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Remodulin (Treprostinil Subcutaneous) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Remodulin (Treprostinil Subcutaneous) 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 (392)
Death (179)
Life Threatening Events (2)

Reports by Reaction Type

Death (93)Dyspnoea (33)Infusion Site Infection (23)Nausea (23)Vomiting (22)Pain in Extremity (20)Headache (19)Pyrexia (18)Diarrhoea (18)Pulmonary Arterial Hypertension (17)Hypotension (17)Sepsis (15)

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

Possible Remodulin side effects in 5 year old female

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

Patient: 5 year old female

Reactions: Vomiting, Pulmonary Arterial Hypertension, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-06-30

Other drugs received by patient: Sildenafil



Possible Remodulin side effects in 71 year old female

Reported by a physician from United States on 2012-08-20

Patient: 71 year old female

Reactions: Migraine, Pneumonia, Vomiting, Nausea, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: unk
    Start date: 2012-07-01

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Sildenafil



Possible Remodulin side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female

Reactions: Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-02-16

Remodulin
    Dosage: unk
    Indication: COR Pulmonale Chronic
    Start date: 2012-02-03

Other drugs received by patient: Tracleer



Possible Remodulin side effects in 62 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 62 year old female

Reactions: Dyspnoea, Vomiting, Nausea, Anaemia, Gastric Haemorrhage, Haemoglobin Decreased, Haematocrit Decreased, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 28 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-03-29

Remodulin

Other drugs received by patient: Diuretics; Adcirca



Possible Remodulin 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 Remodulin side effects in 53 year old female

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

Patient: 53 year old female, weighing 70.1 kg (154.3 pounds)

Reactions: Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 46 year old female

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

Patient: 46 year old female, weighing 97.7 kg (214.9 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 35 year old female

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

Patient: 35 year old female, weighing 84.8 kg (186.6 pounds)

Reactions: Pulmonary Hypertension, Dyspnoea, Vomiting, Condition Aggravated, Sepsis, Infusion Site Cellulitis, Infusion Site Induration, Infusion Site Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Revatio; Coumadin; Digoxin; Tracleer; Benadryl; Hydroxyzine



Possible Remodulin side effects in 54 year old female

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

Patient: 54 year old female, weighing 54.5 kg (119.8 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 54 year old female

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

Patient: 54 year old female, weighing 118.0 kg (259.6 pounds)

Reactions: Confusional State, Mental Status Changes, Device Alarm Issue, Disorientation, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 71 year old female

Reported by a physician from United States on 2012-08-06

Patient: 71 year old female

Reactions: Migraine, Pneumonia, Vomiting, Nausea, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Sildenafil



Possible Remodulin side effects in 67 year old male

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

Patient: 67 year old male, weighing 86.4 kg (190.0 pounds)

Reactions: Respiratory Disorder, Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: 2.88 ug/kg (0.002 ug/kg, 1 in 1 min), subcutaneous
    Indication: Pulmonary Hypertension
    Start date: 2012-07-10

Remodulin
    Dosage: 2.88 ug/kg (0.002 ug/kg, 1 in 1 min), subcutaneous
    Indication: COR Pulmonale Chronic
    Start date: 2012-07-10

Remodulin
    Dosage: 2.88 ug/kg (0.002 ug/kg, 1 in 1 min), subcutaneous
    Indication: Pulmonary Hypertension
    Start date: 2012-06-28

Remodulin
    Dosage: 2.88 ug/kg (0.002 ug/kg, 1 in 1 min), subcutaneous
    Indication: COR Pulmonale Chronic
    Start date: 2012-06-28

Other drugs received by patient: Adcirca



Possible Remodulin side effects in 75 year old female

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

Patient: 75 year old female, weighing 56.1 kg (123.4 pounds)

Reactions: Hypotension, Gait Disturbance, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: 33.12 ug.jg (0.023 ug.kg, 1 in 1 min), iv drip
    Indication: Pulmonary Hypertension
    Start date: 2012-06-26

Remodulin
    Dosage: 33.12 ug.jg (0.023 ug.kg, 1 in 1 min), iv drip
    Indication: COR Pulmonale Chronic
    Start date: 2012-06-26

Other drugs received by patient: Revatio



Possible Remodulin side effects in 65 year old male

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

Patient: 65 year old male, weighing 119.0 kg (261.8 pounds)

Reactions: Weight Increased, Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Adcirca; Coumadin



Possible Remodulin side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Fall, Subdural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Adcirca; Tracleer



Possible Remodulin side effects in 68 year old female

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

Patient: 68 year old female, weighing 77.2 kg (169.8 pounds)

Reactions: Sepsis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Coumadin



Possible Remodulin side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: 46 year old female

Reactions: Subdural Haemorrhage, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Adcirca; Tracleer



Possible Remodulin side effects in 69 year old female

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

Patient: 69 year old female, weighing 49.5 kg (109.0 pounds)

Reactions: Infusion Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Adcirca; Tracleer



Possible Remodulin side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: 65 year old female

Reactions: Weight Increased, Abdominal Distension, Mobility Decreased, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Renal and Liver Transplant, Pulmonary Hypertension, Cellulitis, Hypotension, Myocardial Strain, Cardiogenic Shock, Renal Failure, Liver Function Test Abnormal, Bacterial Sepsis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Adcirca



Possible Remodulin side effects in 80 year old female

Reported by a physician from Taiwan, Province of China on 2012-07-31

Patient: 80 year old female

Reactions: Pulmonary Arterial Hypertension, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin

Remodulin

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral

Ventavis
    Indication: Pulmonary Arterial Hypertension

Viagra



Possible Remodulin side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: 35 year old female

Reactions: Dyspnoea, Chills, Maternal Exposure During Pregnancy, Chest Pain, Pyrexia, Device Related Infection, Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Furosemide



Possible Remodulin side effects in 76 year old female

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

Patient: 76 year old female, weighing 61.8 kg (136.0 pounds)

Reactions: Dyspnoea, Chronic Obstructive Pulmonary Disease, Fluid Retention

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: 31.68 ug/kg (0.22 ug/kg, 1 in 1 min)
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-12-06

Revatio
    Dosage: unk



Possible Remodulin side effects in female

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

Patient: female

Reactions: Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-02-16

Remodulin
    Dosage: unk
    Indication: COR Pulmonale Chronic
    Start date: 2012-02-03

Other drugs received by patient: Tracleer



Possible Remodulin side effects in 67 year old male

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

Patient: 67 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Oxygen Saturation Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Tracleer; Revatio; Aspirin



Possible Remodulin side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 77 year old female, weighing 49.1 kg (108.0 pounds)

Reactions: Pulmonary Hypertension, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin

Other drugs received by patient: Revatio



Possible Remodulin side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 77 year old male, weighing 67.3 kg (148.0 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin



Possible Remodulin side effects in 62 year old female

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

Patient: 62 year old female, weighing 94.1 kg (207.0 pounds)

Reactions: Infusion Site Infection, Infusion Site Pain, Infusion Site Swelling, Infusion Site Pruritus, Infusion Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: see image
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-07-06

Remodulin
    Dosage: see image
    Indication: Pulmonary Hypertension
    Start date: 2011-07-06

Remodulin
    Dosage: see image
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-07-10

Remodulin
    Dosage: see image
    Indication: Pulmonary Hypertension
    Start date: 2012-07-10

Remodulin
    Dosage: see image
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-06-23

Remodulin
    Dosage: see image
    Indication: Pulmonary Hypertension
    Start date: 2011-06-23

Other drugs received by patient: Coumadin; Revatio; Metoprolol Tartrate



Possible Remodulin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female, weighing 22.7 kg (50.0 pounds)

Reactions: Colostomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin
    Dosage: 109.44 ug/kg, (0.076 ng/kg/min)
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-05-01

Revatio

Other drugs received by patient: Acetylsalicylic Acid



Possible Remodulin side effects in

Reported by a pharmacist from United States on 2012-07-18

Patient:

Reactions: Drug Dose Omission, Catheter Site Swelling, Catheter Site Discharge, Catheter Site Erythema, Catheter Site Infection, Catheter Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-08-16

Other drugs received by patient: Revatio; Coumadin

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