Drug information for REQUIP XL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL EQ 12MG BASE Prescription   ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM 22008
2009-04-16 Label
2009-04-16 Letter
2008-12-29 Review
2008-11-07 Label
2008-11-03 Letter
2008-07-09 Label
2008-07-08 Letter
2008-06-20 Letter
2008-06-18 Label
TABLET, EXTENDED RELEASE; ORAL EQ 2MG BASE Prescription  (Reference Drug) ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL EQ 4MG BASE Prescription   ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL EQ 6MG BASE Prescription   ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL EQ 8MG BASE Prescription   ROPINIROLE HYDROCHLORIDE ropinirole SMITHKLINE BEECHAM   "

Drug Adverse Effects information for REQUIP XL

Role code Indications Reaction # Reports
PS DEPRESSION URINARY RETENTION 2
PS OVARIAN CANCER URINARY RETENTION 2
PS PARKINSON'S DISEASE ABASIA 1
PS PARKINSON'S DISEASE APHASIA 1
PS PARKINSON'S DISEASE ARTHRALGIA 1
PS PARKINSON'S DISEASE ASPARTATE AMINOTRANSFERASE INCREASED 1
PS PARKINSON'S DISEASE ASTHENIA 1
PS PARKINSON'S DISEASE BLOOD AMYLASE INCREASED 1
PS PARKINSON'S DISEASE BLOOD TESTOSTERONE INCREASED 1
PS PARKINSON'S DISEASE BLOOD UREA DECREASED 1
PS PARKINSON'S DISEASE DEHYDRATION 1
PS PARKINSON'S DISEASE DYSTONIA 1
PS PARKINSON'S DISEASE FATIGUE 1
PS PARKINSON'S DISEASE FIBRIN DEGRADATION PRODUCTS INCREASED 1
PS PARKINSON'S DISEASE FLUID RETENTION 1
PS PARKINSON'S DISEASE GRANULOCYTOSIS 1
PS PARKINSON'S DISEASE HALLUCINATION, VISUAL 3
PS PARKINSON'S DISEASE HYPERSEXUALITY 1
PS PARKINSON'S DISEASE HYPOKINESIA 1
PS PARKINSON'S DISEASE ILL-DEFINED DISORDER 1
PS PARKINSON'S DISEASE LABORATORY TEST ABNORMAL 1
PS PARKINSON'S DISEASE LIVER FUNCTION TEST ABNORMAL 1
PS PARKINSON'S DISEASE PARANOIA 1
PS PARKINSON'S DISEASE PROSTATIC SPECIFIC ANTIGEN INCREASED 1
PS PARKINSON'S DISEASE RENAL FAILURE 1
PS PARKINSON'S DISEASE RENAL FUNCTION TEST ABNORMAL 1
PS PARKINSON'S DISEASE SEXUAL ABUSE 1
PS PARKINSON'S DISEASE SEXUAL ACTIVITY INCREASED 1
PS PARKINSON'S DISEASE SUDDEN ONSET OF SLEEP 1
PS PARKINSON'S DISEASE SWELLING 1
PS PARKINSON'S DISEASE URINARY RETENTION 2
PS PARKINSON'S DISEASE URINARY TRACT INFECTION 1
PS PARKINSON'S DISEASE WEIGHT DECREASED 1
PS PARKINSON'S DISEASE WOUND 1
SS DEPRESSION FEELING JITTERY 2
SS DEPRESSION INITIAL INSOMNIA 2
SS DEPRESSION SLEEP DISORDER 2
SS FEELING JITTERY FEELING JITTERY 1
SS FEELING JITTERY INITIAL INSOMNIA 1
SS FEELING JITTERY SLEEP DISORDER 1
SS RESTLESS LEGS SYNDROME FEELING JITTERY 3
SS RESTLESS LEGS SYNDROME INITIAL INSOMNIA 3
SS RESTLESS LEGS SYNDROME SLEEP DISORDER 3
SS RHINITIS ALLERGIC FEELING JITTERY 2
SS RHINITIS ALLERGIC INITIAL INSOMNIA 2
SS RHINITIS ALLERGIC SLEEP DISORDER 2
C ASTHMA DRUG DOSE OMISSION 1
C ASTHMA DYSPNOEA 1
C ASTHMA HYPERTENSION 1
C ASTHMA PALPITATIONS 1
C ASTHMA RESPIRATORY DISTRESS 1
C BLOOD PRESSURE DRUG DOSE OMISSION 3
C BLOOD PRESSURE DYSPNOEA 3
C BLOOD PRESSURE HYPERTENSION 3
C BLOOD PRESSURE PALPITATIONS 3
C BLOOD PRESSURE RESPIRATORY DISTRESS 3
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DRUG DOSE OMISSION 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DYSPNOEA 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE HYPERTENSION 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE PALPITATIONS 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE RESPIRATORY DISTRESS 1
C DEPRESSION DRUG DOSE OMISSION 1
C DEPRESSION DYSPNOEA 1
C DEPRESSION HYPERTENSION 1
C DEPRESSION PALPITATIONS 1
C DEPRESSION RESPIRATORY DISTRESS 1
C PARKINSON'S DISEASE CONTUSION 1
C PARKINSON'S DISEASE COOMBS TEST POSITIVE 1
C PARKINSON'S DISEASE DRUG DOSE OMISSION 1
C PARKINSON'S DISEASE DRUG EFFECT DECREASED 2
C PARKINSON'S DISEASE DYSPNOEA 1
C PARKINSON'S DISEASE FREEZING PHENOMENON 2
C PARKINSON'S DISEASE GENERAL PHYSICAL HEALTH DETERIORATION 2
C PARKINSON'S DISEASE HALLUCINATION, VISUAL 2
C PARKINSON'S DISEASE HYPERTENSION 1
C PARKINSON'S DISEASE MALAISE 1
C PARKINSON'S DISEASE PALPITATIONS 1
C PARKINSON'S DISEASE RESPIRATORY DISTRESS 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS CEREBROVASCULAR ACCIDENT 1
C RESTLESS LEGS SYNDROME CEREBROVASCULAR ACCIDENT 1
C RESTRICTIVE PULMONARY DISEASE BACK PAIN 1
C RESTRICTIVE PULMONARY DISEASE MUSCULOSKELETAL PAIN 1
C RESTRICTIVE PULMONARY DISEASE MYALGIA 1
C RESTRICTIVE PULMONARY DISEASE PAIN IN EXTREMITY 1
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