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Ventavis (Iloprost Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ventavis (Iloprost 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 (1102)
Death (438)
Life Threatening Events (37)
Disability (15)

Reports by Reaction Type

Death (285)Dyspnoea (181)Dizziness (79)Pulmonary Arterial Hypertension (72)Oedema Peripheral (68)Pneumonia (60)Headache (59)Cough (57)Nausea (50)Condition Aggravated (50)Hypotension (48)Fatigue (45)

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

Possible Ventavis side effects in 83 year old male

Reported by a physician from United States on 2012-08-27

Patient: 83 year old male

Reactions: Malaise, Dyspnoea, Oedema Peripheral, Asthenia, Chronic Obstructive Pulmonary Disease, Cardiac Disorder, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension



Possible Ventavis side effects in 73 year old female

Reported by a physician from United States on 2012-08-27

Patient: 73 year old female

Reactions: Dehydration, Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Letairis; Adcirca



Possible Ventavis side effects in 68 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 68 year old female

Reactions: Dyspnoea, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Ventavis



Possible Ventavis side effects in 83 year old female

Reported by a physician from United States on 2012-08-24

Patient: 83 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Hydrocodone Bitartrate; Hydrochlorothiazide; Paregorico; Revatio; Ropinirole; Allopurinol; Demerol



Possible Ventavis side effects in 5 year old female

Reported by a physician from Germany on 2012-08-24

Patient: 5 year old female

Reactions: Dyspnoea, Pulmonary Arterial Hypertension

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Sildenafil



Possible Ventavis side effects in 53 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 53 year old female

Reactions: Lyme Disease

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Coumadin; Sildenafil



Possible Ventavis side effects in 67 year old male

Reported by a physician from United States on 2012-08-24

Patient: 67 year old male

Reactions: Gout

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Aspirin



Possible Ventavis side effects in 63 year old male

Reported by a pharmacist from United States on 2012-08-24

Patient: 63 year old male

Reactions: Spinal Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Aspirin; Sildenafil; Plavix; Tracleer



Possible Ventavis side effects in 33 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 33 year old female

Reactions: Dyspnoea, Subclavian Vein Thrombosis, Fatigue, Palpitations, Chest Pain, Swelling, Vasodilation Procedure, Jugular Vein Thrombosis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Tracleer; Arixtra; Sildenafil



Possible Ventavis side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 56 year old female

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    End date: 2012-07-24

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin; Sildenafil



Possible Ventavis side effects in 61 year old female

Reported by a physician from United States on 2012-08-24

Patient: 61 year old female

Reactions: Abdominal Pain, Vomiting, Retching, Nausea, Rectal Haemorrhage, Condition Aggravated, Mucous Stools, Abdominal Pain Upper, Haematochezia, Abdominal Discomfort, Diarrhoea, Gastrointestinal Disorder, Irritable Bowel Syndrome, Dizziness

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-07-15

Ventavis
    Dosage: unk, x6/day
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-10-31

Ventavis
    Dosage: 5 mcg, unk
    Start date: 2011-11-07
    End date: 2012-07-07

Other drugs received by patient: Aspirin; Vitamin D; Plavix; Celexa; Lovaza



Possible Ventavis side effects in 80 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 80 year old female

Reactions: Arthralgia, Knee Arthroplasty

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin



Possible Ventavis side effects in 87 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 87 year old female

Reactions: International Normalised Ratio Increased, Transfusion, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-08-27

Ventavis
    Dosage: 5 mcg, 6 x daily
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-02-24



Possible Ventavis side effects in 32 year old female

Reported by a physician from Germany on 2012-08-24

Patient: 32 year old female

Reactions: Hospitalisation, Pulmonary Arterial Hypertension, General Physical Health Deterioration, Condition Aggravated, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ilomedin
    Dosage: unk
    Start date: 2010-12-01

Ventavis
    Dosage: 5 ug, unk
    Indication: Pulmonary Hypertension
    Start date: 2010-03-10



Possible Ventavis side effects in 69 year old male

Reported by a physician from Germany on 2012-08-24

Patient: 69 year old male

Reactions: Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Ventavis



Possible Ventavis side effects in 67 year old male

Reported by a physician from United States on 2012-08-24

Patient: 67 year old male

Reactions: Cardiomyopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Sildenafil



Possible Ventavis side effects in 81 year old female

Reported by a physician from United States on 2012-08-22

Patient: 81 year old female

Reactions: Dyspnoea, Urinary Tract Infection, Fatigue, Mitral Valve Incompetence, Oedema Peripheral, Asthenia, Cardiac Failure Congestive, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis
    Dosage: 5 ?g, 6 times daily
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-05-16
    End date: 2012-07-23

Ventavis
    Dosage: unk
    Start date: 2012-04-19
    End date: 2012-05-15

Other drugs received by patient: Allopurinol; Lipitor; Allegra; Pradaxa; Coreg; Iron; Tricor; Calcium; Pepcid; Cozaar; Spironolactone; Lasix; Aspirin; Cardizem



Possible Ventavis side effects in 71 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 71 year old female

Reactions: Breast Cancer, Malignant Breast Lump Removal

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Tracleer; Coumadin



Possible Ventavis side effects in 80 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 80 year old female

Reactions: Cystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Sildenafil



Possible Ventavis side effects in 66 year old male

Reported by a pharmacist from United States on 2012-08-22

Patient: 66 year old male

Reactions: Renal Disorder, Pulmonary Embolism, Musculoskeletal Discomfort, Cyst, Amputation, Fall, Walking AID User, Liver Disorder, Transfusion, Skeletal Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Sildenafil; Coumadin



Possible Ventavis side effects in 84 year old female

Reported by a physician from United States on 2012-08-21

Patient: 84 year old female

Reactions: Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Coumadin



Possible Ventavis side effects in 51 year old female

Reported by a physician from United States on 2012-08-21

Patient: 51 year old female

Reactions: Furuncle

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Tracleer



Possible Ventavis side effects in 63 year old male

Reported by a physician from United States on 2012-08-21

Patient: 63 year old male

Reactions: Atrial Fibrillation, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Adcirca



Possible Ventavis side effects in 41 year old female

Reported by a physician from United States on 2012-08-21

Patient: 41 year old female

Reactions: Vomiting, Diarrhoea, Nausea, Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-08-14

Ventavis
    Dosage: 5 mcg, unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-07-01

Ventavis
    Dosage: 2.5 mcg, unk
    Start date: 2012-06-26



Possible Ventavis side effects in 23 year old male

Reported by a physician from Germany on 2012-08-21

Patient: 23 year old male

Reactions: Renal Impairment, Heart Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Tracleer; Sildenafil



Possible Ventavis side effects in 80 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 80 year old female

Reactions: Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis



Possible Ventavis side effects in 58 year old male

Reported by a physician from United States on 2012-08-21

Patient: 58 year old male

Reactions: Weight Increased, Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis



Possible Ventavis side effects in 53 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 53 year old female

Reactions: Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis



Possible Ventavis side effects in 51 year old male

Reported by a physician from United States on 2012-08-21

Patient: 51 year old male

Reactions: Lung Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

Other drugs received by patient: Adcirca



Possible Ventavis side effects in 72 year old male

Reported by a physician from Germany on 2012-08-21

Patient: 72 year old male

Reactions: Concussion, Contusion, Laceration, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventavis

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