Drug information for CLARITIN-D

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET, EXTENDED RELEASE; ORAL	5MG;120MG	Over The Counter	(Reference Drug)	LORATADINE; PSEUDOEPHEDRINE SULFATE	Sch 434	SCHERING PLOUGH	19670 2011-12-16 Review 2010-02-17 Letter 2009-04-27 Letter 2007-03-02 Review 2007-03-02 Review 2007-03-02 Review 2007-03-02 Review 2007-03-02 Review 2007-03-02 Review 2007-03-02 Review 2004-12-07 Review 2004-08-02 Letter 2004-08-02 Label 2002-11-27 Letter

Drug Adverse Effects information for CLARITIN-D

Role code	Indications	Reaction	# Reports
PS	HYPERSENSITIVITY	EXFOLIATIVE RASH	1
PS	HYPERSENSITIVITY	INSOMNIA	1
PS	HYPERSENSITIVITY	MUSCLE SPASMS	1
PS	HYPERSENSITIVITY	TACHYCARDIA	1
PS	NASAL CONGESTION	EXFOLIATIVE RASH	1
PS	NASAL CONGESTION	INSOMNIA	1
PS	NASAL CONGESTION	MUSCLE SPASMS	1
PS	NASAL CONGESTION	TACHYCARDIA	1
SS	EAR INFECTION	ERYTHEMA	2
SS	EAR INFECTION	HYPERSENSITIVITY	2
SS	EAR INFECTION	SWELLING	2
C	ACNE CYSTIC	ANXIETY	1
C	ACNE CYSTIC	COLITIS	1
C	ACNE CYSTIC	COLITIS ULCERATIVE	1
C	ACNE CYSTIC	CROHN'S DISEASE	1
C	ACNE CYSTIC	DEPRESSION	1
C	ACNE CYSTIC	GASTROINTESTINAL DISORDER	1
C	ACNE CYSTIC	HYPERTENSION	1
C	ACNE CYSTIC	HYPOPHOSPHATAEMIA	1
C	ACNE CYSTIC	INFLAMMATORY BOWEL DISEASE	1
C	ACNE CYSTIC	INTESTINAL HAEMORRHAGE	1
C	ACNE CYSTIC	SINUS ARRHYTHMIA	1
C	ACNE CYSTIC	SUPRAVENTRICULAR TACHYCARDIA	1
C	ACNE CYSTIC	URINARY RETENTION	1
C	AFFECTIVE DISORDER	DIZZINESS	1
C	AFFECTIVE DISORDER	DRUG WITHDRAWAL SYNDROME	1
C	AFFECTIVE DISORDER	HEADACHE	1
C	AFFECTIVE DISORDER	NAUSEA	1
C	ANTIALLERGIC THERAPY	ANAEMIA	4
C	ANTIALLERGIC THERAPY	PNEUMONIA BACTERIAL	4
C	ANTIALLERGIC THERAPY	RENAL FAILURE ACUTE	4
C	ASTHMA	DYSPNOEA	1
C	ASTHMA	WHEEZING	1
C	BRONCHITIS	ANXIETY	8
C	BRONCHITIS	DEPRESSION	8
C	BRONCHITIS	EPICONDYLITIS	8
C	BRONCHITIS	POST-TRAUMATIC STRESS DISORDER	8
C	BRONCHITIS	ROTATOR CUFF SYNDROME	8
C	BRONCHITIS	TENDONITIS	8
C	CHRONIC MYELOID LEUKAEMIA	AMNESIA	1
C	CHRONIC MYELOID LEUKAEMIA	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	1
C	CHRONIC MYELOID LEUKAEMIA	CONCOMITANT DISEASE AGGRAVATED	1
C	CHRONIC MYELOID LEUKAEMIA	DECREASED APPETITE	1
C	CHRONIC MYELOID LEUKAEMIA	FLUID RETENTION	1
C	CHRONIC MYELOID LEUKAEMIA	OEDEMA PERIPHERAL	1
C	CHRONIC MYELOID LEUKAEMIA	WEIGHT DECREASED	1
C	CONTRACEPTION	ABDOMINAL PAIN UPPER	2
C	CONTRACEPTION	AORTIC VALVE INCOMPETENCE	1
C	CONTRACEPTION	BREAST PAIN	1
C	CONTRACEPTION	BREAST SWELLING	1
C	CONTRACEPTION	CHOLECYSTITIS ACUTE	2
C	CONTRACEPTION	CHOLELITHIASIS	2
C	CONTRACEPTION	DEPRESSION	1
C	CONTRACEPTION	EMOTIONAL DISORDER	1
C	CONTRACEPTION	INJURY	2
C	CONTRACEPTION	IRRITABILITY	1
C	CONTRACEPTION	ISCHAEMIC CEREBRAL INFARCTION	1
C	CONTRACEPTION	MENTAL DISORDER	1
C	CONTRACEPTION	MIGRAINE	1
C	CONTRACEPTION	PAPILLOMA VIRAL INFECTION	1
C	CONTRACEPTION	PHARYNGITIS STREPTOCOCCAL	1
C	CONTRACEPTION	TRANSIENT ISCHAEMIC ATTACK	1
C	CROHN'S DISEASE	ANAEMIA	4
C	CROHN'S DISEASE	PNEUMONIA BACTERIAL	4
C	CROHN'S DISEASE	RENAL FAILURE ACUTE	4
C	DIABETES MELLITUS	ABDOMINAL DISCOMFORT	1
C	DIABETES MELLITUS	GASTRITIS	1
C	DIABETES MELLITUS	NEPHROPATHY	1
C	DIABETES MELLITUS	OFF LABEL USE	1
C	DIABETES MELLITUS	PANCREATITIS	1
C	DIABETES MELLITUS	RENAL FAILURE	1
C	HEADACHE	ERYTHEMA	1
C	HEADACHE	HYPERSENSITIVITY	1
C	HEADACHE	SWELLING FACE	1
C	HEADACHE	SWOLLEN TONGUE	1
C	HOT FLUSH	DIZZINESS	1
C	HOT FLUSH	DRUG WITHDRAWAL SYNDROME	1
C	HOT FLUSH	HEADACHE	1
C	HOT FLUSH	NAUSEA	1
C	HYPERSENSITIVITY	DIZZINESS	1
C	HYPERSENSITIVITY	DRUG WITHDRAWAL SYNDROME	1
C	HYPERSENSITIVITY	HEADACHE	1
C	HYPERSENSITIVITY	NAUSEA	1
C	HYPERTENSION	ANXIETY	1
C	HYPERTENSION	COLITIS	1
C	HYPERTENSION	COLITIS ULCERATIVE	1
C	HYPERTENSION	CROHN'S DISEASE	1
C	HYPERTENSION	DEPRESSION	1
C	HYPERTENSION	GASTROINTESTINAL DISORDER	1
C	HYPERTENSION	HYPERTENSION	1
C	HYPERTENSION	HYPOPHOSPHATAEMIA	1
C	HYPERTENSION	INFLAMMATORY BOWEL DISEASE	1
C	HYPERTENSION	INTESTINAL HAEMORRHAGE	1
C	HYPERTENSION	SINUS ARRHYTHMIA	1
C	HYPERTENSION	SUPRAVENTRICULAR TACHYCARDIA	1
C	HYPERTENSION	URINARY RETENTION	1
C	MENSTRUATION IRREGULAR	DEEP VEIN THROMBOSIS	1
C	MENSTRUATION IRREGULAR	PULMONARY EMBOLISM	1
C	MULTIPLE SCLEROSIS	ERYTHEMA	1
C	MULTIPLE SCLEROSIS	INJECTION SITE ERYTHEMA	1
C	MULTIPLE SCLEROSIS	INJECTION SITE PRURITUS	1
C	MULTIPLE SCLEROSIS	INJECTION SITE REACTION	1
C	MULTIPLE SCLEROSIS	INSOMNIA	1
C	OSTEOPENIA	ANAEMIA	8
C	OSTEOPENIA	PNEUMONIA BACTERIAL	8
C	OSTEOPENIA	RENAL FAILURE ACUTE	8
C	PRODUCT USED FOR UNKNOWN INDICATION	AORTIC VALVE INCOMPETENCE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	BREAST PAIN	1
C	PRODUCT USED FOR UNKNOWN INDICATION	BREAST SWELLING	1
C	PRODUCT USED FOR UNKNOWN INDICATION	DEPRESSION	1
C	PRODUCT USED FOR UNKNOWN INDICATION	EMOTIONAL DISORDER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	IRRITABILITY	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIC CEREBRAL INFARCTION	1
C	PRODUCT USED FOR UNKNOWN INDICATION	MENTAL DISORDER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	MIGRAINE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	PAPILLOMA VIRAL INFECTION	1
C	PRODUCT USED FOR UNKNOWN INDICATION	PHARYNGITIS STREPTOCOCCAL	1
C	PRODUCT USED FOR UNKNOWN INDICATION	TRANSIENT ISCHAEMIC ATTACK	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	ABDOMINAL DISCOMFORT	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	BLEPHAROSPASM	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	BURNING SENSATION	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	CONSTIPATION	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	CRANIAL NERVE DISORDER	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	EYELID PTOSIS	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	FACIAL SPASM	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	GLYCOSYLATED HAEMOGLOBIN INCREASED	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	HEMIPARESIS	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	HYPERHIDROSIS	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	HYPOAESTHESIA	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	INSOMNIA	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	LYMPHOCYTE COUNT DECREASED	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	MULTIPLE SCLEROSIS RELAPSE	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	PERONEAL NERVE PALSY	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	SHOULDER DEFORMITY	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	VISION BLURRED	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	VISUAL FIELD DEFECT	1
C	SEASONAL ALLERGY	ABDOMINAL PAIN UPPER	2
C	SEASONAL ALLERGY	ANAEMIA	4
C	SEASONAL ALLERGY	CHOLECYSTITIS ACUTE	2
C	SEASONAL ALLERGY	CHOLELITHIASIS	2
C	SEASONAL ALLERGY	INJURY	2
C	SEASONAL ALLERGY	PNEUMONIA BACTERIAL	4
C	SEASONAL ALLERGY	RENAL FAILURE ACUTE	4
C	SINUS DISORDER	ANXIETY	6
C	SINUS DISORDER	DEPRESSION	6
C	SINUS DISORDER	EPICONDYLITIS	6
C	SINUS DISORDER	POST-TRAUMATIC STRESS DISORDER	6
C	SINUS DISORDER	ROTATOR CUFF SYNDROME	6
C	SINUS DISORDER	TENDONITIS	6
C	SINUSITIS	ANXIETY	2
C	SINUSITIS	DEPRESSION	2
C	SINUSITIS	EPICONDYLITIS	2
C	SINUSITIS	POST-TRAUMATIC STRESS DISORDER	2
C	SINUSITIS	ROTATOR CUFF SYNDROME	2
C	SINUSITIS	TENDONITIS	2
C	TOBACCO USER	ANAEMIA	4
C	TOBACCO USER	PNEUMONIA BACTERIAL	4
C	TOBACCO USER	RENAL FAILURE ACUTE	4
C	VITAMIN SUPPLEMENTATION	ANAEMIA	8
C	VITAMIN SUPPLEMENTATION	PNEUMONIA BACTERIAL	8
C	VITAMIN SUPPLEMENTATION	RENAL FAILURE ACUTE	8

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