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Drug ReportsAmlodipine
Amvaz, Copalia(amlodipine)
Amlodipine, Amlodipine / Valsartan, Amlodipine Besylate, Amlodipine Besylate /, Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil, Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Amlodipine Besylate / Olmesartan Medoxomil, Amlodipine Besylate / Valsartan, Amturnide, Amvaz, Azor, Caduet, Consensi, Copalia, Dafiro, Exforge, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Rasilamlo, Rasitrio, Tekamlo, Tribenzor, Twynsta (amlodipine) is a small molecule pharmaceutical. Amlodipine was first approved as Norvasc on 1992-07-31. It is used to treat coronary artery disease, hypertension, and variant angina pectoris in the USA. It has been approved in Europe to treat hypertension. It is known to target voltage-dependent L-type calcium channel subunit alpha-1D and voltage-dependent L-type calcium channel subunit alpha-1C.
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1M
3M
6M
YTD
1Y
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Katerzia (discontinued: Amlodipine benzoate, Amvaz)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine maleate
Tradename
Company
Number
Date
Products
AMVAZDr Reddys LaboratoriesN-021435 DISCN2003-10-31
3 products
Hide discontinued
Amlodipine benzoate
Tradename
Company
Number
Date
Products
KATERZIAAzurityN-211340 RX2019-07-08
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
amlobenzANDA2010-04-09
amlodipineANDA2022-01-28
amlodipine and atorvastatinNDA authorized generic2024-10-28
amlodipine and benazepril hydrochlorideANDA2024-10-30
amlodipine and benazepril hydrochloride amlodipine besylateANDA2021-08-10
amlodipine and olmesartan medoxomilANDA2024-08-15
amlodipine and valsartanANDA2024-10-18
amlodipine besylateANDA2024-10-30
amlodipine besylate and olmesartran medoxomilANDA2023-01-23
amlodipine besylate and atorvastatin calciumANDA2021-02-16
Show 22 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypertensionEFO_0000537D006973I10
coronary artery disease—D003324I25.1
variant angina pectoris—D000788I20.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Amlodipine Besylate, Norliqva, Cmp Dev Llc
112534742041-02-24DPU-3309, U-3310, U-3311
114580952041-02-24DPU-3309, U-3310, U-3311
117238662041-02-24DPU-3309, U-3310, U-3311
Amlodipine Benzoate, Katerzia, Azurity
107994532039-04-11DP
106953292037-10-16DP
108940392037-10-06U-3, U-185
109529982037-10-06DP
109599912037-10-06U-39, U-158
113642302037-10-06DP
114714092037-10-06U-3447, U-3448
114844982037-10-06DP
117013262037-10-06DP
Amlodipine Besylate / Celecoxib, Consensi, Purple Biotech
103501712038-06-14DP
109258352038-06-14U-2410
109459602038-06-14DP
94088372030-02-28U-2410
96623152029-05-22DPU-2410
Aliskiren Hemifumarate / Amlodipine Besylate, Tekamlo, Novartis
86139492029-12-21DP
Amlodipine Besylate / Perindopril Arginine, Prestalia, Adhera
78469612029-10-05DS, DPU-3
ATC Codes
C: Cardiovascular system drugs
— C07: Beta-adrenergic blocking agents
— C07F: Beta blocking agents, other combinations
— C07FB: Beta blocking agents and calcium channel blockers
— C07FB07: Bisoprolol and amlodipine
— C07FB12: Nebivolol and amlodipine
— C07FB13: Metoprolol and amlodipine
— C08: Calcium channel blockers
— C08C: Selective calcium channel blockers with mainly vascular effects
— C08CA: Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects
— C08CA01: Amlodipine
— C08CA51: Amlodipine and celecoxib
— C08G: Calcium channel blockers and diuretics
— C08GA: Calcium channel blockers and diuretics
— C08GA02: Amlodipine and diuretics
— C09: Agents acting on the renin-angiotensin system
— C09B: Ace inhibitors, combinations
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB03: Lisinopril and amlodipine
— C09BB04: Perindopril and amlodipine
— C09BB07: Ramipril and amlodipine
— C09BB13: Benazepril and amlodipine
— C09BX: Ace inhibitors, other combinations in atc
— C09BX01: Perindopril, amlodipine and indapamide
— C09BX03: Ramipril, amlodipine and hydrochlorothiazide
— C09BX04: Perindopril, bisoprolol and amlodipine
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB01: Valsartan and amlodipine
— C09DB02: Olmesartan medoxomil and amlodipine
— C09DB04: Telmisartan and amlodipine
— C09DB05: Irbesartan and amlodipine
— C09DB06: Losartan and amlodipine
— C09DB07: Candesartan and amlodipine
— C09DB09: Fimasartan and amlodipine
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX01: Valsartan, amlodipine and hydrochlorothiazide
— C09DX03: Olmesartan medoxomil, amlodipine and hydrochlorothiazide
— C09DX06: Candesartan, amlodipine and hydrochlorothiazide
— C09DX07: Irbesartan, amlodipine and hydrochlorothiazide
— C09DX08: Telmisartan, amlodipine and hydrochlorothiazide
— C09X: Other agents acting on the renin-angiotensin system in atc
— C09XA: Renin-inhibitors
— C09XA53: Aliskiren and amlodipine
— C09XA54: Aliskiren, amlodipine and hydrochlorothiazide
— C10: Lipid modifying agents
— C10B: Lipid modifying agents, combinations
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX03: Atorvastatin and amlodipine
— C10BX07: Rosuvastatin, amlodipine and lisinopril
— C10BX09: Rosuvastatin and amlodipine
— C10BX11: Atorvastatin, amlodipine and perindopril
— C10BX14: Rosuvastatin, amlodipine and perindopril
— C10BX18: Atorvastatin, amlodipine and ramipril
— C10BX19: Atorvastatin, amlodipine and candesartan
HCPCS
No data
Clinical
Clinical Trials
695 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10574515918074504
Essential hypertensionD000075222—I1041440251392
Diabetes mellitusD003920HP_0000819E08-E13——421732
HyperlipidemiasD006949HP_0003077E78.513173—24
DyslipidemiasD050171HP_0003119—5—78323
Type 2 diabetes mellitusD003924EFO_0001360E111—214118
StrokeD020521EFO_0000712I63.9—126413
Cardiovascular diseasesD002318HP_0001626—1143413
HypercholesterolemiaD006937HP_0003124———55212
ObesityD009765EFO_0001073E66.923—6111
Show 69 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825HP_0001268G31.84—33—27
ThalassemiaD013789EFO_1001996D56—23—25
Beta-thalassemiaD017086Orphanet_848D56.1—12—24
Iron overloadD019190———12—24
HemorrhageD006470MP_0001914R58——2—13
Cerebral hemorrhageD002543————2—13
Myocardial infarctionD009203EFO_0000612I21——1—23
InfarctionD007238EFO_0009463———1—23
Vascular dementiaD015140—F01——1—12
Erectile dysfunctionD007172EFO_0004234F52.211—1——2
Show 10 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2011——24
Insulin resistanceD007333HP_0000855—11——13
Breast neoplasmsD001943EFO_0003869C5012———2
Triple negative breast neoplasmsD064726——12———2
Abdominal aortic aneurysmD017544EFO_0004214——1——12
AneurysmD000783HP_0002617I72.9—1——12
Aortic aneurysmD001014EFO_0001666I71.9—1——12
Vascular diseasesD014652EFO_0004264I77—1——12
Ventricular remodelingD020257———1———1
Intracranial hypertensionD019586EFO_1000992——1———1
Show 12 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———73———275
MalnutritionD044342EFO_0008572E40-E465————5
Therapeutic equivalencyD013810——3————3
FastingD005215EFO_0002756—2————2
HivD006678——1———12
Drug interactionsD004347——1———12
PharmacokineticsD010599——1———12
Hepatitis cD006526—B19.21————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967HP_0012393T78.40————22
AgingD000375GO_0007568R41.81————22
Orthostatic hypotensionD007024—I95.1————11
Adrenocortical adenomaD018246——————11
Adrenal gland neoplasmsD000310EFO_0003850C74————11
Intracranial arteriosclerosisD002537EFO_1000860I67.2————11
DeliriumD003693—R41.0————11
Emergence deliriumD000071257——————11
Renal dialysisD006435EFO_0010690Z99.2————11
Morbid obesityD009767EFO_0001074—————11
Show 23 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmlodipine
INNamlodipine
Description
Amlodipine is a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. It has a role as an antihypertensive agent, a calcium channel blocker and a vasodilator agent. It is a dihydropyridine, a member of monochlorobenzenes, an ethyl ester, a methyl ester and a primary amino compound.
Classification
Small molecule
Drug classphenylpyridine vasodilators; tricyclic compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Identifiers
PDB—
CAS-ID88150-42-9
RxCUI—
ChEMBL IDCHEMBL1491
ChEBI ID2668
PubChem CID2162
DrugBankDB00381
UNII ID1J444QC288 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CACNA1D
CACNA1D
CACNA1C
CACNA1C
Organism
Homo sapiens
Gene name
CACNA1D
Gene synonyms
CACH3, CACN4, CACNL1A2, CCHL1A2
NCBI Gene ID
776
Protein name
voltage-dependent L-type calcium channel subunit alpha-1D
Protein synonyms
calcium channel, L type, alpha-1 polypeptide, Calcium channel, L type, alpha-1 polypeptide, isoform 2, calcium channel, neuroendocrine/brain-type, alpha 1 subunit, calcium channel, voltage-dependent, L type, alpha 1D subunit, voltage-gated calcium channel alpha 1 subunit, voltage-gated calcium channel alpha subunit Cav1.3, Voltage-gated calcium channel subunit alpha Cav1.3
Uniprot ID
Q9UDC3
Mouse ortholog
Cacna1d (12289)
voltage-dependent L-type calcium channel subunit alpha-1D (Q99246)
Variants
No data
Financial
Revenue by drug
$
€
£
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Exforge – Novartis
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Norvasc – Viatris
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Norvasc – Pfizer
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Prestalia – Adhera Therapeutics
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Caduet – Pfizer
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Estimated US medical usage
Amlodipine
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Aliskiren
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Atorvastatin
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Amlodipine
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Benazepril
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Hydrochlorothiazide
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Olmesartan
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Hydrochlorothiazide
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Valsartan
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Amlodipine
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Olmesartan
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Amlodipine
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Telmisartan
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Valsartan
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Amlobenz, Amlodipine and benazepril hydrochloride, Amlodipine and olmesartan medoxomil, Amlodipine and valsartan, Amlodipine besylate and olmesartran medoxomil, Amlodipine besylate and benazepril hcl, Amlodipine besylate and benazepril hydrochloride, Amlodipine besylate and olmesartan medoxomil, Amlodipine besylate and valsartan, Amlodipine, valsartan and hydrochlorothiazide, Amlodipine, valsartan, hydrochlorothiazide, Azor, Exforge, Exforge hct, Lotrel, Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg olmesartan medoxomil, amlodipine and hydrochlorothiazide 40/10/12.5 mg olmesa..., Prestalia, Telmisartan and amlodipine, Tribenzor
Adverse Events
Top Adverse Reactions
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178,002 adverse events reported
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