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Letairis (Ambrisentan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Letairis (Ambrisentan) 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 (5393)
Death (1479)
Life Threatening Events (50)
Disability (26)

Reports by Reaction Type

Death (940)Dyspnoea (707)Pneumonia (555)Unevaluable Event (248)Fluid Retention (184)Cardiac Failure Congestive (182)Pulmonary Arterial Hypertension (181)Syncope (171)Chest Pain (150)Fall (135)Oedema (114)Hypotension (114)

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

Possible Letairis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Chills, Pyrexia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-07-02

Letairis
    Indication: Scleroderma

Other drugs received by patient: Tyvaso



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Renal Disorder, Pulmonary Arterial Hypertension

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

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

Patient: female

Reactions: Pneumonia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Indication: Pulmonary Fibrosis

Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-06-16



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Balance Disorder, Vertigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis

Other drugs received by patient: Tyvaso; Adcirca



Possible Letairis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Dyspnoea, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Right Ventricular Failure, Cardio-Respiratory Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis
    Indication: Sleep Apnoea Syndrome

Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-10-04
    End date: 2012-07-01

Other drugs received by patient: Oxygen



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Breast Lump Removal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

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

Patient: female

Reactions: Heart Transplant

Drug(s) suspected as cause:
Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension

Letairis
    Indication: Heart Disease Congenital



Possible Letairis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Pneumonia, Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Indication: Connective Tissue Disorder

Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-05-29



Possible Letairis side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Respiratory Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Catheterisation Cardiac

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Pyrexia, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

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

Patient: female

Reactions: Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Pulmonary Arterial Hypertension, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis

Other drugs received by patient: Tyvaso



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Dyspnoea, Cystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in female

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

Patient: female

Reactions: Localised Infection, Limb Traumatic Amputation

Drug(s) suspected as cause:
Letairis
    Indication: Crest Syndrome

Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2009-04-06

Letairis
    Indication: Scleroderma



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Letairis
    Indication: Scleroderma

Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-04-28
    End date: 2012-07-19



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Fatigue, Stent Placement, Oxygen Saturation Decreased, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis



Possible Letairis side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Interstitial Lung Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Letairis
    Dosage: 2.5mg per day
    Administration route: Oral
    Start date: 2011-05-17
    End date: 2011-05-23

Letairis
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-05-17
    End date: 2011-05-23

Other drugs received by patient: Alfarol; Aldactone; Gasmotin; Mucosta; Calcium Carbonate; Paxil; Alfarol; Sulfamethoxazole and Trimethoprim; Zolpidem; Furosemide; Aspartic Acid; Warfarin Sodium; Neoral; Paxil; Rabeprazole Sodium; Alfarol; Zolpidem; Furosemide; Furosemide; Maglax; Maglax; Gasmotin; Potassium Magnesium Aspartate; Rabeprazole Sodium; Sulfamethoxazole and Trimethoprim; Aldactone; Aspara K; Warfarin Sodium; Warfarin Sodium; Gasmotin; Amoban; Amoban; Neoral; Mucosta; Mucosta; Calcium Carbonate; Fungizone; Fungizone; Sulfamethoxazole and Trimethoprim; Neoral; Calcium Carbonate; Amoban; Aldactone; Cyclosporine; Paxil; Fungizone; Rabeprazole Sodium; Zolpidem; Maglax



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Pneumonia, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Indication: HIV Infection

Letairis
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-07-19



Possible Letairis side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Interstitial Lung Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Letairis
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-05-17
    End date: 2011-05-23

Letairis
    Dosage: 2.5mg per day
    Administration route: Oral
    Start date: 2011-05-17
    End date: 2011-05-23

Other drugs received by patient: Mucosta; Calcium Carbonate; Amoban; Paxil; Zolpidem; Zolpidem; Warfarin Sodium; Sulfamethoxazole and Trimethoprim; Zolpidem; Furosemide; Aspartic Acid; Aspara K; Gasmotin; Mucosta; Mucosta; Calcium Carbonate; Paxil; Fungizone; Furosemide; Cyclosporine; Neoral; Calcium Carbonate; Amoban; Maglax; Warfarin Sodium; Potassium Magnesium Aspartate; Paxil; Fungizone; Alfarol; Alfarol; Aldactone; Furosemide; Maglax; Maglax; Warfarin Sodium; Fungizone; Alfarol; Sulfamethoxazole and Trimethoprim; Aldactone; Neoral; Neoral; Rabeprazole Sodium; Gasmotin; Gasmotin; Amoban; Rabeprazole Sodium; Rabeprazole Sodium; Sulfamethoxazole and Trimethoprim; Aldactone



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Gastrointestinal Haemorrhage, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis

Other drugs received by patient: Tyvaso



Possible Letairis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Fall, Myocardial Infarction, Tremor

Drug(s) suspected as cause:
Letairis

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