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Tyvaso (Treprostinil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tyvaso (Treprostinil) 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 (1214)
Death (286)
Life Threatening Events (4)
Disability (3)

Reports by Reaction Type

Dyspnoea (148)Death (133)Pneumonia (83)Pulmonary Arterial Hypertension (68)Cardiac Failure Congestive (55)Fluid Retention (51)Syncope (50)Pulmonary Hypertension (45)Chest Pain (40)Dizziness (36)Hypotension (33)Fluid Overload (32)

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

Possible Tyvaso side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Unevaluable Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2011-03-22

Tyvaso
    Dosage: unk
    Indication: COR Pulmonale Chronic
    Start date: 2009-11-06



Possible Tyvaso side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Diplopia, Surgery, Vision Blurred, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-06-11

Letairis
    Indication: Mixed Connective Tissue Disease

Tyvaso



Possible Tyvaso side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Dyspnoea, Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2011-09-12
    End date: 2012-07-03

Tyvaso
    Dosage: unk
    Indication: Portal Hypertension
    Start date: 2012-06-12

Other drugs received by patient: Coumadin



Possible Tyvaso side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Dyspnoea, Fluid Retention, Cardiac Failure Congestive

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-02-02

Tyvaso



Possible Tyvaso side effects in 59 year old male

Reported by a physician from United States on 2012-08-10

Patient: 59 year old male, weighing 126.0 kg (277.2 pounds)

Reactions: Dyspnoea

Adverse event resulted in: death

Drug(s) suspected as cause:
Tyvaso
    Dosage: 18-54 mcg (4 in 1 d), inhalation
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-06-27

Tyvaso
    Dosage: 18-54 mcg (4 in 1 d), inhalation
    Indication: COR Pulmonale Chronic
    Start date: 2012-06-27

Tyvaso
    Dosage: 18-54 mcg (4 in 1 d), inhalation
    Indication: PH Body Fluid
    Start date: 2012-06-27

Tyvaso

Other drugs received by patient: Oxygen (Oxygen); Lisinopril; Viagra; Tracleer; Revatio; Aspirin; Spiriva



Possible Tyvaso side effects in 73 year old female

Reported by a physician from United States on 2012-08-10

Patient: 73 year old female

Reactions: Dyspnoea, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Diovan HCT (CO-Diovan); Reglan; Prevacid; Tracleer; Covera-HS; Centrum Silver (Centrum Silver / 01292501 / ); Revatio; Calcium



Possible Tyvaso side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 75 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin
    Dosage: subcutaneous
    Indication: COR Pulmonale Chronic

Tyvaso
    Dosage: 18-54 micrograms (4 in 1 d), inhalation
    Indication: COR Pulmonale Chronic
    Start date: 2012-07-18

Other drugs received by patient: Coumadin; Letairis



Possible Tyvaso side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 81 year old female, weighing 60.9 kg (134.0 pounds)

Reactions: Renal Disorder, Respiratory Failure, Oedema Peripheral, Wound, Hypotension, Cardiac Failure Congestive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Tracleer



Possible Tyvaso side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 65 year old male, weighing 74.5 kg (164.0 pounds)

Reactions: Disease Complication, Fatigue, Oedema Peripheral, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Temazepam (Temazepam) (Capsule); Lasix; Cyclobenzaprine (Cyclobenzaprine) (Tablet); Oxygen (Oxygen); Carvedilol (Carvedilol) (Tablet); Digoxin; Duloxetine Hydrochloride; Requip (Ropinirole Hydrochloride) (Tablet); Spiriva; Ducosate Calcium (Docusate Calcium); Duoneb; Coumadin; Zocor; Albuterol



Possible Tyvaso side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 65 year old male, weighing 74.5 kg (164.0 pounds)

Reactions: Disease Complication, Oedema Peripheral, Headache, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Duonesb (Combivent); Zocor; Carvedilol; Cyclobenzaprine; Digoxin; Coumadin; Cymbala (Duloxetine Hydrochloride); Temazepam; Albuterol; Oxygen (Oxygen); Requip; Spiriva; Lasix; Ducosate Calcium (Ducosate Calcium)



Possible Tyvaso side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 70 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Right Ventricular Failure, Ventilation Perfusion Mismatch, Condition Aggravated, Chronic Obstructive Pulmonary Disease, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revatio

Tyvaso
    Dosage: 18 mcg, inhalation
    Indication: Pulmonary Hypertension
    Start date: 2012-04-18
    End date: 2012-04-19

Other drugs received by patient: Letairis; Viagra



Possible Tyvaso side effects in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 66 year old male

Reactions: Speech Disorder, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis (Ambrisentan) (Tablet) (Ambrisentan)
    Dosage: (10 mg), oral
    Administration route: Oral

Tyvaso
    Dosage: inhalation



Possible Tyvaso side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 73 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Tyvaso
    Dosage: 18-54 mcg (4 in 1 d),inhalation
    Indication: Pulmonary Hypertension
    Start date: 2012-05-01

Other drugs received by patient: Adcirca



Possible Tyvaso side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 84 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tyvaso



Possible Tyvaso side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 77 year old female, weighing 55.9 kg (123.0 pounds)

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tyvaso
    Dosage: 216 mcg (54 mcg,4 in 1 d),inhalation
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-05

Tyvaso
    Dosage: 216 mcg (54 mcg,4 in 1 d),inhalation
    Indication: COR Pulmonale Chronic
    Start date: 2012-04-05

Other drugs received by patient: Adcirca; Tracleer; Nifedipine



Possible Tyvaso side effects in 63 year old female

Reported by a physician from United States on 2012-08-03

Patient: 63 year old female, weighing 56.4 kg (124.1 pounds)

Reactions: Pain in Extremity, Impaired Healing, Oedema Peripheral, Pain, Open Wound, Wound Secretion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tyvaso
    Dosage: 18-54 may. (4 in 1 d),inhalation
    Indication: Pulmonary Hypertension
    Start date: 2011-11-09

Tyvaso

Other drugs received by patient: Aspirin



Possible Tyvaso side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 81 year old female, weighing 61.4 kg (135.0 pounds)

Reactions: Activities of Daily Living Impaired, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

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

Tyvaso
    Dosage: 18 to 54 mcgs (4 in 1 d), inhalation
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-06-26
    End date: 2012-07-01

Other drugs received by patient: Revatio; Coumadin (Warfairn Sodium)



Possible Tyvaso side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Therapy Cessation

Adverse event resulted in: death

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Letairis; Coumadin; Revatio



Possible Tyvaso side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Chills, Stent Placement, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2008-10-21
    End date: 2012-07-18

Tyvaso
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Revatio



Possible Tyvaso side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: male, weighing 63.2 kg (139.0 pounds)

Reactions: Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revatio
    Indication: Product Used FOR Unknown Indication

Tyvaso
    Dosage: 54 ug, 4x/day (daily dose 216 ug)
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-10-04

Other drugs received by patient: Coumadin; Ambrisentan



Possible Tyvaso side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male, weighing 89.8 kg (197.6 pounds)

Reactions: Dyspnoea, Ventilation Perfusion Mismatch, Drug Intolerance, Hypoxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-03-29

Letairis
    Indication: Chronic Obstructive Pulmonary Disease

Revatio
    Dosage: unk

Tyvaso
    Dosage: unk
    Start date: 2012-03-28



Possible Tyvaso side effects in 65 year old male

Reported by a physician from United States on 2012-07-31

Patient: 65 year old male, weighing 74.5 kg (164.0 pounds)

Reactions: Dyspnoea, Oedema Peripheral, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Coumadin



Possible Tyvaso side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 63 year old male, weighing 69.1 kg (152.0 pounds)

Reactions: RED Blood Cell Count Decreased, Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Tracleer; Coumadin; Revatio



Possible Tyvaso side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 56 year old female

Reactions: Dyspnoea, Pneumonia, Haemorrhage, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Tracleer; Coumadin



Possible Tyvaso side effects in 83 year old female

Reported by a physician from United States on 2012-07-31

Patient: 83 year old female, weighing 65.9 kg (145.0 pounds)

Reactions: Hyponatraemia, Pulmonary Arterial Hypertension, Blood Magnesium Decreased, Malaise, Oedema Peripheral, Asthenia, Cardiac Failure Congestive, Cough, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Coumadin



Possible Tyvaso side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: male

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-08-01
    End date: 2012-06-22

Tyvaso
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-12-14

Other drugs received by patient: Coumadin



Possible Tyvaso side effects in 76 year old male

Reported by a physician from United States on 2012-07-26

Patient: 76 year old male, weighing 119.5 kg (262.9 pounds)

Reactions: Dyspnoea, Fatigue, Laboratory Test Abnormal, Pain in Extremity, Gout, Oedema Peripheral, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Adcirca



Possible Tyvaso side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male

Reactions: Speech Disorder, Chest Discomfort, Throat Irritation, Feeling Abnormal, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tyvaso



Possible Tyvaso side effects in 80 year old female

Reported by a physician from United States on 2012-07-26

Patient: 80 year old female

Reactions: Dyspnoea, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tyvaso

Other drugs received by patient: Adcirca; Letairis



Possible Tyvaso side effects in 59 year old male

Reported by a physician from United States on 2012-07-26

Patient: 59 year old male, weighing 126.0 kg (277.2 pounds)

Reactions: Dyspnoea

Adverse event resulted in: death

Drug(s) suspected as cause:
Tyvaso
    Indication: PH Body Fluid

Tyvaso
    Dosage: 18-54 mcg (4 in 1 d), inhalation
    Indication: COR Pulmonale Chronic
    Start date: 2012-06-27

Other drugs received by patient: Lisinopril; Viagra; Tracleer; Aspirin; Oxygen (Oxygen); Revatio; Spiriva

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