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Inomax (Nitric Oxide Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Inomax (Nitric Oxide Inhalation) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (41)
Death (25)
Life Threatening Events (10)

Reports by Reaction Type

Oxygen Saturation Decreased (17)Cardio-Respiratory Arrest (9)Device Failure (8)Off Label Use (5)Device Malfunction (4)Acidosis (3)Pneumothorax (3)Blood Pressure Decreased (3)Pulmonary Hypertension (2)Patent Ductus Arteriosus (2)Cardiac Murmur (2)Hypotension (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Inomax (Nitric Oxide Inhalation). For a complete list or a specific selection of reports, please use the links above.

Possible Inomax side effects in 4 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: 4 month old female

Reactions: Surgery, Complication of Device Insertion, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10

Patient: 61 year old female

Reactions: Medical Device Complication, Heart Rate Decreased, Device Alarm Issue, General Physical Health Deterioration, Cardiac Arrest, Oxygen Saturation Decreased, Cough

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm, continuous, inhalation, 40 ppm, continuous, inhalation, 60 ppm, continuous, inhalation
    Indication: Oxygen Saturation Increased
    Start date: 2012-06-22
    End date: 2012-06-01

Inomax
    Dosage: 20 ppm, continuous, inhalation, 40 ppm, continuous, inhalation, 60 ppm, continuous, inhalation
    Indication: Oxygen Saturation Increased
    Start date: 2012-06-01
    End date: 2012-06-01

Inomax
    Dosage: 20 ppm, continuous, inhalation, 40 ppm, continuous, inhalation, 60 ppm, continuous, inhalation
    Indication: Oxygen Saturation Increased
    Start date: 2012-06-01
    End date: 2012-06-23



Possible Inomax side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-31

Patient: 40 year old female

Reactions: Withdrawal of Life Support

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 81 year old female

Reactions: Cardio-Respiratory Arrest, Ventricular Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Pulmonary Hypertension
    Start date: 2012-05-15
    End date: 2012-05-15

Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Cardiac Operation
    Start date: 2012-05-15
    End date: 2012-05-15

Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Pulmonary Hypertension
    Start date: 2012-05-13
    End date: 2012-05-15

Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Cardiac Operation
    Start date: 2012-05-13
    End date: 2012-05-15

Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Pulmonary Hypertension
    Start date: 2012-05-15
    End date: 2012-05-21

Inomax
    Dosage: 80 ppm, continuous, inhalation, 60 ppm, continuous, inhalation,
    Indication: Cardiac Operation
    Start date: 2012-05-15
    End date: 2012-05-21



Possible Inomax side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: 19 year old female, weighing 77.0 kg (169.4 pounds)

Reactions: Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm, continuous, inhalation
    Indication: Hypoxia
    Start date: 2012-03-11
    End date: 2012-03-12

Inomax
    Dosage: 20 ppm, continuous, inhalation
    Indication: Hypoxia
    Start date: 2012-03-08
    End date: 2012-03-11



Possible Inomax side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient:

Reactions: Heart Rate Decreased, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-22

Patient: female

Reactions: Device Failure, Gastrointestinal Haemorrhage, Persistent Foetal Circulation, Withdrawal of Life Support, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-15

Patient: male

Reactions: Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 40 ppm, continuous, inhalation
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-28
    End date: 2012-04-29

Inomax
    Dosage: 40 ppm, continuous, inhalation
    Indication: Oxygen Saturation Decreased
    Start date: 2012-04-28
    End date: 2012-04-29



Possible Inomax side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: 38 year old male

Reactions: Cardio-Respiratory Arrest, Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09

Patient: female

Reactions: Off Label Use, Cardio-Respiratory Arrest, Blood PH Decreased, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Hydrocortione (Hydrocortisone); Caffeine Citrate; Oxygen (Oxygen); Clindamycin; Dobutamine (Dobutamine); Vancomyci (Vancomycin); Dopamine HCL; Doxapram (Doxapram); Albumin (Human); Gentamicin



Possible Inomax side effects in 27 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09

Patient: 27 year old male

Reactions: Pulmonary Haemorrhage, Off Label Use, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Oxygen Saturation Decreased
    End date: 2012-04-20

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Acute Respiratory Distress Syndrome
    End date: 2012-04-20

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Oxygen Saturation Decreased
    Start date: 2012-04-15

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Acute Respiratory Distress Syndrome
    Start date: 2012-04-15

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Oxygen Saturation Decreased
    Start date: 2012-04-15
    End date: 2012-04-15

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Acute Respiratory Distress Syndrome
    Start date: 2012-04-15
    End date: 2012-04-15

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Oxygen Saturation Decreased
    Start date: 2012-04-20
    End date: 2012-04-28

Inomax
    Dosage: 20 ppm, continuous, inhalation 40, inhalation 5, inhalation
    Indication: Acute Respiratory Distress Syndrome
    Start date: 2012-04-20
    End date: 2012-04-28

Other drugs received by patient: Broad Spectrum Antibiotics



Possible Inomax side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-17

Patient: 59 year old female

Reactions: Brain Death, Off Label Use, Therapeutic Response Decreased, Brain Oedema, Drug Administration Error, Shock, Renal Failure Acute, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 40 ppm; cont; inh
    Indication: Oxygen Saturation Decreased
    Start date: 2012-03-31
    End date: 2012-03-31

Inomax
    Dosage: 40 ppm; cont; inh
    Indication: Pulmonary Hypertension
    Start date: 2012-03-31
    End date: 2012-03-31

Inomax
    Dosage: 40 ppm; cont; inh
    Indication: Pulmonary Hypertension
    Start date: 2012-03-31
    End date: 2012-03-31

Inomax
    Dosage: 40 ppm; cont; inh
    Indication: Oxygen Saturation Decreased
    Start date: 2012-03-31
    End date: 2012-03-31



Possible Inomax side effects in 66 year old male

Reported by a individual with unspecified qualification from United States on 2012-04-04

Patient: 66 year old male

Reactions: Off Label Use, Cardio-Respiratory Arrest, Pulmonary Embolism, Atrial Fibrillation, Blood Pressure Decreased, Device Malfunction, Pulseless Electrical Activity

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Inomax
    Dosage: 10 ppm;cont;inh, 5 ppm;cont;inh, 4 ppm;cont, 10 ppm;cont, 20 ppm;cont,
    Indication: Pulmonary Hypertension
    Start date: 2012-03-19
    End date: 2012-03-20

Inomax
    Dosage: 10 ppm;cont;inh, 5 ppm;cont;inh, 4 ppm;cont, 10 ppm;cont, 20 ppm;cont,
    Indication: Pulmonary Hypertension
    Start date: 2012-03-20
    End date: 2012-03-20

Inomax
    Dosage: 10 ppm;cont;inh, 5 ppm;cont;inh, 4 ppm;cont, 10 ppm;cont, 20 ppm;cont,
    Indication: Pulmonary Hypertension
    Start date: 2012-03-20
    End date: 2012-03-21

Inomax
    Dosage: 10 ppm;cont;inh, 5 ppm;cont;inh, 4 ppm;cont, 10 ppm;cont, 20 ppm;cont,
    Indication: Pulmonary Hypertension
    Start date: 2012-03-16
    End date: 2012-03-19

Inomax
    Dosage: 10 ppm;cont;inh, 5 ppm;cont;inh, 4 ppm;cont, 10 ppm;cont, 20 ppm;cont,
    Indication: Pulmonary Hypertension
    Start date: 2012-03-19
    End date: 2012-03-19

Other drugs received by patient: Vasopressin Injection; Tazobactam; Piperacillin W /; Vancomycin



Possible Inomax side effects in 19 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-30

Patient: 19 year old male

Reactions: Off Label Use, FAT Embolism, Blood Pressure Decreased, Oxygen Saturation Decreased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Zemuron; Sodium Bicarbonate; Piperacillin and Tazobactam; Epinephrine; Sodium Chloride; Voluven; Versed; Solu-Cortef; Levophed; Fentanyl; Lactated Ringer's; Vasopressin Injection



Possible Inomax side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-16

Patient: 50 year old male

Reactions: Anoxia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm;cont;inh
    Indication: Cardiopulmonary Failure
    Start date: 2012-03-07
    End date: 2012-03-08

Inomax
    Dosage: 20 ppm;cont;inh
    Indication: Oxygen Saturation Decreased
    Start date: 2012-03-07
    End date: 2012-03-08



Possible Inomax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-13

Patient: male

Reactions: Drug Ineffective, Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07

Patient: female, weighing 1.0 kg (2.2 pounds)

Reactions: Intraventricular Haemorrhage Neonatal

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Oxygen; Survanta



Possible Inomax side effects in male

Reported by a physician from United States on 2012-03-07

Patient: male, weighing 0.8 kg (1.8 pounds)

Reactions: Cardiac Murmur, Haematuria, Condition Aggravated, Neonatal Hypotension, Acidosis, Neonatal Anuria, Atelectasis Neonatal, Pulmonary Interstitial Emphysema Syndrome, Patent Ductus Arteriosus, Sepsis Neonatal, Pulmonary Eosinophilia, Pneumothorax, Abdominal Distension, Antibiotic Level Above Therapeutic

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Rocuronium Bromide; Fluconazole; Epinephrine; Sodium Bicarbonate; Atropine; Indocin; Cefotaxime; Furosemide; Ampicillin; Furosemide; Versed; Ketamine HCL; Normal-Serum-Albumin (Human); Ampicillin; Ampicillin; Sodium Bicarbonate; Fentanyl; Caffeine Citrate; Vancomycin



Possible Inomax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-05

Patient: female

Reactions: Device Failure, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax
    Dosage: 60 ppm;cont;inh
    Indication: Hypoxia
    Start date: 2012-01-01
    End date: 2012-02-19

Inomax



Possible Inomax side effects in 52 year old female

Reported by a individual with unspecified qualification from United States on 2012-02-22

Patient: 52 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Device Issue, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Inovent (Delivery System)
    Indication: Acute Respiratory Distress Syndrome

Inomax
    Dosage: 40 ppm, cont. inh
    Indication: Acute Respiratory Distress Syndrome
    Start date: 2012-02-06

Other drugs received by patient: Diprivan



Possible Inomax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-13

Patient: male

Reactions: NO Therapeutic Response

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax



Possible Inomax side effects in 2 month old male

Reported by a individual with unspecified qualification from United States on 2012-02-10

Patient: 2 month old male

Reactions: Oxygen Saturation Decreased

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm;cont;inh 10 ppm;cont;inh 20 ppm;cont;inh
    Indication: Persistent Foetal Circulation
    Start date: 2012-01-12
    End date: 2012-01-22

Inomax
    Dosage: 20 ppm;cont;inh 10 ppm;cont;inh 20 ppm;cont;inh
    Indication: Persistent Foetal Circulation
    Start date: 2012-01-22
    End date: 2012-01-25

Inomax
    Dosage: 20 ppm;cont;inh 10 ppm;cont;inh 20 ppm;cont;inh
    Indication: Persistent Foetal Circulation
    Start date: 2012-01-25

Inomax
    Indication: Persistent Foetal Circulation
    Start date: 2012-01-12

Other drugs received by patient: Albuterol; Curosurf; Epinephrine; Caffeine; Vasopressin and Analogues



Possible Inomax side effects in male

Reported by a physician from United States on 2012-02-03

Patient: male, weighing 0.8 kg (1.8 pounds)

Reactions: Cardiac Murmur, Hypotension, Oliguria, Patent Ductus Arteriosus, Sepsis, Pneumothorax, Acidosis

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Ampicillin; Fentanyl; Ketamine Hydrochloride; Normal-Serum-Albumin (Human); Atropine; Epinephrine; Sodium Bicardbonate; Amplicillin; Furosemide; Fluconazole; Cefotaxime; Vancomycin; Rocuronium Bromide; Caffeine Citrate; Indocin; Versed



Possible Inomax side effects in 13 year old female

Reported by a physician from United States on 2012-02-02

Patient: 13 year old female

Reactions: Insulin Resistance, Hyperthermia Malignant, Lung Abscess

Adverse event resulted in: death

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Antibiotics



Possible Inomax side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-30

Patient: 44 year old female

Reactions: Device Failure, Cardio-Respiratory Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Inomax Dsir (Delivery System)

Inomax
    Dosage: 20 ppm;cont;inh
    Indication: Hypoxia
    Start date: 2012-01-13
    End date: 2012-01-15



Possible Inomax side effects in 4 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-26

Patient: 4 month old male

Reactions: Bradycardia, Device Malfunction, Oxygen Saturation Decreased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Epinephrine; Fentanyl Citrate; Milrinone; Dopamine HCL; Sodium Bicarbonate; Lung Surfactants; Vancomycin



Possible Inomax side effects in

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-22

Patient:

Reactions: Pneumothorax, Cardio-Respiratory Arrest Neonatal, Blood Pressure Decreased, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm;cont;inh, 20 ppm;cont;inh
    Indication: Pulmonary Hypertension
    Start date: 2011-12-14
    End date: 2011-12-14

Inomax
    Dosage: 20 ppm;cont;inh, 20 ppm;cont;inh
    Indication: Pulmonary Hypertension
    Start date: 2011-12-14

Other drugs received by patient: Dopamine HCL; Lung Surfactants; Sodium Chloride; Epinephrine



Possible Inomax side effects in male

Reported by a individual with unspecified qualification from Puerto Rico on 2011-12-20

Patient: male

Reactions: Pulmonary Hypertension, Cardio-Respiratory Arrest, Sepsis Neonatal, Endocarditis, Acidosis, Staphylococcus Test Positive

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Inomax
    Dosage: 20 ppm;cont;inh, 20 ppm;cont;inh
    Indication: Pulmonary Hypertension
    Start date: 2011-10-13
    End date: 2011-10-25

Inomax
    Dosage: 20 ppm;cont;inh, 20 ppm;cont;inh
    Indication: Pulmonary Hypertension
    Start date: 2011-10-25
    End date: 2011-10-27

Other drugs received by patient: Dobutamine HCL; Gentamicin; Ampicillin; Vancomycin Hychloride; Ceftin; Dopamine HCL; Antifungals



Possible Inomax side effects in 7 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-16

Patient: 7 month old male

Reactions: Bradycardia, Device Malfunction, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Inomax

Other drugs received by patient: Levalbuterol Hydrochloride; Budesonide; Ipratropium Bromide

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