Drug information for RYTHMOL SR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 225MG Prescription AB  PROPAFENONE HYDROCHLORIDE Propafenone GLAXOSMITHKLINE LLC 21416
2011-04-19 Letter

2011-04-15 Label

2010-11-03 Letter

2010-10-29 Label

2004-09-15 Letter

2004-02-11 Review

2003-09-25 Letter

2003-09-25 Label
CAPSULE, EXTENDED RELEASE; ORAL 325MG Prescription AB  PROPAFENONE HYDROCHLORIDE Propafenone GLAXOSMITHKLINE LLC   "
CAPSULE, EXTENDED RELEASE; ORAL 425MG Prescription AB (Reference Drug) PROPAFENONE HYDROCHLORIDE Propafenone GLAXOSMITHKLINE LLC   "

Drug Adverse Effects information for RYTHMOL SR

Role code Indications Reaction # Reports
PS ARRHYTHMIA ANXIETY 1
PS ARRHYTHMIA DRUG INEFFECTIVE 2
PS ARRHYTHMIA DYSPNOEA 1
PS ARRHYTHMIA ERUCTATION 1
PS ARRHYTHMIA NAUSEA 1
PS ARRHYTHMIA PRODUCT QUALITY ISSUE 2
PS ARRHYTHMIA SINUS HEADACHE 1
PS ATRIAL FIBRILLATION ABASIA 2
PS ATRIAL FIBRILLATION ABDOMINAL DISCOMFORT 1
PS ATRIAL FIBRILLATION ABDOMINAL PAIN 1
PS ATRIAL FIBRILLATION ABDOMINAL PAIN UPPER 1
PS ATRIAL FIBRILLATION ASTHENIA 5
PS ATRIAL FIBRILLATION ATRIAL FIBRILLATION 4
PS ATRIAL FIBRILLATION BALANCE DISORDER 1
PS ATRIAL FIBRILLATION BLINDNESS 1
PS ATRIAL FIBRILLATION CARDIOVERSION 2
PS ATRIAL FIBRILLATION CEREBROVASCULAR ACCIDENT 1
PS ATRIAL FIBRILLATION CHEST DISCOMFORT 1
PS ATRIAL FIBRILLATION CONSTIPATION 1
PS ATRIAL FIBRILLATION DIARRHOEA 1
PS ATRIAL FIBRILLATION DIZZINESS 5
PS ATRIAL FIBRILLATION DRUG ADMINISTRATION ERROR 2
PS ATRIAL FIBRILLATION DRUG HYPERSENSITIVITY 1
PS ATRIAL FIBRILLATION DRUG INEFFECTIVE 10
PS ATRIAL FIBRILLATION DYSGEUSIA 1
PS ATRIAL FIBRILLATION DYSPNOEA 2
PS ATRIAL FIBRILLATION EJECTION FRACTION DECREASED 1
PS ATRIAL FIBRILLATION ERYTHEMA 1
PS ATRIAL FIBRILLATION EXTRASYSTOLES 1
PS ATRIAL FIBRILLATION EYE HAEMORRHAGE 1
PS ATRIAL FIBRILLATION FALL 1
PS ATRIAL FIBRILLATION FATIGUE 2
PS ATRIAL FIBRILLATION FEELING ABNORMAL 1
PS ATRIAL FIBRILLATION FEELING HOT 1
PS ATRIAL FIBRILLATION FLUSHING 1
PS ATRIAL FIBRILLATION GAIT DISTURBANCE 3
PS ATRIAL FIBRILLATION GINGIVAL ULCERATION 2
PS ATRIAL FIBRILLATION HEADACHE 2
PS ATRIAL FIBRILLATION HEART RATE DECREASED 2
PS ATRIAL FIBRILLATION HEART RATE INCREASED 1
PS ATRIAL FIBRILLATION HYPERHIDROSIS 2
PS ATRIAL FIBRILLATION HYPOAESTHESIA 1
PS ATRIAL FIBRILLATION HYPOTENSION 2
PS ATRIAL FIBRILLATION MUSCULAR WEAKNESS 2
PS ATRIAL FIBRILLATION NAUSEA 1
PS ATRIAL FIBRILLATION NECK PAIN 2
PS ATRIAL FIBRILLATION NORMOCHROMIC NORMOCYTIC ANAEMIA 1
PS ATRIAL FIBRILLATION OVERDOSE 4
PS ATRIAL FIBRILLATION PALPITATIONS 1
PS ATRIAL FIBRILLATION PRODUCT QUALITY ISSUE 3
PS ATRIAL FIBRILLATION RASH 1
PS ATRIAL FIBRILLATION SENSORY LOSS 1
PS ATRIAL FIBRILLATION SWELLING 1
PS ATRIAL FIBRILLATION TINNITUS 1
PS ATRIAL FIBRILLATION TREMOR 5
PS ATRIAL FIBRILLATION VISION BLURRED 2
PS ATRIAL FIBRILLATION VOMITING 1
PS BLOOD PRESSURE ABASIA 1
PS BLOOD PRESSURE ASTHENIA 1
PS BLOOD PRESSURE CARDIOVERSION 1
PS BLOOD PRESSURE DIZZINESS 1
PS BLOOD PRESSURE DRUG ADMINISTRATION ERROR 1
PS BLOOD PRESSURE DRUG INEFFECTIVE 1
PS BLOOD PRESSURE DYSPNOEA 1
PS BLOOD PRESSURE GAIT DISTURBANCE 1
PS BLOOD PRESSURE HEART RATE DECREASED 1
PS BLOOD PRESSURE HYPERHIDROSIS 1
PS BLOOD PRESSURE HYPOTENSION 1
PS BLOOD PRESSURE OVERDOSE 1
PS HEART RATE INCREASED DRUG INEFFECTIVE 1
PS HEART RATE IRREGULAR BACK PAIN 1
PS HEART RATE IRREGULAR ERUCTATION 1
PS HEART RATE IRREGULAR FLATULENCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 2
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 2
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN UPPER 2
PS PRODUCT USED FOR UNKNOWN INDICATION ADVERSE EVENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
PS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION BEDRIDDEN 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 2
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG HYPERSENSITIVITY 2
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSGEUSIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 2
PS PRODUCT USED FOR UNKNOWN INDICATION PALPITATIONS 1
PS SUPRAVENTRICULAR TACHYCARDIA CARDIAC DISORDER 2
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