phentermine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anorexics 2140 122-09-8

Description:

MoleculeDescription

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:

DoseUnitRoute
15 mg O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.19 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ

Approvals:

DateAgencyCompanyOrphan
May 4, 1959 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cholecystitis chronic 170.08 17.22 58 6039 9611 50589416
Injury 87.69 17.22 61 6036 48864 50550163
Gallbladder disorder 75.69 17.22 38 6059 16704 50582323
Emotional distress 69.02 17.22 43 6054 28620 50570407
Anxiety 63.99 17.22 92 6005 177514 50421513
Phospholipidosis 61.54 17.22 10 6087 55 50598972
Carotid artery dissection 58.78 17.22 11 6086 150 50598877
Drug abuse 58.11 17.22 52 6045 59794 50539233
Arteriospasm coronary 54.33 17.22 19 6078 3383 50595644
Subarachnoid haemorrhage 47.35 17.22 24 6073 10752 50588275
Cholelithiasis 47.11 17.22 38 6059 37935 50561092
Psoriasis 44.60 17.22 48 6049 68952 50530075
Deep vein thrombosis 33.99 17.22 43 6054 73261 50525766
Encephalomalacia 32.03 17.22 8 6089 441 50598586
Spinal cord infarction 31.20 17.22 7 6090 242 50598785
Stress cardiomyopathy 27.35 17.22 15 6082 7872 50591155
Anhedonia 27.33 17.22 16 6081 9508 50589519
Biliary dyskinesia 25.14 17.22 10 6087 2540 50596487
Colitis ischaemic 24.78 17.22 15 6082 9468 50589559
Renal vein thrombosis 24.65 17.22 6 6091 297 50598730
Completed suicide 23.30 17.22 50 6047 131839 50467188
Depression 22.94 17.22 57 6040 165366 50433661
Device dislocation 21.44 17.22 19 6078 21527 50577500
Pseudomembranous colitis 20.95 17.22 9 6088 2776 50596251
Subacute cutaneous lupus erythematosus 19.48 17.22 8 6089 2207 50596820
Product dose omission issue 19.13 17.22 57 6040 183781 50415246
Medical device discomfort 18.02 17.22 7 6090 1670 50597357
Cholecystitis acute 17.95 17.22 11 6086 7095 50591932
Amyloidosis 17.67 17.22 6 6091 977 50598050
Pain 17.34 17.22 124 5973 578779 50020248
Pulmonary embolism 17.32 17.22 38 6059 101666 50497361

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 66.06 27.32 36 814 79847 29493830

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cholecystitis chronic 157.55 19.17 50 5532 9237 64483913
Drug abuse 95.28 19.17 84 5498 132290 64360860
Injury 88.59 19.17 57 5525 55935 64437215
Emotional distress 65.30 19.17 40 5542 35998 64457152
Gallbladder disorder 61.95 19.17 30 5552 17000 64476150
Phospholipidosis 57.77 19.17 10 5572 122 64493028
Arteriospasm coronary 55.40 19.17 20 5562 5445 64487705
Carotid artery dissection 54.40 19.17 11 5571 323 64492827
Anxiety 44.67 19.17 70 5512 202579 64290571
Psoriasis 44.64 19.17 42 5540 71661 64421489
Subarachnoid haemorrhage 42.70 19.17 24 5558 18414 64474736
Completed suicide 40.70 19.17 71 5511 224343 64268807
Deep vein thrombosis 39.39 19.17 47 5535 105135 64388015
Cholelithiasis 36.97 19.17 31 5551 45475 64447675
Stress cardiomyopathy 29.77 19.17 15 5567 9242 64483908
Pain 29.70 19.17 110 5472 553401 63939749
Spinal cord infarction 27.69 19.17 7 5575 567 64492583
Encephalomalacia 27.62 19.17 8 5574 1083 64492067
Product dose omission issue 25.86 19.17 54 5528 194693 64298457
Device dislocation 24.98 19.17 18 5564 21160 64471990
Colitis ischaemic 24.56 19.17 15 5567 13399 64479751
Renal vein thrombosis 24.17 19.17 6 5576 451 64492699
Respiratory arrest 22.02 19.17 25 5557 52960 64440190
Anhedonia 21.76 19.17 14 5568 13692 64479458
Biliary dyskinesia 21.51 19.17 8 5574 2364 64490786
Toxicity to various agents 20.92 19.17 74 5508 363439 64129711
Cardio-respiratory arrest 20.27 19.17 33 5549 98360 64394790
Subacute cutaneous lupus erythematosus 19.62 19.17 8 5574 3017 64490133

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A08AA01 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
FDA PE N0000175372 Appetite Suppression
FDA EPC N0000175423 Sympathomimetic Amine Anorectic
MeSH PA D018663 Adrenergic Agents
MeSH PA D019440 Anti-Obesity Agents
MeSH PA D001067 Appetite Depressants
MeSH PA D002491 Central Nervous System Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D013566 Sympathomimetics
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 PE N0000175651 Increased Sympathetic Activity

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

DiseaseRelationSNOMED_IDDOID
Low blood pressure indication 45007003
Obesity indication 414916001 DOID:9970
Hypotension Secondary to Spinal Anesthesia indication
Prevention of Hypotension During 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
Mild pre-eclampsia contraindication 41114007
Conduction disorder of the heart contraindication 44808001
Diabetes mellitus type 1 contraindication 46635009 DOID:9744
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Pulmonary hypertension contraindication 70995007 DOID:6432
Secondary glaucoma contraindication 95717004
Angina pectoris contraindication 194828000
Edema contraindication 267038008
Syncope contraindication 271594007
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
Hypertensive urgency contraindication 443482000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.92 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter INHIBITOR WOMBAT-PK CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.80 WOMBAT-PK

External reference:

IDSource
4019891 VUID
N0000147976 NUI
D05458 KEGG_DRUG
1197-21-3 SECONDARY_CAS_RN
4018166 VANDF
4018167 VANDF
4019891 VANDF
C0031447 UMLSCUI
CHEBI:8080 CHEBI
CHEMBL1574 ChEMBL_ID
DB00191 DRUGBANK_ID
CHEMBL1200912 ChEMBL_ID
D010645 MESH_DESCRIPTOR_UI
4771 PUBCHEM_CID
1064 INN_ID
7269 IUPHAR_LIGAND_ID
C045TQL4WP UNII
221138 RXNORM
1294 MMSL
41147 MMSL
5278 MMSL
5279 MMSL
d00806 MMSL
001864 NDDF
001865 NDDF
001866 NDDF
373343009 SNOMEDCT_US
426428004 SNOMEDCT_US
53480001 SNOMEDCT_US
6394006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0527-1308 CAPSULE 30 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1310 CAPSULE 30 mg ORAL ANDA 26 sections
Phentermine ResinER HUMAN PRESCRIPTION DRUG LABEL 1 0527-1366 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 26 sections
Phentermine ResinER HUMAN PRESCRIPTION DRUG LABEL 1 0527-1398 CAPSULE, EXTENDED RELEASE 15 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1438 CAPSULE 30 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1445 TABLET 37.50 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1742 CAPSULE 15 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1743 CAPSULE 37.50 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-098 CAPSULE 30 mg ORAL ANDA 26 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-099 CAPSULE 15 mg ORAL ANDA 9 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-116 TABLET 37.50 mg ORAL ANDA 9 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-552 TABLET 30 mg ORAL ANDA 31 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-592 CAPSULE 37.50 mg ORAL ANDA 9 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-593 CAPSULE 30 mg ORAL ANDA 19 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-602 TABLET 37.50 mg ORAL ANDA 19 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-620 CAPSULE 30 mg ORAL ANDA 9 sections
LOMAIRA HUMAN PRESCRIPTION DRUG LABEL 1 10702-001 TABLET 8 mg ORAL ANDA 17 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-025 TABLET 37.50 mg ORAL ANDA 25 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-026 CAPSULE 15 mg ORAL ANDA 29 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-027 CAPSULE 30 mg ORAL ANDA 29 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-028 CAPSULE 30 mg ORAL ANDA 29 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-029 CAPSULE 37.50 mg ORAL ANDA 25 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-067 TABLET 8 mg ORAL ANDA 17 sections
Phentermine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 11534-157 CAPSULE 15 mg ORAL ANDA 28 sections
Phentermine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 11534-159 CAPSULE 37.50 mg ORAL ANDA 29 sections
Phentermine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 11534-160 TABLET 37.50 mg ORAL ANDA 29 sections