Drug information for VIGAMOX

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION/DROPS; OPHTHALMIC	EQ 0.5% BASE	Prescription	(Reference Drug)	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin	ALCON PHARMS LTD	21598 2011-10-12 Letter 2011-10-12 Label 2005-04-08 Review 2004-07-01 Letter 2004-07-01 Label 2004-05-03 Label 2004-04-20 Letter 2003-10-10 Label 2003-10-10 Label 2003-10-03 Letter 2003-10-03 Letter 2003-05-29 Letter 2003-04-17 Label

Drug Adverse Effects information for VIGAMOX

Role code	Indications	Reaction	# Reports
PS	CATARACT OPERATION	BLINDNESS	5
PS	CATARACT OPERATION	ENDOPHTHALMITIS	5
PS	CATARACT OPERATION	EYE PAIN	5
PS	CATARACT OPERATION	HYPOTONIA	2
PS	CATARACT OPERATION	HYPOTONY OF EYE	3
PS	CATARACT OPERATION	PRODUCT SUBSTITUTION ISSUE	1
PS	CATARACT OPERATION	RASH ERYTHEMATOUS	1
PS	CATARACT OPERATION	RETINAL DETACHMENT	2
PS	CATARACT OPERATION	URTICARIA	1
PS	INFECTION PROPHYLAXIS	CORNEAL EROSION	2
PS	INFECTION PROPHYLAXIS	OFF LABEL USE	2
PS	POSTOPERATIVE CARE	BLINDNESS	4
PS	POSTOPERATIVE CARE	BLINDNESS UNILATERAL	3
PS	POSTOPERATIVE CARE	DRUG INEFFECTIVE	2
PS	POSTOPERATIVE CARE	DRUG RESISTANCE	1
PS	POSTOPERATIVE CARE	ENDOPHTHALMITIS	12
PS	POSTOPERATIVE CARE	EYE PAIN	10
PS	POSTOPERATIVE CARE	HYPOTONIA	7
PS	POSTOPERATIVE CARE	HYPOTONY OF EYE	3
PS	POSTOPERATIVE CARE	RETINAL DETACHMENT	4
PS	POSTOPERATIVE CARE	STAPHYLOCOCCUS TEST POSITIVE	1
PS	POSTOPERATIVE CARE	VISUAL ACUITY REDUCED	6
PS	PREOPERATIVE CARE	ANAPHYLACTIC SHOCK	1
PS	PREOPERATIVE CARE	BLINDNESS	4
PS	PREOPERATIVE CARE	CORNEAL EROSION	3
PS	PREOPERATIVE CARE	ENDOPHTHALMITIS	4
PS	PREOPERATIVE CARE	EYE PAIN	4
PS	PREOPERATIVE CARE	HYPOTONIA	4
PS	PREOPERATIVE CARE	OFF LABEL USE	4
PS	PREOPERATIVE CARE	RETINAL DETACHMENT	4
PS	PROPHYLAXIS	EYE IRRITATION	9
PS	PROPHYLAXIS	EYE PAIN	9
PS	PROPHYLAXIS	OFF LABEL USE	9
PS	PROPHYLAXIS	TOXIC ANTERIOR SEGMENT SYNDROME	9
SS	CATARACT OPERATION	ENDOPHTHALMITIS	12
SS	CATARACT OPERATION	TOXIC ANTERIOR SEGMENT SYNDROME	129
SS	CATARACT OPERATION	VISUAL ACUITY REDUCED	5
SS	EYE IRRIGATION	TOXIC ANTERIOR SEGMENT SYNDROME	3
SS	PREOPERATIVE CARE	TOXIC ANTERIOR SEGMENT SYNDROME	10
SS	PROPHYLAXIS	EYE IRRITATION	9
SS	PROPHYLAXIS	EYE PAIN	9
SS	PROPHYLAXIS	OFF LABEL USE	9
SS	PROPHYLAXIS	TOXIC ANTERIOR SEGMENT SYNDROME	9
C	AGE-RELATED MACULAR DEGENERATION	AORTIC VALVE STENOSIS	1
C	AGE-RELATED MACULAR DEGENERATION	CARDIAC DISORDER	1
C	AGE-RELATED MACULAR DEGENERATION	CEREBRAL INFARCTION	4
C	AGE-RELATED MACULAR DEGENERATION	CHEST PAIN	1
C	AGE-RELATED MACULAR DEGENERATION	DEATH	1
C	AGE-RELATED MACULAR DEGENERATION	RETINAL HAEMORRHAGE	2
C	AGE-RELATED MACULAR DEGENERATION	TACHYARRHYTHMIA	1
C	AGE-RELATED MACULAR DEGENERATION	VASCULAR RUPTURE	1
C	AGE-RELATED MACULAR DEGENERATION	VISUAL ACUITY REDUCED	1
C	ASTHMA	ADVERSE DRUG REACTION	1
C	ASTHMA	ASTHMA	1
C	ASTHMA	CIRCULATORY COLLAPSE	1
C	ASTHMA	DEATH	1
C	ASTHMA	DRUG INEFFECTIVE	1
C	ASTHMA	DYSPNOEA	1
C	ASTHMA	MALAISE	1
C	CONTRACEPTION	CHEST PAIN	1
C	CONTRACEPTION	DYSPNOEA	1
C	CONTRACEPTION	PULMONARY EMBOLISM	1
C	CORONARY ARTERY BYPASS	ANHEDONIA	1
C	CORONARY ARTERY BYPASS	ANXIETY	1
C	CORONARY ARTERY BYPASS	CEREBROVASCULAR ACCIDENT	1
C	CORONARY ARTERY BYPASS	DEATH	1
C	CORONARY ARTERY BYPASS	EMOTIONAL DISTRESS	1
C	CORONARY ARTERY BYPASS	FEAR	1
C	CORONARY ARTERY BYPASS	INJURY	1
C	CORONARY ARTERY BYPASS	MULTI-ORGAN FAILURE	1
C	CORONARY ARTERY BYPASS	PAIN	1
C	CORONARY ARTERY BYPASS	RENAL FAILURE	1
C	CORONARY ARTERY BYPASS	RENAL IMPAIRMENT	1
C	CORONARY ARTERY BYPASS	RENAL INJURY	1
C	CORONARY ARTERY BYPASS	STRESS	1
C	CORONARY ARTERY BYPASS	UNEVALUABLE EVENT	1
C	EAR INFECTION	ADVERSE DRUG REACTION	1
C	EAR INFECTION	ASTHMA	1
C	EAR INFECTION	CIRCULATORY COLLAPSE	1
C	EAR INFECTION	DEATH	1
C	EAR INFECTION	DRUG INEFFECTIVE	1
C	EAR INFECTION	DYSPNOEA	1
C	EAR INFECTION	MALAISE	1
C	ENDARTERECTOMY	ANHEDONIA	1
C	ENDARTERECTOMY	ANXIETY	1
C	ENDARTERECTOMY	CEREBROVASCULAR ACCIDENT	1
C	ENDARTERECTOMY	DEATH	1
C	ENDARTERECTOMY	EMOTIONAL DISTRESS	1
C	ENDARTERECTOMY	FEAR	1
C	ENDARTERECTOMY	INJURY	1
C	ENDARTERECTOMY	MULTI-ORGAN FAILURE	1
C	ENDARTERECTOMY	PAIN	1
C	ENDARTERECTOMY	RENAL FAILURE	1
C	ENDARTERECTOMY	RENAL IMPAIRMENT	1
C	ENDARTERECTOMY	RENAL INJURY	1
C	ENDARTERECTOMY	STRESS	1
C	ENDARTERECTOMY	UNEVALUABLE EVENT	1
C	EYE OPERATION	ANHEDONIA	1
C	EYE OPERATION	ANXIETY	1
C	EYE OPERATION	CEREBROVASCULAR ACCIDENT	1
C	EYE OPERATION	DEATH	1
C	EYE OPERATION	EMOTIONAL DISTRESS	1
C	EYE OPERATION	FEAR	1
C	EYE OPERATION	INJURY	1
C	EYE OPERATION	MULTI-ORGAN FAILURE	1
C	EYE OPERATION	PAIN	1
C	EYE OPERATION	RENAL FAILURE	1
C	EYE OPERATION	RENAL IMPAIRMENT	1
C	EYE OPERATION	RENAL INJURY	1
C	EYE OPERATION	STRESS	1
C	EYE OPERATION	UNEVALUABLE EVENT	1
C	GAIT DISTURBANCE	CATARACT OPERATION	1
C	GAIT DISTURBANCE	HYPERTENSION	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	CHEST PAIN	2
C	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPNOEA	2
C	GASTROOESOPHAGEAL REFLUX DISEASE	PULMONARY EMBOLISM	2
C	HEART RATE IRREGULAR	ABDOMINAL DISCOMFORT	1
C	HEART RATE IRREGULAR	ABDOMINAL PAIN UPPER	1
C	HEART RATE IRREGULAR	ADDISON'S DISEASE	1
C	HEART RATE IRREGULAR	ANAEMIA	1
C	HEART RATE IRREGULAR	ANHEDONIA	1
C	HEART RATE IRREGULAR	ANXIETY	1
C	HEART RATE IRREGULAR	APHAGIA	1
C	HEART RATE IRREGULAR	ASTHENIA	1
C	HEART RATE IRREGULAR	BALANCE DISORDER	1
C	HEART RATE IRREGULAR	BLOOD BILIRUBIN INCREASED	1
C	HEART RATE IRREGULAR	BLOOD GLUCOSE FLUCTUATION	1
C	HEART RATE IRREGULAR	BLOOD GLUCOSE INCREASED	1
C	HEART RATE IRREGULAR	BLOOD PRESSURE INCREASED	1
C	HEART RATE IRREGULAR	CHEST DISCOMFORT	1
C	HEART RATE IRREGULAR	CHOLELITHIASIS	1
C	HEART RATE IRREGULAR	DECREASED APPETITE	1
C	HEART RATE IRREGULAR	DEHYDRATION	1
C	HEART RATE IRREGULAR	DIARRHOEA	1
C	HEART RATE IRREGULAR	ECONOMIC PROBLEM	1
C	HEART RATE IRREGULAR	EJECTION FRACTION DECREASED	1
C	HEART RATE IRREGULAR	ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	1
C	HEART RATE IRREGULAR	ELECTROCARDIOGRAM ST-T CHANGE	1
C	HEART RATE IRREGULAR	EMOTIONAL DISORDER	1
C	HEART RATE IRREGULAR	ERUCTATION	1
C	HEART RATE IRREGULAR	FATIGUE	1
C	HEART RATE IRREGULAR	GASTRODUODENITIS	1
C	HEART RATE IRREGULAR	GLOMERULAR FILTRATION RATE DECREASED	1
C	HEART RATE IRREGULAR	HEART RATE INCREASED	1
C	HEART RATE IRREGULAR	HYPERKALAEMIA	1
C	HEART RATE IRREGULAR	HYPOMAGNESAEMIA	1
C	HEART RATE IRREGULAR	HYPONATRAEMIA	1
C	HEART RATE IRREGULAR	LARYNGITIS	1
C	HEART RATE IRREGULAR	MENTAL DISORDER	1
C	HEART RATE IRREGULAR	MITRAL VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	MULTIPLE INJURIES	1
C	HEART RATE IRREGULAR	MYOCARDIAL ISCHAEMIA	1
C	HEART RATE IRREGULAR	NAUSEA	1
C	HEART RATE IRREGULAR	NOCTURIA	1
C	HEART RATE IRREGULAR	OROPHARYNGEAL PAIN	1
C	HEART RATE IRREGULAR	PAIN	1
C	HEART RATE IRREGULAR	PALPITATIONS	1
C	HEART RATE IRREGULAR	PULMONARY HYPERTENSION	1
C	HEART RATE IRREGULAR	PULMONARY VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	RENAL CYST	1
C	HEART RATE IRREGULAR	SINUS TACHYCARDIA	1
C	HEART RATE IRREGULAR	TOXICITY TO VARIOUS AGENTS	1
C	HEART RATE IRREGULAR	TRICUSPID VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	URINARY TRACT INFECTION	1
C	HEART RATE IRREGULAR	VERTIGO	1
C	HEART RATE IRREGULAR	VIRAL INFECTION	1
C	HEART RATE IRREGULAR	WEIGHT DECREASED	1
C	HEPATIC NEOPLASM MALIGNANT	ERYTHEMA	1
C	HEPATIC NEOPLASM MALIGNANT	HEPATIC NEOPLASM MALIGNANT	1
C	HEPATIC NEOPLASM MALIGNANT	LYMPHADENOPATHY	1
C	HEPATIC NEOPLASM MALIGNANT	OEDEMA PERIPHERAL	1
C	HEPATIC NEOPLASM MALIGNANT	PAIN	1
C	PLEURISY	CHEST PAIN	5
C	PLEURISY	DYSPNOEA	5
C	PLEURISY	PULMONARY EMBOLISM	5
C	POSTMENOPAUSE	DRUG EFFECT DECREASED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	AORTIC VALVE STENOSIS	13
C	PRODUCT USED FOR UNKNOWN INDICATION	CARDIAC DISORDER	13
C	PRODUCT USED FOR UNKNOWN INDICATION	CEREBRAL INFARCTION	3
C	PRODUCT USED FOR UNKNOWN INDICATION	CHEST PAIN	13
C	PRODUCT USED FOR UNKNOWN INDICATION	DRUG EFFECT DECREASED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	RETINAL HAEMORRHAGE	4
C	PRODUCT USED FOR UNKNOWN INDICATION	TACHYARRHYTHMIA	13
C	PRODUCT USED FOR UNKNOWN INDICATION	VASCULAR RUPTURE	4
C	PRODUCT USED FOR UNKNOWN INDICATION	VISUAL ACUITY REDUCED	4
C	RHEUMATOID ARTHRITIS	ANAPHYLACTIC REACTION	2
C	RHEUMATOID ARTHRITIS	GRAND MAL CONVULSION	2

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