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 |
|---|---|
| infections | D007239 |
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 |
|---|---|---|---|---|
| NYDRAZID | Bristol Myers Squibb | N-008392 DISCN | 1982-01-01 | 1 products |
| ISONIAZID | Epic Pharma | N-008678 DISCN | 1982-01-01 | 2 products, RLD |
| ISONIAZID | Eli Lilly | N-008499 DISCN | 1982-01-01 | 2 products |
| ISONIAZID | Panray Corporation | N-008428 DISCN | 1982-01-01 | 3 products |
| RIMIFON | Roche | N-008420 DISCN | 1982-01-01 | 3 products |
| NYDRAZID | Sandoz | N-008662 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| isoniazid | ANDA | 2024-10-29 |
| isoniazid 300 mg | ANDA | 2023-02-08 |
Indications
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EMA
Agency Specific
FDA
EMA
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Patent Expiration
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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
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Clinical
Clinical Trials
303 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 28 | 86 | 69 | 37 | 70 | 265 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 7 | 42 | 21 | 8 | 11 | 79 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 11 | 15 | 10 | 15 | 51 |
| Latent tuberculosis | D055985 | — | Z22.7 | 7 | 5 | 16 | 9 | 8 | 41 |
| Infections | D007239 | EFO_0000544 | — | 1 | 5 | 13 | 3 | 5 | 25 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 1 | 5 | 9 | 2 | 7 | 21 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 2 | 8 | 2 | 7 | 19 |
| Hiv | D006678 | — | — | 3 | 3 | 6 | 1 | 5 | 17 |
| Communicable diseases | D003141 | — | — | 1 | 2 | 6 | 1 | 5 | 14 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | 2 | 1 | 3 | 6 |
Show 25 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningeal tuberculosis | D014390 | — | A17.0 | 1 | 6 | 2 | — | 1 | 9 |
| Meningitis | D008581 | HP_0001287 | G03 | — | 5 | 2 | — | 1 | 8 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 4 | 2 | — | — | 5 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | 1 | 1 | — | 1 | 3 |
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 1 | 2 | — | 1 | 3 |
| Silicosis | D012829 | EFO_0007485 | J62 | — | — | 1 | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | 1 | — | 1 | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | 1 | — | — | 1 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | 1 | 1 | — | — | 1 |
| Anterior uveitis | D014606 | EFO_1000811 | — | — | — | 1 | — | — | 1 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | 1 | 1 | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | — | — | — | 1 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
| Leg ulcer | D007871 | — | — | — | 1 | — | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | — | 1 |
| Meningoencephalitis | D008590 | EFO_0007364 | A69.22 | — | 1 | — | — | — | 1 |
| Central nervous system tuberculosis | D020306 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | — | — | — | 3 | 3 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 2 | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | — | 1 | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 1 | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 1 | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | — | 1 | 1 |
| Smoking | D012907 | EFO_0004318 | — | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isoniazid |
| INN | isoniazid |
| 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) |  |
| Structure (InChI/SMILES or Protein Sequence) | NNC(=O)c1ccncc1 |
Identifiers
| PDB | — |
| CAS-ID | 54-85-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL64 |
| ChEBI ID | 6030 |
| PubChem CID | 3767 |
| DrugBank | DB00951 |
| UNII ID | V83O1VOZ8L (ChemIDplus, GSRS) |
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Estimated US medical usage
Isoniazid
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Trends
PubMed Central
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Additional graphs summarizing 41,314 documents
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Safety
Black-box Warning
Black-box warning for: Isoniazid
Adverse Events
Top Adverse Reactions
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11,406 adverse events reported
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