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Adcirca (Tadalafil) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (11)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Adcirca (Tadalafil) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Adcirca side effects in female

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

Patient: female, weighing 113.4 kg (249.4 pounds)

Reactions: Off Label Use, Thrombosis in Device

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Prednisone TAB; Lisinopril; Protonix; Coreg; Ascorbic Acid; Cyanocobalamin; Nephrocaps; Vitamin D; Aspirin; Celexa



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-08-06

Patient: male

Reactions: Off Label Use, Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tracleer



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-07-30

Patient: male

Reactions: Off Label Use, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tracleer



Possible Adcirca side effects in female

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

Patient: female

Reactions: Off Label Use, Death, Respiratory Disorder

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tyvaso



Possible Adcirca side effects in 58 year old female

Reported by a physician from Japan on 2012-06-14

Patient: 58 year old female

Reactions: Off Label Use, Left Ventricular Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-02-21
    End date: 2012-02-24

Adcirca
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Beraprost Sodium; Eplerenone; Lasix; Hokunalin; Amoxapine; Mendon; Brocin-Codeine; Selbex; Depas; Warfarin Potassium; Ludiomil / SCH /



Possible Adcirca side effects in 58 year old female

Reported by a physician from Japan on 2012-06-05

Patient: 58 year old female

Reactions: Off Label Use, Left Ventricular Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-02-21
    End date: 2012-02-24

Adcirca
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Lasix; Warfarin Potassium; Depas; Eplerenone; Selbex; Amoxapine; Beraprost Sodium; Ludiomil / SCH /; Mendon



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: female, weighing 44.2 kg (97.2 pounds)

Reactions: Off Label Use, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Flolan; Levocetirizine Dihydrochloride; Spironolactone; Digoxin; Furosemide; Gabapentin; Omeprazole; Sertraline Hydrochloride



Possible Adcirca side effects in 58 year old female

Reported by a physician from Japan on 2012-03-07

Patient: 58 year old female

Reactions: Off Label Use, Right Ventricular Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Eplerenone; Amoxapine; Lasix; Selbex; Warfarin Sodium; Depas; Beraprost Sodium; Mendon; Ludiomil / SCH /



Possible Adcirca side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-03

Patient: male

Reactions: Death, Off Label Use

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Lasix; Coreg; Terazosin HCL



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-01-26

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Off Label Use, Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Volibris; Revatio; Diart; Mucofilin; Omeprazole; Pirfenidone



Possible Adcirca side effects in female

Reported by a physician from Japan on 2011-10-03

Patient: female

Reactions: Off Label Use, Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca
    Dosage: 10 mg, unk
    Administration route: Oral
    Start date: 2011-04-21

Adcirca
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2011-04-18
    End date: 2011-04-20

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