nitric oxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 1999 FDA INO
Aug. 1, 2001 EMA LINDE HEALTHCARE AB

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
Vitamin B1 decreased 192.87 67.11 30 2988 508 90624921
Blood lactic acid decreased 183.57 67.11 28 2990 414 90625015
Oxygen saturation decreased 176.25 67.11 81 2937 107402 90518027
Hypoxia 175.78 67.11 72 2946 72327 90553102
Cardiac output increased 170.77 67.11 27 2991 510 90624919
Intraventricular haemorrhage neonatal 134.15 67.11 20 2998 251 90625178
Product use issue 130.93 67.11 99 2919 329820 90295609
Patent ductus arteriosus 123.55 67.11 29 2989 4540 90620889
Hyperlactacidaemia 115.77 67.11 27 2991 4109 90621320
Pulmonary hypertensive crisis 108.66 67.11 18 3000 459 90624970
Vitamin B1 increased 102.42 67.11 15 3003 165 90625264
Device failure 102.06 67.11 27 2991 6870 90618559
Underdose 98.77 67.11 44 2974 53973 90571456
Electrocardiogram abnormal 95.74 67.11 28 2990 10270 90615159
Right ventricular failure 94.01 67.11 32 2986 19173 90606256
Bronchopulmonary dysplasia 90.41 67.11 16 3002 608 90624821
Premature delivery 81.98 67.11 35 2983 38727 90586702
Pulmonary hypertension 78.87 67.11 35 2983 42488 90582941
Pneumothorax 78.64 67.11 28 2990 19139 90606290
Pulmonary haemorrhage 75.41 67.11 22 2996 7991 90617438

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 358.74 57.44 145 2502 76606 42542082
Oxygen saturation decreased 182.78 57.44 86 2561 64601 42554087
Device delivery system issue 136.24 57.44 27 2620 1010 42617678
No adverse event 132.38 57.44 59 2588 38962 42579726
Underdose 126.15 57.44 45 2602 16621 42602067
Device issue 108.00 57.44 38 2609 13471 42605217
Pulmonary hypertension 97.40 57.44 41 2606 23528 42595160
Product use in unapproved indication 83.93 57.44 78 2569 184378 42434310
Neonatal hypotension 83.89 57.44 14 2633 194 42618494
Respiratory failure 80.10 57.44 65 2582 128067 42490621
Condition aggravated 79.87 57.44 89 2558 260665 42358023
Drug ineffective 79.55 57.44 140 2507 630057 41988631
Device failure 70.81 57.44 19 2628 2724 42615964
Neonatal disorder 70.61 57.44 15 2632 792 42617896
Hypertrophic cardiomyopathy 66.85 57.44 16 2631 1449 42617239
Device malfunction 66.54 57.44 26 2621 12301 42606387
Pulmonary haemorrhage 64.93 57.44 25 2622 11372 42607316
Pulmonary hypertensive crisis 63.25 57.44 11 2636 197 42618491
Off label use 59.60 57.44 125 2522 638210 41980478
Right ventricular failure 58.16 57.44 22 2625 9533 42609155

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 443.22 54.92 218 3805 311477 110273799
Oxygen saturation decreased 219.49 54.92 109 3914 156873 110428403
Vitamin B1 decreased 173.48 54.92 30 3993 909 110584367
Blood lactic acid decreased 173.08 54.92 28 3995 560 110584716
Hypoxia 166.39 54.92 85 3938 129430 110455846
Cardiac output increased 164.88 54.92 27 3996 584 110584692
Product use in unapproved indication 158.04 54.92 130 3893 447247 110138029
Right ventricular failure 130.07 54.92 45 3978 25909 110559367
Vitamin B1 increased 101.08 54.92 15 4008 165 110585111
Drug ineffective 100.82 54.92 189 3834 1520351 109064925
Respiratory failure 100.56 54.92 74 3949 215258 110370018
Cardiac arrest 99.58 54.92 71 3952 196682 110388594
Hyperlactacidaemia 94.76 54.92 27 3996 8259 110577017
Pulmonary hypertension 94.04 54.92 44 3979 55176 110530100
Off label use 91.39 54.92 180 3843 1500005 109085271
Pulmonary hypertensive crisis 87.12 54.92 15 4008 442 110584834
Device issue 82.85 54.92 35 3988 34500 110550776
Electrocardiogram abnormal 80.59 54.92 29 3994 18680 110566596
Device failure 80.23 54.92 23 4000 7184 110578092
Drug ineffective for unapproved indication 78.47 54.92 48 3975 102790 110482486
Premature delivery 76.67 54.92 32 3991 30600 110554676
Device delivery system issue 69.37 54.92 16 4007 2117 110583159
Pulmonary arterial pressure increased 69.08 54.92 19 4004 5108 110580168
Pulmonary arterial hypertension 68.24 54.92 30 3993 32538 110552738
Pulmonary congestion 66.42 54.92 29 3994 30937 110554339
Pulmonary haemorrhage 65.26 54.92 24 3999 16432 110568844
Condition aggravated 63.40 54.92 103 3920 734733 109850543
No adverse event 62.88 54.92 37 3986 73802 110511474
Pneumothorax 56.61 54.92 27 3996 35258 110550018
Hypotension 55.75 54.92 81 3942 523768 110061508

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 D000975 Antioxidants
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
MeSH PA D016166 Free Radical Scavengers
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D045462 Endothelium-Dependent Relaxing Factors
MeSH PA D064426 Gasotransmitters
FDA EPC N0000175940 Vasodilator
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:25512 neurotransmitter
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:48578 radical scavenger
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:62488 signalling molecule
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:70868 antileishmanial agent
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76971 <em>Escherichia coli</em> metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:86327 antifungal drug
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

R07AX Other respiratory system products 6 drugs

Drug Use | Suggest Off label Use Form| |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 INC N202860 Dec. 20, 2019 RX GAS INHALATION 8057742 Jan. 18, 2026 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM GENOSYL VERO BIOTECH INC 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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
4880PPM INOMAX MALLINCKRODT IRELAND N020845 Jan. 17, 2023 RX GAS INHALATION 11931377 June 30, 2029 A METHOD FOR TREATING A PEDIATRIC PATIENT WHO IS EXPERIENCING IDIOPATHIC PULMONARY ARTERIAL HYPERTENSION RESULTING IN OXYGEN DESATURATION, WHEREIN THE PATIENT IS NOT DEPENDENT ON RIGHT-TO-LEFT SHUNTING OF BLOOD
800PPM INOMAX MALLINCKRODT IRELAND N020845 Dec. 23, 1999 RX GAS INHALATION 11931377 June 30, 2029 A METHOD FOR TREATING A PEDIATRIC PATIENT WHO IS EXPERIENCING IDIOPATHIC PULMONARY ARTERIAL HYPERTENSION RESULTING IN OXYGEN DESATURATION, WHEREIN THE PATIENT IS NOT DEPENDENT ON RIGHT-TO-LEFT SHUNTING OF BLOOD
800PPM INOMAX MALLINCKRODT IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 INC 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND 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 IRELAND N020845 Dec. 23, 1999 RX GAS INHALATION 9279794 Feb. 19, 2035 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 IRELAND 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 NITRIC OXIDE AS COMPARED TO THE DESIRED DELIVERY CONCENTRATION OF NITRIC OXIDE
800PPM GENOSYL VERO BIOTECH INC N202860 Dec. 20, 2019 RX GAS INHALATION 11672938 July 22, 2040 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT

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
31C4KY9ESH INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
INOMAX HUMAN PRESCRIPTION DRUG LABEL 1 64693-003 GAS 6 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
GENOSYL HUMAN PRESCRIPTION DRUG LABEL 1 72385-002 GAS 0.98 mg RESPIRATORY (INHALATION) NDA 26 sections
GENOSYL HUMAN PRESCRIPTION DRUG LABEL 1 72385-003 GAS 0.98 mg RESPIRATORY (INHALATION) NDA 26 sections
Noxivent HUMAN PRESCRIPTION DRUG LABEL 1 72385-102 GAS 800 mg RESPIRATORY (INHALATION) ANDA 16 sections
NOW st HUMAN OTC DRUG LABEL 1 80519-301 LIQUID 1.12 g TOPICAL unapproved drug other 12 sections
Ulspira HUMAN PRESCRIPTION DRUG LABEL 1 82605-006 GAS 0.80 mL RESPIRATORY (INHALATION) ANDA 15 sections
Ulspira HUMAN PRESCRIPTION DRUG LABEL 1 82605-008 GAS 0.80 mL RESPIRATORY (INHALATION) ANDA 2 sections