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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