Drug information for JALYN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 0.5MG;0.4MG Prescription  (Reference Drug) DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE dutasteride GLAXOSMITHKLINE 22460
2011-12-20 Other Important Information from FDA

2011-06-13 Letter

2011-06-10 Label

2011-02-03 Review

2011-02-03 Summary Review

2010-06-16 Letter

2010-06-15 Label

2010-03-22 Letter

Drug Adverse Effects information for JALYN

Role code Indications Reaction # Reports
PS BENIGN PROSTATIC HYPERPLASIA ABDOMINAL PAIN 1
PS BENIGN PROSTATIC HYPERPLASIA ANXIETY 1
PS BENIGN PROSTATIC HYPERPLASIA ASTHENIA 1
PS BENIGN PROSTATIC HYPERPLASIA BACK PAIN 2
PS BENIGN PROSTATIC HYPERPLASIA BREAST ENLARGEMENT 1
PS BENIGN PROSTATIC HYPERPLASIA DIZZINESS 1
PS BENIGN PROSTATIC HYPERPLASIA DRUG INEFFECTIVE 1
PS BENIGN PROSTATIC HYPERPLASIA DRUG INTERACTION 1
PS BENIGN PROSTATIC HYPERPLASIA DYSPNOEA 4
PS BENIGN PROSTATIC HYPERPLASIA EAR INFECTION 1
PS BENIGN PROSTATIC HYPERPLASIA EJACULATION DISORDER 1
PS BENIGN PROSTATIC HYPERPLASIA ENURESIS 1
PS BENIGN PROSTATIC HYPERPLASIA GYNAECOMASTIA 1
PS BENIGN PROSTATIC HYPERPLASIA LIBIDO DECREASED 1
PS BENIGN PROSTATIC HYPERPLASIA MUSCLE FATIGUE 1
PS BENIGN PROSTATIC HYPERPLASIA MUSCULAR WEAKNESS 1
PS BENIGN PROSTATIC HYPERPLASIA MYALGIA 1
PS BENIGN PROSTATIC HYPERPLASIA OEDEMA PERIPHERAL 1
PS BENIGN PROSTATIC HYPERPLASIA PAIN IN EXTREMITY 1
PS BENIGN PROSTATIC HYPERPLASIA RESTLESS LEGS SYNDROME 1
PS BENIGN PROSTATIC HYPERPLASIA RETROGRADE EJACULATION 1
PS BENIGN PROSTATIC HYPERPLASIA TESTICULAR PAIN 1
PS BENIGN PROSTATIC HYPERPLASIA URTICARIA 2
PS DYSURIA NOCTURIA 1
PS DYSURIA PRODUCT QUALITY ISSUE 1
PS HYPERTENSION BREAST ENLARGEMENT 1
PS HYPERTENSION DRUG INTERACTION 1
PS HYPERTENSION GYNAECOMASTIA 1
PS NOCTURIA DIARRHOEA 1
PS POLLAKIURIA INFECTION 1
PS POLLAKIURIA TESTICULAR PAIN 1
PS POLLAKIURIA TESTICULAR SWELLING 1
PS PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION BREAST TENDERNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION ERECTILE DYSFUNCTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION GYNAECOMASTIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION INTERNATIONAL NORMALISED RATIO INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION MIGRAINE WITH AURA 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULAR WEAKNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION PAINFUL ERECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 1
PS PROSTATIC DISORDER DRUG INEFFECTIVE 2
PS PROSTATIC DISORDER NOCTURIA 2
PS PROSTATITIS BLOOD GLUCOSE INCREASED 1
PS PROSTATOMEGALY BREAST ENLARGEMENT 2
PS PROSTATOMEGALY BREAST PAIN 1
PS PROSTATOMEGALY BREAST TENDERNESS 1
PS PROSTATOMEGALY DRUG INEFFECTIVE 1
SS BENIGN PROSTATIC HYPERPLASIA BREAST TENDERNESS 1
SS BENIGN PROSTATIC HYPERPLASIA BURNING SENSATION 2
SS BENIGN PROSTATIC HYPERPLASIA FEELING HOT 2
SS BENIGN PROSTATIC HYPERPLASIA GENITAL PAIN 2
SS BENIGN PROSTATIC HYPERPLASIA MYALGIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION BREAST ENLARGEMENT 2
SS PRODUCT USED FOR UNKNOWN INDICATION GYNAECOMASTIA 2
SS PROSTATIC SPECIFIC ANTIGEN INCREASED HYPERHIDROSIS 1
SS PROSTATIC SPECIFIC ANTIGEN INCREASED HYPOTENSION 1
SS PROSTATOMEGALY BLOOD PRESSURE INCREASED 2
SS PROSTATOMEGALY COGNITIVE DISORDER 2
SS PROSTATOMEGALY DISTURBANCE IN ATTENTION 2
SS PROSTATOMEGALY DRUG INEFFECTIVE 2
SS PROSTATOMEGALY FATIGUE 2
SS PROSTATOMEGALY PAIN IN JAW 2
C ASTHMA COUGH 1
C ASTHMA ILL-DEFINED DISORDER 1
C ASTHMA PRODUCT QUALITY ISSUE 1
C ATRIAL FIBRILLATION CEREBRAL HAEMORRHAGE 1
C BENIGN PROSTATIC HYPERPLASIA CEREBRAL HAEMORRHAGE 1
C GASTROOESOPHAGEAL REFLUX DISEASE CEREBRAL HAEMORRHAGE 1
C HIGH DENSITY LIPOPROTEIN DECREASED CAROTID ARTERY OCCLUSION 4
C HIGH DENSITY LIPOPROTEIN DECREASED ERYTHEMA 4
C HIGH DENSITY LIPOPROTEIN DECREASED SKIN BURNING SENSATION 4
C HYPERTENSION CEREBRAL HAEMORRHAGE 3
C MEDICAL DIET CEREBRAL HAEMORRHAGE 5
C NASOPHARYNGITIS ANOSMIA 1
C NASOPHARYNGITIS EXPIRED DRUG ADMINISTERED 1
C POLLAKIURIA CAROTID ARTERY OCCLUSION 2
C POLLAKIURIA ERYTHEMA 2
C POLLAKIURIA SKIN BURNING SENSATION 2
C PRODUCT USED FOR UNKNOWN INDICATION CAROTID ARTERY OCCLUSION 12
C PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA 12
C PRODUCT USED FOR UNKNOWN INDICATION SKIN BURNING SENSATION 12
C PRODUCT USED FOR UNKNOWN INDICATION SKIN CANCER 1
C PROSTATIC DISORDER CAROTID ARTERY OCCLUSION 2
C PROSTATIC DISORDER ERYTHEMA 2
C PROSTATIC DISORDER SKIN BURNING SENSATION 2
C RHEUMATOID ARTHRITIS CEREBRAL HAEMORRHAGE 4
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