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

Stem definition	Drug id	CAS RN
anorexics	2140	122-09-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: phentermine duromine normephentermine phentermine hydrochloride phentermine HCl phentermine resin complex	A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity. Molecular weight: 149.24 Formula: C10H15N CLOGP: 2.14 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 26.02 ALOGS: -2.29 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

phentermine
duromine
normephentermine
phentermine hydrochloride
phentermine HCl
phentermine resin complex

A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity.

Molecular weight: 149.24
Formula: C10H15N
CLOGP: 2.14
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 26.02
ALOGS: -2.29
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.19 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
S (Water solubility)	2 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
May 4, 1959	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
Cholecystitis chronic	172.57	17.09	58	6772	10303	63471889
Gallbladder disorder	75.50	17.09	38	6792	18804	63463388
Emotional distress	73.53	17.09	45	6785	32504	63449688
Injury	71.93	17.09	61	6769	73186	63409006
Arteriospasm coronary	65.19	17.09	22	6808	3946	63478246
Carotid artery dissection	64.92	17.09	12	6818	172	63482020
Anxiety	64.72	17.09	97	6733	217444	63264748
Drug abuse	62.35	17.09	56	6774	72462	63409730
Phospholipidosis	52.78	17.09	10	6820	165	63482027
Psoriasis	50.17	17.09	54	6776	86903	63395289

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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 abuse	59.19	27.03	36	955	99060	34856880

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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
Cholecystitis chronic	159.70	18.72	50	6140	9856	79728342
Drug abuse	95.93	18.72	88	6102	162603	79575595
Injury	77.40	18.72	57	6133	77439	79660759
Emotional distress	68.06	18.72	41	6149	39928	79698270
Arteriospasm coronary	64.66	18.72	23	6167	6693	79731505
Gallbladder disorder	61.41	18.72	30	6160	19310	79718888
Carotid artery dissection	60.89	18.72	12	6178	345	79737853
Completed suicide	56.97	18.72	82	6108	245685	79492513
Phospholipidosis	53.05	18.72	10	6180	226	79737972
Psoriasis	46.10	18.72	45	6145	89542	79648656

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A08AA01	ALIMENTARY TRACT AND METABOLISM ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Centrally acting antiobesity products
ATC	A08AA51	ALIMENTARY TRACT AND METABOLISM ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Centrally acting antiobesity products
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:35470	central nervous system agents
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:48560	dopaminergic agents
FDA EPC	N0000175423	Sympathomimetic Amine Anorectic
FDA PE	N0000175372	Appetite Suppression
FDA PE	N0000175651	Increased Sympathetic Activity

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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
Low blood pressure	indication	45007003
Obesity	indication	414916001	DOID:9970
Prevention of Hypotension During Spinal Anesthesia	indication
Hypotension Secondary to Spinal Anesthesia	indication
Heart valve disorder	contraindication	368009	DOID:4079
Alcoholism	contraindication	7200002
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763

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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	9.92	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
EQ 11.25MG BASE;69MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8895057	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	9011906	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8580299	June 14, 2029	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 15MG BASE;92MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8895057	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	9011906	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8580299	June 14, 2029	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 3.75MG BASE;23MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8895057	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	9011906	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8580299	June 14, 2029	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 7.5MG BASE;46MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	8895057	June 9, 2028	FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)

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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
EQ 11.25MG BASE;69MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 24, 2025	NEW PATIENT POPULATION
EQ 15MG BASE;92MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 24, 2025	NEW PATIENT POPULATION
EQ 3.75MG BASE;23MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 24, 2025	NEW PATIENT POPULATION
EQ 7.5MG BASE;46MG	QSYMIA	VIVUS	N022580	July 17, 2012	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 24, 2025	NEW PATIENT POPULATION

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR				WOMBAT-PK	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.80		WOMBAT-PK

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External reference:

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ID	Source
001864	NDDF
001865	NDDF
001866	NDDF
1064	INN_ID
1197-21-3	SECONDARY_CAS_RN
1294	MMSL
221138	RXNORM
373343009	SNOMEDCT_US
4018166	VANDF
4018167	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LOMAIRA	HUMAN PRESCRIPTION DRUG LABEL	1	10702-001	TABLET	8 mg	ORAL	ANDA	17 sections
phentermine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0644	CAPSULE	15 mg	ORAL	ANDA	29 sections
phentermine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0647	CAPSULE	30 mg	ORAL	ANDA	29 sections
phentermine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0185-5000	CAPSULE	30 mg	ORAL	ANDA	29 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-0597	CAPSULE	30 mg	ORAL	ANDA	26 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-0597	CAPSULE	30 mg	ORAL	ANDA	26 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1308	CAPSULE	30 mg	ORAL	ANDA	26 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1308	CAPSULE	30 mg	ORAL	ANDA	26 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1310	CAPSULE	30 mg	ORAL	ANDA	26 sections
Phentermine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1310	CAPSULE	30 mg	ORAL	ANDA	26 sections

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