nitric oxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1948 10102-43-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nitric oxide
  • nitrogen oxide
  • nitrogen monoxide
  • INOmax
A free radical gas produced endogenously by a variety of mammalian cells, synthesized from ARGININE by NITRIC OXIDE SYNTHASE. Nitric oxide is one of the ENDOTHELIUM-DEPENDENT RELAXING FACTORS released by the vascular endothelium and mediates VASODILATION. It also inhibits platelet aggregation, induces disaggregation of aggregated platelets, and inhibits platelet adhesion to the vascular endothelium. Nitric oxide activates cytosolic GUANYLATE CYCLASE and thus elevates intracellular levels of CYCLIC GMP. It has been shown to have in vitro activity against severe acute res-piratory syndrome corona-virus (SARS-CoV-1) but evidence supporting the use of inhaled nitric oxide in COVID-19 patients is currently limited.
  • Molecular weight: 30.01
  • Formula: NO
  • CLOGP: 0.74
  • LIPINSKI: None
  • HAC: 2
  • HDO: 0
  • TPSA: 34.14
  • ALOGS:
  • ROTB: 0

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 1999 FDA INO

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
Intraventricular haemorrhage neonatal 140.71 53.43 19 1318 143 50603644
Oxygen saturation decreased 108.87 53.43 48 1289 73200 50530587
Device failure 83.64 53.43 21 1316 5507 50598280
Patent ductus arteriosus 75.53 53.43 18 1319 3802 50599985
Product use issue 57.06 53.43 40 1297 149435 50454352
Pneumothorax 56.30 53.43 19 1318 14015 50589772

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
Product use issue 141.13 59.37 62 1368 51382 29521715
Oxygen saturation decreased 109.78 59.37 50 1380 44887 29528210
Device delivery system issue 94.48 59.37 16 1414 318 29572779
No adverse event 89.15 59.37 33 1397 17445 29555652
Neonatal disorder 74.47 59.37 15 1415 788 29572309
Off label use 70.72 59.37 79 1351 300721 29272376
Device issue 68.05 59.37 22 1408 7758 29565339
Hypertrophic cardiomyopathy 67.27 59.37 14 1416 865 29572232
Device failure 65.80 59.37 16 1414 2000 29571097
Pulmonary haemorrhage 64.27 59.37 22 1408 9248 29563849
Product use in unapproved indication 64.12 59.37 44 1386 86831 29486266
Pulmonary hypertension 62.58 59.37 26 1404 18582 29554515

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
Product use issue 206.26 51.81 95 1721 151620 64345296
Product use in unapproved indication 118.60 51.81 69 1747 176549 64320367
Oxygen saturation decreased 111.37 51.81 56 1760 107120 64389796
Off label use 101.22 51.81 105 1711 632701 63864215
Device failure 71.99 51.81 19 1797 5673 64491243
Right ventricular failure 68.82 51.81 25 1791 21446 64475470
Cardiac arrest 62.72 51.81 44 1772 154020 64342896
Pulmonary arterial hypertension 57.71 51.81 23 1793 25344 64471572
Pulmonary hypertension 55.04 51.81 26 1790 43113 64453803

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R07AX01 RESPIRATORY SYSTEM
OTHER RESPIRATORY SYSTEM PRODUCTS
OTHER RESPIRATORY SYSTEM PRODUCTS
Other respiratory system products
FDA PE N0000009909 Vasodilation
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000975 Antioxidants
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D045462 Endothelium-Dependent Relaxing Factors
MeSH PA D016166 Free Radical Scavengers
MeSH PA D064426 Gasotransmitters
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D014665 Vasodilator Agents
FDA EPC N0000175940 Vasodilator
CHEBI has role CHEBI:25512 neurotransmitters
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:48578 free radical scavengers
CHEBI has role CHEBI:62488 signal molecules
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:76971 Escherichia coli metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pulmonary hypertension indication 70995007 DOID:6432
Persistent pulmonary hypertension of the newborn indication 233815004 DOID:13042
Methemoglobinemia contraindication 38959009 DOID:10783
Left heart failure contraindication 85232009
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 10124142 Aug. 18, 2025 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 8226916 Aug. 18, 2025 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 8609028 Aug. 18, 2025 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 9956373 Aug. 18, 2025 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 10814092 Oct. 17, 2025 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 8057742 Jan. 18, 2026 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 7947227 Oct. 17, 2026 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8282966 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8293284 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8431163 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8795741 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8846112 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8282966 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8293284 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8431163 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8795741 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8846112 June 30, 2029 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM GENOSYL VERO BIOTECH N202860 Dec. 20, 2019 RX GAS INHALATION 9604028 Aug. 13, 2029 A METHOD FOR DELIVERING NITRIC OXIDE TO A PATIENT WITH PULMONARY HYPERTENSION OR HYPOXIA
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8291904 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8573210 Jan. 6, 2031 A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8776794 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 DISCN GAS INHALATION 8776795 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8291904 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8573210 Jan. 6, 2031 A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8776794 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 8776795 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 9265911 Jan. 6, 2031 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 9295802 Jan. 6, 2031 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 9408993 Jan. 6, 2031 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 9279794 Feb. 19, 2034 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY COMPENSATING LONG-TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS USED IN SYSTEMS FOR DELIVERING THERAPEUTIC NITRIC OXIDE TO A PATIENT
800PPM INOMAX MALLINCKRODT HOSP N020845 Dec. 23, 1999 RX GAS INHALATION 9770570 May 3, 2036 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY MEASURING AND DISPLAYING AN INDICATION OF THE CALCULATED DELIVERY CONCENTRATION OF NITIRIC OXIDE AS COMPARED TO THE DESIRED DELIVERY CONCENTRATION OF NITRIC OXIDE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Soluble guanylate cyclase Enzyme ACTIVATOR CHEMBL CHEMBL

External reference:

IDSource
31C4KY9ESH UNII
4021248 VUID
N0000148689 NUI
D00074 KEGG_DRUG
4021248 VANDF
C0028128 UMLSCUI
CHEBI:16480 CHEBI
NO PDB_CHEM_ID
CHEMBL1200689 ChEMBL_ID
145068 PUBCHEM_CID
DB00435 DRUGBANK_ID
D009569 MESH_DESCRIPTOR_UI
405139 RXNORM
17479 MMSL
47106 MMSL
d04508 MMSL
012088 NDDF
409378005 SNOMEDCT_US
6710000 SNOMEDCT_US
CHEMBL1234579 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Noxivent 101 HUMAN PRESCRIPTION DRUG LABEL 1 59579-101 GAS 100 mg RESPIRATORY (INHALATION) ANDA 16 sections
Noxivent 102 HUMAN PRESCRIPTION DRUG LABEL 1 59579-102 GAS 800 mg RESPIRATORY (INHALATION) ANDA 16 sections
INOmax HUMAN PRESCRIPTION DRUG LABEL 1 64693-002 GAS 0.98 mg RESPIRATORY (INHALATION) NDA 23 sections
Nitric Oxide Nitrogen Mix HUMAN PRESCRIPTION DRUG LABEL 2 67989-011 GAS 5 mL RESPIRATORY (INHALATION) unapproved medical gas 1 sections
GENOSYL HUMAN PRESCRIPTION DRUG LABEL 1 72385-001 GAS 0.98 mg RESPIRATORY (INHALATION) NDA 23 sections
NOW st HUMAN OTC DRUG LABEL 1 80519-301 LIQUID 1.12 g TOPICAL unapproved drug other 12 sections