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Inomax Side Effects

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Common Inomax Side Effects


The most commonly reported Inomax side effects (click to view or check a box to report):

Oxygen Saturation Decreased (19)
Cardio-respiratory Arrest (17)
Device Failure (12)
Cardiac Arrest (11)
Hypotension (10)
Blood Pressure Decreased (9)
Device Malfunction (8)
Bradycardia (5)
Acute Chest Syndrome (5)
Heart Rate Decreased (5)
Multi-organ Failure (5)
Right Ventricular Failure (5)
Medical Device Complication (4)
Hypoxia (4)
Off Label Use (4)
Pulmonary Embolism (4)
Pulmonary Hypertension (4)
Ventricular Fibrillation (4)
Pulmonary Oedema (3)
Respiratory Failure (3)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Inomax Side Effects Reported to FDA



Inomax Side Effect Report#9498821
Haemoglobin Decreased, Oxygen Saturation Decreased, Platelet Count Decreased, Off Label Use
This is a report of a 47-year-old male patient (weight: NA) from PR, suffering from the following health symptoms/conditions: NA, who was treated with Inomax (nitric Oxide) (dosage: 20 Ppm, Continuous, start time:
Aug 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Haemoglobin Decreased, Oxygen Saturation Decreased, Platelet Count Decreased, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax (nitric Oxide) treatment in male patients, resulting in Haemoglobin Decreased side effect.
Inomax Side Effect Report#9413583
Blood Pressure Decreased, Oxygen Saturation Decreased, Fat Embolism
This report suggests a potential Inomax (nitric Oxide) Blood Pressure Decreased side effect(s) that can have serious consequences. A 19-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: NA and used Inomax (nitric Oxide) (dosage: 5 Ppm; Cont) starting
Dec 18, 2011. After starting Inomax (nitric Oxide) the patient began experiencing various side effects, including: Blood Pressure Decreased, Oxygen Saturation Decreased, Fat EmbolismAdditional drugs used concurrently:
  • Levophed
  • Fentanyl
  • Versed
  • Normal Saline
  • Lactated Ringer^s Injection
  • Sodium Bicarbonate
  • Voluven
  • Zemuron
Although Inomax (nitric Oxide) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Decreased, may still occur.
Inomax Side Effect Report#9380397
Cardiac Arrest, Bradycardia, Device Issue, Cardio-respiratory Arrest
This Cardiac Arrest problem was reported by a health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 13, 2013 this consumer started treatment with Inomax (dosage: 20 Ppm, Continuous, Inhalation). The following drugs were being taken at the same time: NA. When using Inomax, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Bradycardia, Device Issue, Cardio-respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#9283840
Cardiac Arrest, Ventricular Fibrillation, Blood Pressure Decreased, Oxygen Saturation Decreased, Off Label Use, Device Failure, Cardio-respiratory Arrest
This Cardiac Arrest side effect was reported by a health professional from US. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Inomax (drug dosage: 40 Ppm, Continuous, Inhalation), which was initiated on
Apr 23, 2013. Concurrently used drugs: NA..After starting to take Inomax the consumer reported adverse symptoms, such as: Cardiac Arrest, Ventricular Fibrillation, Blood Pressure Decreased, Oxygen Saturation Decreased, Off Label Use, Device Failure, Cardio-respiratory ArrestThese side effects may potentially be related to Inomax.
Inomax Side Effect Report#8928713
Pneumothorax, Heart Rate Decreased, Blood Pressure Decreased, Device Issue
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: vasodilatation,lung disorder, who was treated with Inomax (dosage: 10 Ppm, Continuous, start time: 201211), combined with: NA. and developed a serious reaction and side effect(s): Pneumothorax, Heart Rate Decreased, Blood Pressure Decreased, Device Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in female patients, resulting in Pneumothorax side effect.
Inomax Side Effect Report#8923332
Cardiac Arrest, Device Issue, Haemodynamic Instability
This report suggests a potential Inomax (nitric Oxide) Cardiac Arrest side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: heart valve replacement and used Inomax (nitric Oxide) (dosage: 40 Ppm, Continuous, Inhalation) starting
Oct 29, 2012. After starting Inomax (nitric Oxide) the patient began experiencing various side effects, including: Cardiac Arrest, Device Issue, Haemodynamic InstabilityAdditional drugs used concurrently: NA. Although Inomax (nitric Oxide) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Inomax Side Effect Report#8816494
Hypoxia, Disease Progression
This Hypoxia problem was reported by a consumer or non-health professional from US. A 5-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pulmonary arterial hypertension. On NS this consumer started treatment with Inomax (dosage: NA). The following drugs were being taken at the same time:
  • Busulfan (busulfan)
  • Fludarabine (fludarabine)
  • Cyclophosphamide (cyclophosphamide)
  • Cyclosporine (ciclosporin)
  • Atg /00575401/ (antithymocyte Immunoglobulin)
When using Inomax, the patient experienced the following unwanted symptoms/side effects: Hypoxia, Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoxia, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#8418481-5
Withdrawal Of Life Support
This Withdrawal Of Life Support side effect was reported by a health professional from Canada. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary fibrosis.The patient was prescribed Inomax (drug dosage: 5 Ppm, Continuous, Inhalation), which was initiated on
May 14, 2012. Concurrently used drugs: NA..After starting to take Inomax the consumer reported adverse symptoms, such as: Withdrawal Of Life SupportThese side effects may potentially be related to Inomax.
Inomax Side Effect Report#8415546-9
Ventricular Fibrillation, Cardio-respiratory Arrest
This is a report of a 81-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: pulmonary hypertension,cardiac operation, who was treated with Inomax (dosage: 80 Ppm, Continuous, Inhalation, 60 Ppm, Continuous, Inhalation, start time:
May 15, 2012), combined with: NA. and developed a serious reaction and side effect(s): Ventricular Fibrillation, Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in female patients, resulting in Ventricular Fibrillation side effect. The patient was hospitalized.
Inomax Side Effect Report#8397622-2
Disease Progression
This report suggests a potential Inomax Disease Progression side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hypoxia and used Inomax (dosage: 20 Ppm, Continuous, Inhalation) starting
Mar 08, 2012. After starting Inomax the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Inomax demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Inomax Side Effect Report#8356114-7
Cardio-respiratory Arrest, Respiratory Failure
This Cardio-respiratory Arrest problem was reported by a health professional from United States. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypoxia. On
Apr 28, 2012 this consumer started treatment with Inomax (dosage: 20 Ppm , Continous, Inhalation). The following drugs were being taken at the same time: NA. When using Inomax, the patient experienced the following unwanted symptoms/side effects: Cardio-respiratory Arrest, Respiratory FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardio-respiratory Arrest, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#8353192-6
Oxygen Saturation Decreased, Pulmonary Haemorrhage, Off Label Use
This Oxygen Saturation Decreased side effect was reported by a health professional from United States. A 27-year-old male patient (weight:NA) experienced the following symptoms/conditions: oxygen saturation decreased,acute respiratory distress syndrome.The patient was prescribed Inomax (drug dosage: 20 Ppm, Continuous, Inhalation 40, Inhalation 5, Inhalation), which was initiated on
Apr 20, 2012. Concurrently used drugs: NA..After starting to take Inomax the consumer reported adverse symptoms, such as: Oxygen Saturation Decreased, Pulmonary Haemorrhage, Off Label UseThese side effects may potentially be related to Inomax.
Inomax Side Effect Report#8299466-9
Shock, Brain Oedema, Renal Failure Acute, Off Label Use, Therapeutic Response Decreased, Pulseless Electrical Activity
This is a report of a 59-year-old female patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: oxygen saturation decreased,pulmonary hypertension, who was treated with Inomax (dosage: 40 Ppm; Cont; Inh, start time:
Mar 31, 2012), combined with: NA. and developed a serious reaction and side effect(s): Shock, Brain Oedema, Renal Failure Acute, Off Label Use, Therapeutic Response Decreased, Pulseless Electrical Activity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in female patients, resulting in Shock side effect.
Inomax Side Effect Report#8223395-X
Anoxia
This report suggests a potential Inomax Anoxia side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: cardiopulmonary failure,oxygen saturation decreased and used Inomax (dosage: 20 Ppm;cont;inh) starting
Mar 07, 2012. After starting Inomax the patient began experiencing various side effects, including: AnoxiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Inomax demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anoxia, may still occur.
Inomax Side Effect Report#8117900-1
Lung Abscess, Insulin Resistance, Hyperthermia Malignant
This Lung Abscess problem was reported by a physician from United States. A 13-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ventilation perfusion mismatch. On NS this consumer started treatment with Inomax (dosage: NA). The following drugs were being taken at the same time:
  • Antibiotics
When using Inomax, the patient experienced the following unwanted symptoms/side effects: Lung Abscess, Insulin Resistance, Hyperthermia MalignantAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lung Abscess, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#8106347-X
Device Failure, Cardio-respiratory Arrest
This Device Failure side effect was reported by a health professional from United States. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Inomax Dsir (delivery System) (drug dosage: NA), which was initiated on
Jan 13, 2012. Concurrently used drugs: NA..After starting to take Inomax Dsir (delivery System) the consumer reported adverse symptoms, such as: Device Failure, Cardio-respiratory ArrestThese side effects may potentially be related to Inomax Dsir (delivery System).
Inomax Side Effect Report#7967553-8
Cardio-respiratory Arrest, Pulmonary Malformation, Congenital Bladder Anomaly, Dextrocardia, White Blood Cell Count Increased, Congenital Cystic Kidney Disease
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: oxygen saturation decreased, who was treated with Inomax (dosage: 20 Ppm, Cont, Inh, start time:
Nov 25, 2011), combined with: NA. and developed a serious reaction and side effect(s): Cardio-respiratory Arrest, Pulmonary Malformation, Congenital Bladder Anomaly, Dextrocardia, White Blood Cell Count Increased, Congenital Cystic Kidney Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in male patients, resulting in Cardio-respiratory Arrest side effect.
Inomax Side Effect Report#7941033-8
Cardiac Arrest
This report suggests a potential Inomax Cardiac Arrest side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: chronic left ventricular failure and used Inomax (dosage: 80;40;5 Ppm, Inh) starting
Nov 07, 2011. After starting Inomax the patient began experiencing various side effects, including: Cardiac ArrestAdditional drugs used concurrently: NA. Although Inomax demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Inomax Side Effect Report#7905904-0
Right Ventricular Failure, Hypotension, Pulmonary Hypertension, Cardio-respiratory Arrest
This Right Ventricular Failure problem was reported by a health professional from United States. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: heart transplant. On
Oct 24, 2011 this consumer started treatment with Inomax (dosage: 20 Ppm; ;inh 1 Ppm; ;inh 20 Ppm; ;inh 40 Ppm; ;inh). The following drugs were being taken at the same time: NA. When using Inomax, the patient experienced the following unwanted symptoms/side effects: Right Ventricular Failure, Hypotension, Pulmonary Hypertension, Cardio-respiratory ArrestThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Right Ventricular Failure, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#7535779-3
Haemangioma, Weight Gain Poor, Anaemia, Pulmonary Hypertension, Capillary Disorder, Pulmonary Oedema
This Haemangioma side effect was reported by a physician from United States. A 7-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary arterial hypertension.The patient was prescribed Inomax (drug dosage: 40 Ppm;cont; Nas), which was initiated on NS. Concurrently used drugs:
  • Sildenafil Citrate
.After starting to take Inomax the consumer reported adverse symptoms, such as: Haemangioma, Weight Gain Poor, Anaemia, Pulmonary Hypertension, Capillary Disorder, Pulmonary OedemaThese side effects may potentially be related to Inomax.
Inomax Side Effect Report#7481796-1
Cardio-respiratory Arrest, No Therapeutic Response
This is a report of a 29-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: acute respiratory distress syndrome, who was treated with Inomax (dosage: 40 Ppm;cont;inh, start time:
Feb 13, 2011), combined with: NA. and developed a serious reaction and side effect(s): Cardio-respiratory Arrest, No Therapeutic Response after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in male patients, resulting in Cardio-respiratory Arrest side effect.
Inomax Side Effect Report#7476230-1
Cardiac Arrest, Respiratory Failure
This report suggests a potential Inomax Cardiac Arrest side effect(s) that can have serious consequences. A 32-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: respiratory failure and used Inomax (dosage: 40 Ppm;cont;inh) starting
Apr 16, 2011. After starting Inomax the patient began experiencing various side effects, including: Cardiac Arrest, Respiratory FailureAdditional drugs used concurrently: NA. Although Inomax demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Inomax Side Effect Report#7461640-9
No Therapeutic Response, Cardio-respiratory Arrest
This No Therapeutic Response problem was reported by a health professional from United States. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acute respiratory distress syndrome. On
Feb 13, 2011 this consumer started treatment with Inomax (dosage: 40 Ppm;cont;inh). The following drugs were being taken at the same time: NA. When using Inomax, the patient experienced the following unwanted symptoms/side effects: No Therapeutic Response, Cardio-respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as No Therapeutic Response, may become evident only after a product is in use by the general population.
Inomax Side Effect Report#7421610-3
Oxygen Saturation Decreased, Pericardial Effusion, Bradycardia, Device Malfunction
This Oxygen Saturation Decreased side effect was reported by a health professional from United States. A 4-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary hypertension.The patient was prescribed Inomax (drug dosage: 5 Ppm, Cont; Inh), which was initiated on
Mar 30, 2011. Concurrently used drugs:
  • Inovent (delivery System)
.After starting to take Inomax the consumer reported adverse symptoms, such as: Oxygen Saturation Decreased, Pericardial Effusion, Bradycardia, Device MalfunctionThese side effects may potentially be related to Inomax.
Inomax Side Effect Report#7341522-3
Cardiac Arrest, Ventricular Tachycardia, Hypotension
This is a report of a 29-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: acute respiratory distress syndrome, who was treated with Inomax (dosage: NA, start time:
Feb 09, 2011), combined with:
  • Inovent (delivery System) (20 Ppm;cont;inh ; 50 Ppm;cont;inh ; 60 Ppm;cont;inh ; 64 Ppm;cont;inh)
  • Inovent (delivery System) (20 Ppm;cont;inh ; 50 Ppm;cont;inh ; 60 Ppm;cont;inh ; 64 Ppm;cont;inh)
  • Inovent (delivery System) (20 Ppm;cont;inh ; 50 Ppm;cont;inh ; 60 Ppm;cont;inh ; 64 Ppm;cont;inh)
  • Inovent (delivery System) (20 Ppm;cont;inh ; 50 Ppm;cont;inh ; 60 Ppm;cont;inh ; 64 Ppm;cont;inh)
and developed a serious reaction and side effect(s): Cardiac Arrest, Ventricular Tachycardia, Hypotension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Inomax treatment in male patients, resulting in Cardiac Arrest side effect. The patient was hospitalized.


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The appearance of Inomax on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Inomax reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Inomax Safety Alerts, Active Ingredients, Usage Information

    Inomax Dosage, Warnings, Usage.

    Side Effects reported to FDA: 77

    Inomax safety alerts: 2012 2010

    Reported deaths: 69

    Reported hospitalizations: 21

    Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

    [Posted 01/04/2012]

    AUDIENCE: Pulmonology, Risk Manager

    ISSUE: FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

    Affected serial numbers include DS20070005-DS20100865. This product was manufactured from March 12, 2007 through February 2, 2011 and distributed from September 4, 2007 through February 2, 2011.

    BACKGROUND: INOmax DS Delivery System is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

    RECOMMENDATION: Ikaria implemented a service process change involving the application of DeoxIT, an anti-corrosion lubricant specifically created to prevent fretting corrosion. DeoxIT was added to the preventive maintenance plan for all INOmax DS Drug Delivery Systems and was performed when the Systems rotated through Ikaria’s Regional Service Centers for any routine service activity.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [01/04/2011 - Recall Notice - FDA]

    Related MedWatch Alert:

    [08/23/2010]

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