Inomax (Nitric Oxide Inhalation) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Controlled studies have included 325 patients on INOmax doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on INOmax, a result adequate to exclude INOmax mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in INOmax and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOmax and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

The table below shows adverse events with an incidence of at least 5% on INOmax in the CINRGI study, and that were more common on INOmax than on placebo.

ADVERSE EVENTS IN THE CINRGI TRIAL

Adverse Event	Placebo (n=89)	Inhaled NO (n=97)
Hypotension	9 (10%)	13 (13%)
Withdrawal	9 (10%)	12 (12%)
Atelectasis	8 (9%)	9 (9%)
Hematuria	5 (6%)	8 (8%)
Hyperglycemia	6 (7%)	8 (8%)
Sepsis	2 (2%)	7 (7%)
Infection	3 (3%)	6 (6%)
Stridor	3 (3%)	5 (5%)
Cellulitis	0 (0%)	5 (5%)

REPORTS OF SUSPECTED INOMAX SIDE EFFECTS / ADVERSE REACTIONS

Possible Inomax side effects / adverse reactions in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-08

Patient: 50 year old male

Reactions: Right Ventricular Failure, Pulmonary Hypertension, Cardio-Respiratory Arrest, Hypotension

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Inomax
    Dosage: 20 ppm; ;inh 1 ppm; ;inh 20 ppm; ;inh 40 ppm; ;inh
    Indication: Heart Transplant
    End date: 2011-10-24

Inomax
    Dosage: 20 ppm; ;inh 1 ppm; ;inh 20 ppm; ;inh 40 ppm; ;inh
    Indication: Heart Transplant
    Start date: 2011-10-24

Inomax
    Dosage: 20 ppm; ;inh 1 ppm; ;inh 20 ppm; ;inh 40 ppm; ;inh
    Indication: Heart Transplant
    Start date: 2011-10-22

Inomax
    Dosage: 20 ppm; ;inh 1 ppm; ;inh 20 ppm; ;inh 40 ppm; ;inh
    Indication: Heart Transplant
    Start date: 2011-10-24

Possible Inomax side effects / adverse reactions in 69 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-22

Patient: 69 year old male

Reactions: Cardiac Arrest

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Inomax
    Dosage: 80;40;5 ppm, inh
    Indication: Chronic Left Ventricular Failure
    Start date: 2011-11-02

Inomax
    Dosage: 80;40;5 ppm, inh
    Indication: Chronic Left Ventricular Failure
    End date: 2011-11-06

Inomax
    Dosage: 80;40;5 ppm, inh
    Indication: Chronic Left Ventricular Failure
    Start date: 2011-11-07
    End date: 2011-11-08

Possible Inomax side effects / adverse reactions in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-23

Patient: male

Reactions: Neonatal Hypoxia, Device Misuse, Bronchial Secretion Retention

Suspect drug(s):
Inomax

Inomax
    Dosage: 20 ppm;cont;inh 1 ppm;cont;inh
    Indication: Pulmonary Hypertension
    Start date: 2011-11-10

Inomax
    Dosage: 20 ppm;cont;inh 1 ppm;cont;inh
    Indication: Pulmonary Hypertension
    End date: 2011-11-15

Other drugs received by patient: Dopamine HCL; Morphine