recalled product	1138.06	37.43	161	4136	793	79739298
Blood calcium decreased	1055.24	37.43	260	4037	31559	79708532
Hypocalcaemia	536.67	37.43	169	4128	49755	79690336
Inappropriate schedule of product administration	318.15	37.43	151	4146	133477	79606614
Blood calcium increased	288.55	37.43	74	4223	10326	79729765
Muscle spasms	285.43	37.43	153	4144	174577	79565514
Blood calcium abnormal	256.13	37.43	47	4250	1342	79738749
Tetany	253.63	37.43	52	4245	2676	79737415
Paraesthesia	248.14	37.43	140	4157	176183	79563908
Bone pain	173.18	37.43	76	4221	55666	79684425

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	H05AA03	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS PARATHYROID HORMONES AND ANALOGUES Parathyroid hormones and analogues
FDA CS	M0015931	Parathyroid Hormone
FDA EPC	N0000180851	Parathyroid Hormone
MeSH PA	D000077264	Calcium-Regulating Hormones and Agents

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

Disease	Relation	SNOMED_ID	DOID
Hypoparathyroidism	indication	36976004	DOID:11199

🐶 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
Parathyroid hormone/parathyroid hormone-related peptide receptor	GPCR	Q03431	PTH1R_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
002141	NDDF
1427222	RXNORM
232515	MMSL
23408	MMSL
4034355	VUID
4034355	VANDF
4076007	SNOMEDCT_US
8441	INN_ID
9002-64-6	SECONDARY_CAS_RN
C0030520	UMLSCUI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0202	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0202	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0202	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0202	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0203	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0203	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0203	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0203	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0204	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	75 ug	SUBCUTANEOUS	BLA	30 sections
NATPARA (parathyroid hormone)	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0204	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	75 ug	SUBCUTANEOUS	BLA	30 sections

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