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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