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Drug ReportsSpironolactone
Aldactazide, Qaialdo(spironolactone)
Aldactazide, Aldactone, Carospir, Qaialdo, Spironolactone (spironolactone) is a small molecule pharmaceutical. Spironolactone was first approved as Spironolactone and hydrochlorothiazide on 1982-01-01. It is used to treat ascites, edema, heart failure, hirsutism, and hyperaldosteronism amongst others in the USA. It has been approved in Europe to treat ascites, edema, essential hypertension, heart failure, and hyperaldosteronism amongst others. The pharmaceutical is active against mineralocorticoid receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
urogenital diseasesD000091642
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Aldactone, Carospir, Spironolactone (discontinued: Spironolactone)
Combinations
Aldactazide, Spironolactone hydrochlorothiazide (discontinued: Aldactazide, Spironolactone hydrochlorothiazide, Spironolactone w/ hydrochlorothiazide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Spironolactone
Tradename
Company
Number
Date
Products
ALDACTAZIDEPfizerN-012616 RX1982-12-30
1 products, RLD
Show 1 discontinued
Spironolactone
Tradename
Company
Number
Date
Products
CAROSPIRCMP PharmaN-209478 RX2017-08-04
1 products, RLD, RS
ALDACTONEPfizerN-012151 RX1982-12-30
3 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
011054 niacinamide 4% / spironolactone 5%unapproved drug other2020-07-02
011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025%unapproved drug other2020-07-02
011220 niacinamide 2% / spironolactone 5% / tretinoin 0.05%unapproved drug other2020-07-02
011503 dapsone 6% / niacinamide 2% / spironolactone 5%unapproved drug other2020-07-02
aldactoneNew Drug Application2024-12-23
benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2%unapproved drug other2019-05-10
benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.025%unapproved drug other2019-05-03
benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.05%unapproved drug other2019-05-02
carospirNew Drug Application2024-04-12
clindamycin 1% / niacinamide 4% / spironolactone 2% / tretinoin 0.025%unapproved drug other2020-06-04
Show 8 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
hypertensionEFO_0000537D006973I10
hyperaldosteronism—D006929E26
edema—D004487R60.9
hypokalemia—D007008E87.6
ascites—D001201R18
hirsutism—D006628L68.0
nephrotic syndromeEFO_0004255D009404N04
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Spironolactone, Carospir, Cmp Dev Llc
97573942036-10-28DPU-2109
104930832036-10-28DP
106249062036-10-28DP
106609072036-10-28DP
108885702036-10-28DP
113894612036-10-28DP
113958282036-10-28U-2109, U-3401, U-3402
114911662036-10-28DP
ATC Codes
C: Cardiovascular system drugs
— C03: Diuretics
— C03D: Aldosterone antagonists and other potassium-sparing agents
— C03DA: Aldosterone antagonists
— C03DA01: Spironolactone
HCPCS
No data
Clinical
Clinical Trials
296 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_0000537I10———112
HypercholesterolemiaD006937—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I50——1——1
Type 2 diabetes mellitusD003924EFO_0001360E11——1——1
Diabetes mellitusD003920EFO_0000400E08-E13——1——1
Glucose intoleranceD018149HP_0000833R73.03——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Diabetic nephropathiesD003928EFO_0000401—1————1
Kidney diseasesD007674EFO_0003086N081————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSpironolactone
INNspironolactone
Description
Spironolactone is a steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. It has a role as a diuretic, an aldosterone antagonist, an antihypertensive agent, an environmental contaminant and a xenobiotic. It is a steroid lactone, an oxaspiro compound, a thioester and a 3-oxo-Delta(4) steroid.
Classification
Small molecule
Drug classAntimineralocorticoid; Steroidal antiandrogen
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)S[C@@H]1CC2=CC(=O)CC[C@]2(C)[C@H]2CC[C@@]3(C)[C@@H](CC[C@@]34CCC(=O)O4)[C@@H]21
Identifiers
PDB—
CAS-ID52-01-7
RxCUI—
ChEMBL IDCHEMBL1393
ChEBI ID9241
PubChem CID5833
DrugBankDB00421
UNII ID27O7W4T232 (ChemIDplus, GSRS)
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
4306
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Q96KQ9
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Spironolactone
+
Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Spironolactone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,921 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,804 adverse events reported
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