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Rapaflo (Silodosin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rapaflo (Silodosin) 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 (105)
Death (18)
Life Threatening Events (8)
Disability (4)

Reports by Reaction Type

Loss of Consciousness (17)Death (10)Dizziness (9)Syncope (9)Liver Disorder (5)Dyspnoea (5)Sudden Hearing Loss (4)Fall (4)Diarrhoea (4)Tachycardia (3)Orthostatic Hypotension (3)Interstitial Lung Disease (3)

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

Possible Rapaflo side effects in female

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

Patient: female, weighing 56.2 kg (123.7 pounds)

Reactions: Incoherent, Ketosis, Rash Morbilliform, Disorientation, Rash Pruritic

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in 70 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 70 year old male, weighing 117.9 kg (259.5 pounds)

Reactions: Angioedema

Drug(s) suspected as cause:
Rapaflo
    Indication: Nephrolithiasis
    Start date: 2012-08-02
    End date: 2012-08-05

Rapaflo
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-08-02
    End date: 2012-08-05



Possible Rapaflo side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male

Reactions: Interstitial Lung Disease, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Purgatives and Clysters



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a physician from Japan on 2012-08-15

Patient: male

Reactions: Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin
    Dosage: 500 mg daily
    Administration route: Oral
    Indication: Cystitis
    Start date: 2012-02-19
    End date: 2012-02-21

Rapaflo
    Dosage: 4 mg bid
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-02-20

Sulfamethoxazole and Trimethoprim
    Dosage: 4 dosage forms
    Administration route: Oral
    Indication: Cystitis
    Start date: 2012-02-29
    End date: 2012-03-02

Other drugs received by patient: Depas; Amlodipine Besylate; Rize / 00624801 /; Aspirin



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-08-15

Patient: male

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-30
    End date: 2012-06-26

Sulfamethoxazole and Trimethoprim
    Dosage: 1 tab q 2nd day (0.5 dosage forms)
    Administration route: Oral
    Indication: Bronchitis Chronic
    Start date: 2011-04-20

Other drugs received by patient: Adalat; Eviprostat; Sandimmune; Bredinin; Prednisolone; Imuran; Indapamide; Kolantyl / 00130401 /; Aspirin; Aspirin; Povidone Iodine; Povidone Iodine; Urinorm; Bredinin



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-08-09

Patient: male

Reactions: Drug Effect Increased, Dizziness, Headache, Nocturia, Hypertension

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Finasteride



Possible Rapaflo side effects in male

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

Patient: male

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bredinin
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-01

Bredinin
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-01

Imuran
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-01

Imuran
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-01

Rapaflo
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-01

Sandimmune
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2012-01-01

Sandimmune
    Dosage: unk
    End date: 2012-01-01

Other drugs received by patient: Eviprostat



Possible Rapaflo side effects in male

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

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

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

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Jaundice, Balance Disorder, Dizziness, Bilirubin Conjugated Increased

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Prograf; Bactrim; Ursodiol; Cellcept



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-07-24

Patient: male

Reactions: Hypotension, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Phenytoin Sodium; Androcur; Rabeprazole Sodium; Gardenal / 00023201 /; Acarbose; Tegretol-XR; Metformin HCL



Possible Rapaflo side effects in male

Reported by a physician from United States on 2012-07-24

Patient: male, weighing 82.0 kg (180.4 pounds)

Reactions: Syncope, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo
    Dosage: 8 mg, daily
    Administration route: Oral
    Indication: Urinary Retention
    Start date: 2011-09-01

Rapaflo
    Indication: Benign Prostatic Hyperplasia



Possible Rapaflo side effects in male

Reported by a physician from United States on 2012-07-24

Patient: male, weighing 88.0 kg (193.6 pounds)

Reactions: Bladder Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-07-19

Patient: male

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bredinin
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Imuran
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Rapaflo
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-01

Sandimmune
    Dosage: unk
    Indication: Renal Transplant

Other drugs received by patient: Eviprostat



Possible Rapaflo side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: female

Reactions: Off Label Use, Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: male

Reactions: Syncope, Blood Pressure Decreased, Loss of Consciousness

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Italy on 2012-07-17

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Doxazosin Mesylate



Possible Rapaflo side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 52 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a physician from United States on 2012-07-11

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a physician from Japan on 2012-07-11

Patient: male

Reactions: Mouth Haemorrhage, Platelet Count Decreased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Chinese Medicine (Ninjin-Yoei-TO)
    Dosage: 9 g, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-19

Olmesartan Medoxomil
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-06
    End date: 2012-05-19

Rapaflo
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-15
    End date: 2012-05-19

Other drugs received by patient: Lendormin



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Italy on 2012-07-10

Patient: male, weighing 120.0 kg (264.0 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Protaphane; Actrapid / 00646001 /



Possible Rapaflo side effects in male

Reported by a physician from Japan on 2012-07-05

Patient: male

Reactions: Interstitial Lung Disease, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Purgatives and Clysters



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-06-27

Patient: male

Reactions: Mouth Haemorrhage, Platelet Count Decreased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Chinese Medicine (Ninjin-Yoei-TO)
    Dosage: 9 g, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-19

Olmesartan Medoxomil
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01
    End date: 2012-05-19

Rapaflo
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-15
    End date: 2012-05-19

Other drugs received by patient: Lendormin



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Japan on 2012-06-19

Patient: male

Reactions: Interstitial Lung Disease, Loss of Consciousness

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Italy on 2012-06-19

Patient: male, weighing 86.0 kg (189.2 pounds)

Reactions: Dysarthria, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Allopurinol; Atorvastatin



Possible Rapaflo side effects in 75 year old male

Reported by a consumer/non-health professional from Japan on 2012-06-14

Patient: 75 year old male

Reactions: Mouth Haemorrhage, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: male

Reactions: Fall, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Cartia XT



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Italy on 2012-05-30

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from Italy on 2012-05-29

Patient: male, weighing 86.0 kg (189.2 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rapaflo

Other drugs received by patient: Allopurinol; Atorvastatin



Possible Rapaflo side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rapaflo

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