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 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 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 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 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 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 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 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 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 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 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 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 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 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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