Drug information for ULTRAVIST 300

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	62.3%	Prescription	(Reference Drug)	IOPROMIDE	iopromide	BAYER HLTHCARE	20220 2012-05-07 Label 2012-05-04 Letter 2010-01-20 Letter 2010-01-08 Label 2010-01-05 Letter 2007-09-06 Letter 2007-09-04 Label 2005-08-15 Letter 2004-04-05 Label 2004-03-16 Letter 2003-05-29 Letter

Drug Adverse Effects information for ULTRAVIST 300

Role code	Indications	Reaction	# Reports
PS	ABDOMINAL PAIN	COLD SWEAT	1
PS	ABDOMINAL PAIN	ERYTHEMA	1
PS	ABDOMINAL PAIN	HEADACHE	1
PS	ABDOMINAL PAIN	HYPOVENTILATION	1
PS	ABDOMINAL PAIN	PALLOR	1
PS	ABDOMINAL PAIN	PRURITUS	1
PS	ABDOMINAL PAIN	RASH ERYTHEMATOUS	1
PS	ABDOMINAL PAIN	RASH MACULAR	1
PS	ABDOMINAL PAIN	RESPIRATORY RATE INCREASED	1
PS	ABDOMINAL PAIN	THROAT IRRITATION	1
PS	ABDOMINAL PAIN	URTICARIA	1
PS	ABDOMINAL PAIN LOWER	ANXIETY	1
PS	ABDOMINAL PAIN LOWER	DIZZINESS	1
PS	ABDOMINAL PAIN LOWER	DYSPNOEA	1
PS	ABDOMINAL PAIN LOWER	URTICARIA	1
PS	APPENDICITIS	COLD SWEAT	1
PS	APPENDICITIS	ERYTHEMA	1
PS	APPENDICITIS	HEADACHE	1
PS	APPENDICITIS	HYPOVENTILATION	1
PS	APPENDICITIS	PALLOR	1
PS	APPENDICITIS	PRURITUS	1
PS	APPENDICITIS	RASH ERYTHEMATOUS	1
PS	APPENDICITIS	RASH MACULAR	1
PS	APPENDICITIS	RESPIRATORY RATE INCREASED	1
PS	APPENDICITIS	URTICARIA	1
PS	CARCINOID TUMOUR	NAUSEA	1
PS	CARCINOID TUMOUR	VOMITING	1
PS	CHEST X-RAY ABNORMAL	VOMITING	1
PS	COMPUTERISED TOMOGRAM	ANXIETY	1
PS	COMPUTERISED TOMOGRAM	CHEST DISCOMFORT	1
PS	COMPUTERISED TOMOGRAM	DIZZINESS	1
PS	COMPUTERISED TOMOGRAM	DYSPNOEA	1
PS	COMPUTERISED TOMOGRAM	EAR PRURITUS	1
PS	COMPUTERISED TOMOGRAM	EYE PRURITUS	1
PS	COMPUTERISED TOMOGRAM	NASAL CONGESTION	2
PS	COMPUTERISED TOMOGRAM	NAUSEA	1
PS	COMPUTERISED TOMOGRAM	OROPHARYNGEAL PAIN	1
PS	COMPUTERISED TOMOGRAM	RASH	1
PS	COMPUTERISED TOMOGRAM	RASH GENERALISED	1
PS	COMPUTERISED TOMOGRAM	SNEEZING	1
PS	COMPUTERISED TOMOGRAM	THROAT IRRITATION	1
PS	COMPUTERISED TOMOGRAM	URTICARIA	3
PS	COMPUTERISED TOMOGRAM	VOMITING	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	ANXIETY	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	COLD SWEAT	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	COUGH	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	DIZZINESS	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	DYSPNOEA	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	EAR PRURITUS	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	ERYTHEMA	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	EYE PRURITUS	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	FLUSHING	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	HEADACHE	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	HYPOVENTILATION	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	NASAL CONGESTION	5
PS	COMPUTERISED TOMOGRAM ABDOMEN	PALLOR	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	PRURITUS	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	RASH ERYTHEMATOUS	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	RASH MACULAR	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	RESPIRATORY RATE INCREASED	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	RHINORRHOEA	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	SNEEZING	4
PS	COMPUTERISED TOMOGRAM ABDOMEN	THROAT IRRITATION	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	URTICARIA	6
PS	COMPUTERISED TOMOGRAM HEAD	MUSCLE SPASMS	3
PS	COMPUTERISED TOMOGRAM HEAD	PRODUCT QUALITY ISSUE	1
PS	COMPUTERISED TOMOGRAM HEAD	SYNCOPE	3
PS	COMPUTERISED TOMOGRAM THORAX	COUGH	1
PS	COMPUTERISED TOMOGRAM THORAX	EAR PRURITUS	1
PS	COMPUTERISED TOMOGRAM THORAX	EYE PRURITUS	1
PS	COMPUTERISED TOMOGRAM THORAX	NASAL CONGESTION	1
PS	COMPUTERISED TOMOGRAM THORAX	PRURITUS	1
PS	COMPUTERISED TOMOGRAM THORAX	RHINORRHOEA	1
PS	COMPUTERISED TOMOGRAM THORAX	THROAT IRRITATION	1
PS	COMPUTERISED TOMOGRAM THORAX	URTICARIA	1
PS	COMPUTERISED TOMOGRAM THORAX	VOMITING	1
PS	COUGH	VOMITING	1
PS	DIARRHOEA	URTICARIA	1
PS	DIVERTICULITIS	NASAL CONGESTION	1
PS	DIVERTICULITIS	SNEEZING	1
PS	DIVERTICULITIS	URTICARIA	1
PS	FLANK PAIN	ANXIETY	1
PS	FLANK PAIN	DIZZINESS	1
PS	FLANK PAIN	DYSPNOEA	1
PS	GASTRIC CANCER	URTICARIA	1
PS	IRRITABLE BOWEL SYNDROME	NAUSEA	1
PS	IRRITABLE BOWEL SYNDROME	VOMITING	1
PS	LYMPHOMA	ERYTHEMA	1
PS	LYMPHOMA	FLUSHING	1
PS	RENAL CANCER	NASAL CONGESTION	1
PS	RENAL CANCER	SNEEZING	1
SS	ABDOMINAL PAIN	COLD SWEAT	2
SS	ABDOMINAL PAIN	ERYTHEMA	2
SS	ABDOMINAL PAIN	HEADACHE	2
SS	ABDOMINAL PAIN	HYPOVENTILATION	2
SS	ABDOMINAL PAIN	PALLOR	2
SS	ABDOMINAL PAIN	PRURITUS	2
SS	ABDOMINAL PAIN	RASH ERYTHEMATOUS	2
SS	ABDOMINAL PAIN	RASH MACULAR	2
SS	ABDOMINAL PAIN	RESPIRATORY RATE INCREASED	2
SS	ABDOMINAL PAIN	URTICARIA	2
SS	ABDOMINAL PAIN LOWER	ANXIETY	2
SS	ABDOMINAL PAIN LOWER	DIZZINESS	2
SS	ABDOMINAL PAIN LOWER	DYSPNOEA	2
SS	ABDOMINAL PAIN LOWER	URTICARIA	2
SS	APPENDICITIS	COLD SWEAT	2
SS	APPENDICITIS	ERYTHEMA	2
SS	APPENDICITIS	HEADACHE	2
SS	APPENDICITIS	HYPOVENTILATION	2
SS	APPENDICITIS	PALLOR	2
SS	APPENDICITIS	PRURITUS	2
SS	APPENDICITIS	RASH ERYTHEMATOUS	2
SS	APPENDICITIS	RASH MACULAR	2
SS	APPENDICITIS	RESPIRATORY RATE INCREASED	2
SS	APPENDICITIS	URTICARIA	2
SS	CARCINOID TUMOUR	NAUSEA	2
SS	CARCINOID TUMOUR	VOMITING	2
SS	CHEST X-RAY ABNORMAL	VOMITING	2
SS	COMPUTERISED TOMOGRAM	ANXIETY	2
SS	COMPUTERISED TOMOGRAM	DIZZINESS	2
SS	COMPUTERISED TOMOGRAM	DYSPNOEA	2
SS	COMPUTERISED TOMOGRAM	EAR PRURITUS	1
SS	COMPUTERISED TOMOGRAM	EYE PRURITUS	1
SS	COMPUTERISED TOMOGRAM	NASAL CONGESTION	1
SS	COMPUTERISED TOMOGRAM	NAUSEA	2
SS	COMPUTERISED TOMOGRAM	SNEEZING	1
SS	COMPUTERISED TOMOGRAM	URTICARIA	1
SS	COMPUTERISED TOMOGRAM	VOMITING	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	ANXIETY	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	COLD SWEAT	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	COUGH	4
SS	COMPUTERISED TOMOGRAM ABDOMEN	DIZZINESS	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	DYSPNOEA	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	EAR PRURITUS	5
SS	COMPUTERISED TOMOGRAM ABDOMEN	ERYTHEMA	3
SS	COMPUTERISED TOMOGRAM ABDOMEN	EYE PRURITUS	5
SS	COMPUTERISED TOMOGRAM ABDOMEN	FLUSHING	1
SS	COMPUTERISED TOMOGRAM ABDOMEN	HEADACHE	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	HYPOVENTILATION	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	NASAL CONGESTION	8
SS	COMPUTERISED TOMOGRAM ABDOMEN	PALLOR	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	PRURITUS	6
SS	COMPUTERISED TOMOGRAM ABDOMEN	RASH ERYTHEMATOUS	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	RASH MACULAR	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	RESPIRATORY RATE INCREASED	2
SS	COMPUTERISED TOMOGRAM ABDOMEN	RHINORRHOEA	4
SS	COMPUTERISED TOMOGRAM ABDOMEN	SNEEZING	4
SS	COMPUTERISED TOMOGRAM ABDOMEN	THROAT IRRITATION	4
SS	COMPUTERISED TOMOGRAM ABDOMEN	URTICARIA	9
SS	COMPUTERISED TOMOGRAM THORAX	COUGH	4
SS	COMPUTERISED TOMOGRAM THORAX	EAR PRURITUS	4
SS	COMPUTERISED TOMOGRAM THORAX	EYE PRURITUS	4
SS	COMPUTERISED TOMOGRAM THORAX	NASAL CONGESTION	4
SS	COMPUTERISED TOMOGRAM THORAX	PRURITUS	4
SS	COMPUTERISED TOMOGRAM THORAX	RHINORRHOEA	4
SS	COMPUTERISED TOMOGRAM THORAX	THROAT IRRITATION	4
SS	COMPUTERISED TOMOGRAM THORAX	URTICARIA	1
SS	COMPUTERISED TOMOGRAM THORAX	VOMITING	2
SS	COUGH	VOMITING	2
SS	DIARRHOEA	URTICARIA	2
SS	DIVERTICULITIS	NASAL CONGESTION	1
SS	DIVERTICULITIS	SNEEZING	1
SS	DIVERTICULITIS	URTICARIA	1
SS	FLANK PAIN	ANXIETY	2
SS	FLANK PAIN	DIZZINESS	2
SS	FLANK PAIN	DYSPNOEA	2
SS	GASTRIC CANCER	URTICARIA	1
SS	IRRITABLE BOWEL SYNDROME	NAUSEA	2
SS	IRRITABLE BOWEL SYNDROME	VOMITING	2
SS	LYMPHOMA	ERYTHEMA	1
SS	LYMPHOMA	FLUSHING	1
SS	RENAL CANCER	NASAL CONGESTION	1
SS	RENAL CANCER	SNEEZING	1
C	ANAL INJURY	CONFUSIONAL STATE	2
C	ANXIETY	CONFUSIONAL STATE	1
C	BACK PAIN	CONFUSIONAL STATE	2
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CONFUSIONAL STATE	3
C	CLOSTRIDIUM DIFFICILE COLITIS	CONFUSIONAL STATE	1
C	CONFUSIONAL STATE	CONFUSIONAL STATE	1
C	DERMATITIS	CONFUSIONAL STATE	3
C	DIARRHOEA	CONFUSIONAL STATE	1
C	DYSURIA	CONFUSIONAL STATE	1
C	HEPATIC ENCEPHALOPATHY	CONFUSIONAL STATE	1
C	HEPATIC NEOPLASM MALIGNANT	CONFUSIONAL STATE	4
C	HEPATIC NEOPLASM MALIGNANT	OFF LABEL USE	2
C	HYPERLIPIDAEMIA	CONFUSIONAL STATE	1
C	HYPERTENSION	CONFUSIONAL STATE	2
C	INSOMNIA	CONFUSIONAL STATE	4
C	MEDICAL DIET	CONFUSIONAL STATE	1
C	NASAL CONGESTION	CONFUSIONAL STATE	1
C	NAUSEA	CONFUSIONAL STATE	5
C	OSTEOPOROSIS	CONFUSIONAL STATE	1
C	PARONYCHIA	CONFUSIONAL STATE	3
C	PORTAL HYPERTENSION	CONFUSIONAL STATE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	CONFUSIONAL STATE	20
C	PRODUCT USED FOR UNKNOWN INDICATION	OFF LABEL USE	20
C	PROPHYLAXIS	CONFUSIONAL STATE	2
C	PROPHYLAXIS	OFF LABEL USE	1
C	RASH	CONFUSIONAL STATE	3
C	RESPIRATORY TRACT INFECTION	CONFUSIONAL STATE	2
C	SCAN WITH CONTRAST	CONFUSIONAL STATE	2
C	SMOKING CESSATION THERAPY	CONFUSIONAL STATE	1
C	THROMBOSIS PROPHYLAXIS	CONFUSIONAL STATE	1
C	TYPE 2 DIABETES MELLITUS	CONFUSIONAL STATE	2
C	URINARY TRACT INFECTION	CONFUSIONAL STATE	1
C	UROSEPSIS	CONFUSIONAL STATE	4
C	VITAMIN SUPPLEMENTATION	CONFUSIONAL STATE	1
C	WHEEZING	CONFUSIONAL STATE	1

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