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Drug ReportsIsoniazid
Isoniazid
Isoniazid, Rifamate, Rifater (isoniazid) is a small molecule pharmaceutical. Isoniazid was first approved as Nydrazid on 1982-01-01. It is used to treat mycobacterium infections and tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Isoniazid (discontinued: Dow-isoniazid, Hyzyd, Inh, Isoniazid, Laniazid, Nydrazid, Rimifon, Stanozide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isoniazid
Tradename
Company
Number
Date
Products
NYDRAZIDBristol Myers SquibbN-008392 DISCN1982-01-01
1 products
ISONIAZIDEpic PharmaN-008678 DISCN1982-01-01
2 products, RLD
ISONIAZIDEli LillyN-008499 DISCN1982-01-01
2 products
ISONIAZIDPanray CorporationN-008428 DISCN1982-01-01
3 products
RIMIFONRocheN-008420 DISCN1982-01-01
3 products
NYDRAZIDSandozN-008662 DISCN1982-01-01
1 products
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Isoniazid
+
Pyrazinamide
+
Rifampin
Tradename
Company
Number
Date
Products
RIFATERSanofiN-050705 DISCN1994-05-31
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
albuterol sulfate inhalation solutionANDA2024-12-17
albuterol sulfate inhalation solution, 0.5%ANDA2025-03-24
ammoniaunapproved drug other2021-09-02
ammonia inhalantunapproved drug other2020-04-27
ammonia inhalantsunapproved drug other2024-10-28
amoray premium vaporizing inhalerOTC monograph final2016-03-31
arformoterol tartrate inhalationANDA2023-01-24
arformoterol tartrate inhalation solutionANDA2025-02-11
bardown smelling saltsunapproved drug other2025-04-16
berinertBiologic Licensing Application2009-11-10
Show 40 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J04: Antimycobacterials
J04A: Drugs for treatment of tuberculosis
J04AC: Hydrazides for tuberculosis treatment
J04AC01: Isoniazid
J04AC51: Isoniazid, combinations
J04AM: Combinations of drugs for treatment of tuberculosis
J04AM01: Streptomycin and isoniazid
J04AM02: Rifampicin and isoniazid
J04AM03: Ethambutol and isoniazid
J04AM04: Thioacetazone and isoniazid
J04AM05: Rifampicin, pyrazinamide and isoniazid
J04AM06: Rifampicin, pyrazinamide, ethambutol and isoniazid
J04AM07: Rifampicin, ethambutol and isoniazid
J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
No data
Clinical
Clinical Trials
380 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A193194743974285
Pulmonary tuberculosisD014397EFO_1000049A157432481283
Hiv infectionsD015658EFO_0000764B2051417101657
Latent tuberculosisD055985Z22.7951610844
InfectionsD007239EFO_000054427144631
Acquired immunodeficiency syndromeD000163EFO_0000765B201492823
Multidrug-resistant tuberculosisD018088EFO_00073811592822
AngioedemaD000799EFO_0005532T78.31793421
Hereditary angioedemasD054179EFO_00041311783420
HivD006678O98.73361517
Show 40 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory tract infectionsD012141J06.91112
Wounds and injuriesD014947T14.8112
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.1222
HemoglobinuriaD006456R82.322
Type 1 diabetes mellitusD003922EFO_0001359E10111
MalariaD008288EFO_0001068B5411
Traumatic brain injuriesD000070642S0611
Craniocerebral traumaD006259S0011
Brain injuriesD001930S06.911
Graft rejectionD00608411
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients516
Lung diseasesD008171EFO_0003818J98.4112
OsteomyelitisD010019EFO_0003102M8611
Drug interactionsD00434711
MelanomaD00854511
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney transplantationD01603033
Body weightD001835EFO_000433822
ObesityD009765EFO_0001073E66.922
Covid-19D000086382U07.122
Opioid-related disordersD009293EFO_0005611F1111
Addictive behaviorD016739EFO_000434711
Birth weightD001724EFO_000434411
Acute cholecystitisD041881EFO_1001289K81.011
CholecystitisD002764K8111
Acalculous cholecystitisD042101EFO_100079011
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIsoniazid
INNisoniazid
Description
Isoniazide is a carbohydrazide obtained by formal condensation between pyridine-4-carboxylic acid and hydrazine. It has a role as an antitubercular agent and a drug allergen. It is functionally related to an isonicotinic acid.
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NNC(=O)c1ccncc1
Identifiers
PDB
CAS-ID54-85-3
RxCUI
ChEMBL IDCHEMBL64
ChEBI ID6030
PubChem CID3767
DrugBankDB00951
UNII IDV83O1VOZ8L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Isoniazid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 57,704 documents
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Safety
Black-box Warning
Black-box warning for: Feiba, Isoniazid, Provocholine, Provocholine provocholine inhalation solution
Adverse Events
Top Adverse Reactions
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46,962 adverse events reported
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