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Flomax (Tamsulosin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Flomax (Tamsulosin) 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 (143)
Death (13)
Life Threatening Events (2)
Disability (13)

Reports by Reaction Type

Dizziness (24)Anxiety (15)Insomnia (15)Drug Ineffective (14)Rash (14)Arthralgia (14)Sexual Dysfunction (14)Hypertension (14)Pain (13)Fatigue (13)Neuropathy Peripheral (13)Oedema Peripheral (13)

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

Possible Flomax side effects in male

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

Patient: male

Reactions: Fatigue, Hypotension, Dizziness

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Cozaar; Cordarone; Toprol-XL



Possible Flomax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Flomax



Possible Flomax side effects in male

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

Patient: male

Reactions: Dysuria

Drug(s) suspected as cause:
Flomax



Possible Flomax side effects in 81 year old male

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

Patient: 81 year old male

Reactions: Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flomax



Possible Flomax side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 52 year old male, weighing 94.3 kg (207.5 pounds)

Reactions: Abdominal Pain, Blood Urine Present, Wrong Technique in Drug Usage Process, Hypersensitivity, LIP Disorder, Drug Ineffective, Urinary Tract Infection, Erectile Dysfunction, Somnolence, Neuropathy Peripheral, Prostatomegaly

Drug(s) suspected as cause:
Alcohol
    Dosage: unk

Flomax
    Dosage: 0.4 mg, daily
    Indication: Prostatomegaly

Gabapentin
    Dosage: unk
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01

Intelence
    Dosage: 100 mg, 4x/day
    Indication: HIV Infection

Intelence
    Dosage: 200 mg, 2x/day

Isentress
    Dosage: 400 mg, 2x/day
    Indication: HIV Infection

Norvir
    Dosage: unk
    Indication: HIV Infection
    End date: 2007-01-01

Tramadol HCL
    Dosage: 50 mg, unk
    Indication: Migraine

Vicodin
    Dosage: unk
    Indication: Pain in Extremity

Vicodin
    Indication: Back Pain

Other drugs received by patient: Ibuprofen



Possible Flomax side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Blood Cholesterol Abnormal, Dyspnoea, Increased Upper Airway Secretion, Upper-Airway Cough Syndrome

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Dysuria
    Start date: 2005-01-01

Spiriva
    Indication: Dyspnoea

Spiriva
    Dosage: 18 mg
    Indication: Oedema
    Start date: 2012-04-01

Other drugs received by patient: Medication NOT Further Specified; Avodart



Possible Flomax side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Dizziness, Urinary Retention, Cold Sweat, Urine Output Increased, Lethargy

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Start date: 2012-08-13
    End date: 2012-08-13

Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Nephrolithiasis
    Start date: 2012-04-01
    End date: 2012-04-01

Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Urinary Retention
    Start date: 2012-06-12
    End date: 2012-06-12

Other drugs received by patient: Percocet; Motrin; Cozaar



Possible Flomax side effects in 80 year old male

Reported by a physician from United States on 2012-08-17

Patient: 80 year old male

Reactions: Muscular Weakness

Drug(s) suspected as cause:
Flomax



Possible Flomax side effects in male

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

Patient: male, weighing 120.7 kg (265.4 pounds)

Reactions: Ejaculation Failure, Dizziness, Erectile Dysfunction, Loss of Libido

Drug(s) suspected as cause:
Finasteride
    Dosage: 1 daily
    Indication: Pollakiuria

Flomax
    Dosage: 1 daily
    Indication: Pollakiuria



Possible Flomax side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Blood Cholesterol Abnormal, Increased Upper Airway Secretion, Dyspnoea, Upper-Airway Cough Syndrome

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Dysuria
    Start date: 2005-01-01

Spiriva
    Indication: Dyspnoea

Spiriva
    Dosage: 18 mg
    Indication: Oedema
    Start date: 2012-04-01

Other drugs received by patient: Avodart; Medication NOT Further Specified



Possible Flomax side effects in male

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

Patient: male

Reactions: Dizziness Postural, Arthritis

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Prostatic Disorder
    Start date: 2009-01-01

Micardis
    Dosage: 40 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-01



Possible Flomax side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male

Reactions: Psychotic Disorder

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Indication: Prostate Infection
    Start date: 2012-07-01
    End date: 2012-07-01

Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-07-01
    End date: 2012-07-01

Tradjenta
    Dosage: 5 mg
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Flomax side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male

Reactions: Presyncope, Diverticulitis, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apixaban
    Administration route: Oral
    Indication: Embolism
    Start date: 2011-05-19

Coreg
    Dosage: 6.25 mg
    Administration route: Oral
    Indication: Cardiac Disorder
    Start date: 2005-01-01

Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-02-17

Placebo
    Administration route: Oral
    Indication: Embolism
    Start date: 2011-05-19

Other drugs received by patient: Omeprazole; Gabapentin; Furosemide; Aspirin; Baclofen; Rosuvastatin; Quinapril; Magnesium Hydroxide TAB; Augmentin '500'



Possible Flomax side effects in male

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

Patient: male

Reactions: Haematuria, Urinary Tract Infection, Urine Flow Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Indication: Urine Flow Decreased
    Start date: 2011-01-01

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2008-01-01

Other drugs received by patient: Levothyroxine Sodium; Ventolin HFA; Bumetanide; Foradil; Diovan; Nitroglycerin; Simethicone; Metoprolol Tartrate; Aspirin; Albuterol; Coumadin; Glimepiride; Lipitor; Omeprazole



Possible Flomax side effects in male

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

Patient: male

Reactions: Neuropathy Peripheral, Intermittent Claudication, Pollakiuria, Micturition Urgency

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Hydrochlorothiazide; Losartan Potassium



Possible Flomax side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-25

Patient: 75 year old male

Reactions: Fatigue, Muscle Atrophy

Drug(s) suspected as cause:
Avodart
    Indication: Product Used FOR Unknown Indication

Flomax
    Indication: Product Used FOR Unknown Indication



Possible Flomax side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Panic Attack

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Flomax
    Dosage: 4 mg, one a night, po
    Administration route: Oral
    Indication: Prostatomegaly
    Start date: 2012-06-12
    End date: 2012-06-19

Flomax
    Dosage: 4 mg, one a night, po
    Administration route: Oral
    Indication: Urinary Retention
    Start date: 2012-06-12
    End date: 2012-06-19



Possible Flomax side effects in male

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

Patient: male

Reactions: Productive Cough, Lymphadenopathy, Prostatitis, Diabetes Mellitus, Oropharyngeal Pain, Oedema Peripheral, Cervical Spinal Stenosis, Intervertebral Disc Displacement, Renal Aneurysm, Nervousness, Back Pain, Haematuria, Pancytopenia, Bursitis, Osteopenia, Meniere's Disease, Hypogonadism, Ocular Hyperaemia, Left Atrial Dilatation, Actinomycosis, Aortic Valve Sclerosis, Multiple Myeloma, Rotator Cuff Syndrome, Malignant Melanoma, Depression, Heterotaxia, Tooth Fracture, Cataract, Paraesthesia Oral, Musculoskeletal Pain, Haemorrhoids, Hypophosphataemia, Arthralgia, Impaired Healing, Sinus Disorder, Metastases To Bone, Hypogammaglobulinaemia, Primary Sequestrum, Sciatica, Osteomyelitis, Pulmonary Embolism, Headache, Tooth Infection, Pyrexia, Transaminases Increased, Pericardial Effusion, Herpes Zoster, Oral Candidiasis, Carpal Tunnel Syndrome, Tendonitis, Dysphagia, Pneumonia, Cardiac Murmur, Gingival Bleeding, Pain in Extremity, Anaemia, Benign Prostatic Hyperplasia, General Physical Health Deterioration, Renal Cyst, Decreased Interest, Paraproteinaemia, Aspartate Aminotransferase Increased, Insomnia, Confusional State, Mouth Ulceration, Pain, Tonsillitis, Myelodysplastic Syndrome, Oral Herpes, Hypokalaemia, Myalgia, Nephrolithiasis, Fatigue, Neuropathy Peripheral, Dyspnoea Exertional, Bone Loss, Beta Haemolytic Streptococcal Infection, RED Blood Cell Count Decreased, Dizziness, Intervertebral Disc Degeneration, Thrombocytopenia, RIB Fracture, Pain in JAW, Scleritis, Dental Caries, Psoriasis, Hyponatraemia, Musculoskeletal Chest Pain, Rash, Facial Pain, Lower Extremity Mass, Anxiety, Osteoarthritis, Haemoglobin Decreased, Gingival Recession, Osteonecrosis of JAW, Sexual Dysfunction, Leukocytosis, Hypertension, Gastrointestinal Tract Irritation

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Aredia
    Dosage: unk ukn, qw4
    Start date: 2002-01-01
    End date: 2002-12-01

Flomax

Zometa
    Dosage: unk ukn, qmo
    Start date: 2003-01-01
    End date: 2004-12-01

Other drugs received by patient: Chemotherapeutics NOS; Levaquin; Tylenol; Senokot; Solu-Medrol; Vicodin; Amitriptyline Hydrochloride; Colchicine; Elavil; Famvir / UNK /; Lasix; Baclofen; Diflucan; Gabapentin; Cleocin Hydrochloride; Flexeril; Procardia; Oxycodone HCL; Ambien; Magic Mouthwash; Uroxatral; Flector 13%; Doxycycline; SAW Palmetto; Vitamin A; Zofran; Nystatin; Augmentin '125'; Protonix; Vancomycin; Dexamethasone; Cyclophosphamide; Testosterone; Multi-Vitamins; Zosyn; Acyclovir; Motrin; Revlimid; Ditropan; Zoloft; Beclomethasone Aqueous; Allopurinol; Chlorhexidine Gluconate; Tetracycline; Ranestol; Valium; Dilaudid; Omeprazole



Possible Flomax side effects in male

Reported by a consumer/non-health professional from Canada on 2012-07-23

Patient: male

Reactions: Therapeutic Response Unexpected

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Atacand; Norvasc



Possible Flomax side effects in male

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

Patient: male, weighing 97.7 kg (214.9 pounds)

Reactions: Flatulence

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Fenofibrate; Lisinopril; Simvastatin



Possible Flomax side effects in 87 year old male

Reported by a physician from Japan on 2012-07-19

Patient: 87 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Drug-Induced Liver Injury

Drug(s) suspected as cause:
Flomax
    Administration route: Oral
    Start date: 2012-03-20
    End date: 2012-03-22

Omeprazole
    Administration route: Oral
    Start date: 2012-04-02
    End date: 2012-04-05

Rocephin
    Start date: 2012-03-20
    End date: 2012-03-20

TPN Electrolytes IN Plastic Container
    Start date: 2012-04-02
    End date: 2012-04-05



Possible Flomax side effects in male

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

Patient: male

Reactions: Cataract, Micturition Urgency, Muscle Spasms

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Avodart; EYE Drops



Possible Flomax side effects in male

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

Patient: male

Reactions: Incorrect Route of Drug Administration, Atrial Flutter

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Prostatic Disorder
    Start date: 2008-01-01

Spiriva
    Dosage: 18 mcg
    Administration route: Oral
    Start date: 2012-07-06
    End date: 2012-07-06

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2008-01-01

Other drugs received by patient: Lipitor; Vesicare; Quinapril; Phenazopyridine HCL TAB; Tramadol HCL; Aleve; Aspirin; Proventil



Possible Flomax side effects in male

Reported by a physician from Canada on 2012-07-17

Patient: male

Reactions: Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Norvasc; Atacand; Lipitor



Possible Flomax side effects in male

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

Patient: male

Reactions: Eye Discharge, Rhinorrhoea

Drug(s) suspected as cause:
Flomax

Other drugs received by patient: Baclofen



Possible Flomax side effects in male

Reported by a physician from Japan on 2012-07-16

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Drug-Induced Liver Injury

Drug(s) suspected as cause:
Flomax
    Administration route: Oral
    Start date: 2012-03-20
    End date: 2012-03-22

Omeprazole
    Administration route: Oral
    Start date: 2012-04-02
    End date: 2012-04-05

Rocephin
    Start date: 2012-03-20
    End date: 2012-03-20

TPN Electrolytes IN Plastic Container
    Start date: 2012-04-02
    End date: 2012-04-05



Possible Flomax side effects in female

Reported by a physician from Japan on 2012-07-12

Patient: female, weighing 43.9 kg (96.6 pounds)

Reactions: Encephalitis, Encephalopathy, Mycoplasma Infection, Adverse Reaction, Logorrhoea, Euphoric Mood, Communication Disorder, Psychiatric Symptom, Insomnia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambroxol Hydrochloride
    Indication: Bronchitis
    Start date: 2012-03-05
    End date: 2012-03-21

Brocin
    Indication: Bronchitis
    Start date: 2012-03-05
    End date: 2012-03-21

Clarithromycin
    Indication: Bronchitis

Flomax
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-05
    End date: 2012-03-21

Huscode TAB
    Indication: Nasopharyngitis

Huscode TAB
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2012-03-05
    End date: 2012-03-21

Minocycline Hydrochloride
    Indication: Bronchitis
    Start date: 2012-03-12
    End date: 2012-03-16

Neomallermin
    Indication: Bronchitis
    Start date: 2012-03-05
    End date: 2012-03-21

Pranoprofen
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2012-03-05
    End date: 2012-03-21



Possible Flomax side effects in 85 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-11

Patient: 85 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Vomiting, Hepatitis Fulminant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flomax
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-02-20

Maxipime
    Dosage: route:iv
    Indication: Pneumonia
    Start date: 2011-02-18
    End date: 2011-02-21

Other drugs received by patient: Warfarin Sodium; LAC-B; Flomox; Adalat; Anplag; Magnesium Oxide; Anplag; Aspirin; Sepamit



Possible Flomax side effects in male

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

Patient: male

Reactions: Initial Insomnia, Sexual Dysfunction

Drug(s) suspected as cause:
Flomax
    Administration route: Oral

Nuvigil
    Dosage: qam
    Administration route: Oral
    Indication: Sleep Apnoea Syndrome



Possible Flomax side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 64 year old male

Reactions: Heart Rate Increased

Drug(s) suspected as cause:
Flomax

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