Drug information for PATANASE

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SPRAY, METERED; NASAL	0.665MG/SPRAY	Prescription	(Reference Drug)	OLOPATADINE HYDROCHLORIDE	olopatadine	ALCON PHARMS LTD	21861 2012-02-27 Letter 2012-02-24 Label 2010-04-05 Letter 2010-04-04 Label 2010-03-19 Review 2010-01-26 Letter 2009-12-02 Label 2008-04-23 Label 2008-04-22 Letter

Drug Adverse Effects information for PATANASE

Role code	Indications	Reaction	# Reports
PS	MULTIPLE ALLERGIES	ANAPHYLACTIC REACTION	1
PS	MULTIPLE ALLERGIES	PHARYNGEAL OEDEMA	1
PS	MULTIPLE ALLERGIES	PRURITUS	1
PS	MULTIPLE ALLERGIES	URTICARIA	1
SS	MULTIPLE ALLERGIES	ANAPHYLACTIC REACTION	1
SS	MULTIPLE ALLERGIES	PHARYNGEAL OEDEMA	1
SS	MULTIPLE ALLERGIES	PRURITUS	1
SS	MULTIPLE ALLERGIES	URTICARIA	1
C	ANALGESIC THERAPY	MUSCULOSKELETAL DISORDER	1
C	ANALGESIC THERAPY	NEUROPATHY PERIPHERAL	1
C	ANALGESIC THERAPY	THROMBOSIS	1
C	ANGINA PECTORIS	MUSCULOSKELETAL DISORDER	1
C	ANGINA PECTORIS	NEUROPATHY PERIPHERAL	1
C	ANGINA PECTORIS	THROMBOSIS	1
C	ANTICOAGULANT THERAPY	MUSCULOSKELETAL DISORDER	1
C	ANTICOAGULANT THERAPY	NEUROPATHY PERIPHERAL	1
C	ANTICOAGULANT THERAPY	THROMBOSIS	1
C	ASTHMA	BURNING SENSATION	1
C	ASTHMA	COELIAC DISEASE	5
C	ASTHMA	DRY EYE	1
C	ASTHMA	DYSPNOEA	1
C	ASTHMA	FATIGUE	1
C	ASTHMA	OEDEMA PERIPHERAL	1
C	ASTHMA	TOOTH EROSION	1
C	BACK INJURY	MUSCULOSKELETAL DISORDER	1
C	BACK INJURY	NEUROPATHY PERIPHERAL	1
C	BACK INJURY	THROMBOSIS	1
C	BLOOD CHOLESTEROL ABNORMAL	MUSCULOSKELETAL DISORDER	2
C	BLOOD CHOLESTEROL ABNORMAL	NEUROPATHY PERIPHERAL	2
C	BLOOD CHOLESTEROL ABNORMAL	THROMBOSIS	2
C	BLOOD POTASSIUM DECREASED	MUSCULOSKELETAL DISORDER	1
C	BLOOD POTASSIUM DECREASED	NEUROPATHY PERIPHERAL	1
C	BLOOD POTASSIUM DECREASED	THROMBOSIS	1
C	CARDIAC DISORDER	MUSCULOSKELETAL DISORDER	2
C	CARDIAC DISORDER	NEUROPATHY PERIPHERAL	2
C	CARDIAC DISORDER	THROMBOSIS	2
C	CHRONIC FATIGUE SYNDROME	BLISTER	3
C	CHRONIC FATIGUE SYNDROME	SKIN EXFOLIATION	3
C	CHRONIC FATIGUE SYNDROME	SKIN IRRITATION	3
C	CONTRACEPTION	BLISTER	3
C	CONTRACEPTION	SKIN EXFOLIATION	3
C	CONTRACEPTION	SKIN IRRITATION	3
C	FIBROMYALGIA	BLISTER	3
C	FIBROMYALGIA	SKIN EXFOLIATION	3
C	FIBROMYALGIA	SKIN IRRITATION	3
C	GASTRIC DISORDER	MUSCULOSKELETAL DISORDER	1
C	GASTRIC DISORDER	NEUROPATHY PERIPHERAL	1
C	GASTRIC DISORDER	THROMBOSIS	1
C	HYPERCHOLESTEROLAEMIA	ABDOMINAL PAIN LOWER	1
C	HYPERCHOLESTEROLAEMIA	ANAEMIA	1
C	HYPERCHOLESTEROLAEMIA	ANGINA PECTORIS	1
C	HYPERCHOLESTEROLAEMIA	ASTHENIA	1
C	HYPERCHOLESTEROLAEMIA	BACK PAIN	1
C	HYPERCHOLESTEROLAEMIA	BLOOD CREATINE PHOSPHOKINASE INCREASED	1
C	HYPERCHOLESTEROLAEMIA	BLOOD POTASSIUM DECREASED	1
C	HYPERCHOLESTEROLAEMIA	BLOOD SODIUM DECREASED	1
C	HYPERCHOLESTEROLAEMIA	CHILLS	1
C	HYPERCHOLESTEROLAEMIA	CONSTIPATION	1
C	HYPERCHOLESTEROLAEMIA	DECREASED APPETITE	1
C	HYPERCHOLESTEROLAEMIA	DIVERTICULUM	1
C	HYPERCHOLESTEROLAEMIA	DIZZINESS	1
C	HYPERCHOLESTEROLAEMIA	EAR PAIN	1
C	HYPERCHOLESTEROLAEMIA	FATIGUE	1
C	HYPERCHOLESTEROLAEMIA	GAIT DISTURBANCE	1
C	HYPERCHOLESTEROLAEMIA	HEADACHE	1
C	HYPERCHOLESTEROLAEMIA	HEPATIC ENZYME INCREASED	1
C	HYPERCHOLESTEROLAEMIA	HIATUS HERNIA	1
C	HYPERCHOLESTEROLAEMIA	HYPERTENSIVE HEART DISEASE	1
C	HYPERCHOLESTEROLAEMIA	HYPOTHYROIDISM	1
C	HYPERCHOLESTEROLAEMIA	MUSCLE ENZYME INCREASED	1
C	HYPERCHOLESTEROLAEMIA	MUSCULAR WEAKNESS	1
C	HYPERCHOLESTEROLAEMIA	MYALGIA	1
C	HYPERCHOLESTEROLAEMIA	OROPHARYNGEAL PAIN	1
C	HYPERCHOLESTEROLAEMIA	PYREXIA	1
C	HYPERCHOLESTEROLAEMIA	TONGUE DISORDER	1
C	HYPERSENSITIVITY	BLISTER	6
C	HYPERSENSITIVITY	MUSCULOSKELETAL DISORDER	1
C	HYPERSENSITIVITY	NEUROPATHY PERIPHERAL	1
C	HYPERSENSITIVITY	SKIN EXFOLIATION	6
C	HYPERSENSITIVITY	SKIN IRRITATION	6
C	HYPERSENSITIVITY	THROMBOSIS	1
C	HYPOAESTHESIA	MUSCULOSKELETAL DISORDER	1
C	HYPOAESTHESIA	NEUROPATHY PERIPHERAL	1
C	HYPOAESTHESIA	THROMBOSIS	1
C	HYPOVITAMINOSIS	MUSCULOSKELETAL DISORDER	2
C	HYPOVITAMINOSIS	NEUROPATHY PERIPHERAL	2
C	HYPOVITAMINOSIS	THROMBOSIS	2
C	INITIAL INSOMNIA	MUSCULOSKELETAL DISORDER	1
C	INITIAL INSOMNIA	NEUROPATHY PERIPHERAL	1
C	INITIAL INSOMNIA	THROMBOSIS	1
C	MULTIPLE ALLERGIES	MUSCULOSKELETAL DISORDER	1
C	MULTIPLE ALLERGIES	NEUROPATHY PERIPHERAL	1
C	MULTIPLE ALLERGIES	THROMBOSIS	1
C	NARCOLEPSY	MUSCULOSKELETAL DISORDER	1
C	NARCOLEPSY	NEUROPATHY PERIPHERAL	1
C	NARCOLEPSY	THROMBOSIS	1
C	PAIN	ABDOMINAL PAIN LOWER	1
C	PAIN	ANAEMIA	1
C	PAIN	ANGINA PECTORIS	1
C	PAIN	ASTHENIA	1
C	PAIN	BACK PAIN	1
C	PAIN	BLOOD CREATINE PHOSPHOKINASE INCREASED	1
C	PAIN	BLOOD POTASSIUM DECREASED	1
C	PAIN	BLOOD SODIUM DECREASED	1
C	PAIN	CHILLS	1
C	PAIN	CONSTIPATION	1
C	PAIN	DECREASED APPETITE	1
C	PAIN	DIVERTICULUM	1
C	PAIN	DIZZINESS	1
C	PAIN	EAR PAIN	1
C	PAIN	FATIGUE	1
C	PAIN	GAIT DISTURBANCE	1
C	PAIN	HEADACHE	1
C	PAIN	HEPATIC ENZYME INCREASED	1
C	PAIN	HIATUS HERNIA	1
C	PAIN	HYPERTENSIVE HEART DISEASE	1
C	PAIN	HYPOTHYROIDISM	1
C	PAIN	MUSCLE ENZYME INCREASED	1
C	PAIN	MUSCULAR WEAKNESS	1
C	PAIN	MUSCULOSKELETAL DISORDER	1
C	PAIN	MYALGIA	1
C	PAIN	NEUROPATHY PERIPHERAL	1
C	PAIN	OROPHARYNGEAL PAIN	1
C	PAIN	PYREXIA	1
C	PAIN	THROMBOSIS	1
C	PAIN	TONGUE DISORDER	1
C	PARAESTHESIA	MUSCULOSKELETAL DISORDER	1
C	PARAESTHESIA	NEUROPATHY PERIPHERAL	1
C	PARAESTHESIA	THROMBOSIS	1
C	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	1
C	PSYCHOMOTOR HYPERACTIVITY	MUSCULOSKELETAL DISORDER	1
C	PSYCHOMOTOR HYPERACTIVITY	NEUROPATHY PERIPHERAL	1
C	PSYCHOMOTOR HYPERACTIVITY	THROMBOSIS	1
C	PULMONARY ARTERIAL HYPERTENSION	LUNG DISORDER	1
C	PULMONARY ARTERIAL HYPERTENSION	PNEUMOTHORAX	1
C	RHEUMATOID ARTHRITIS	HYPOAESTHESIA	1
C	SLEEP DISORDER	ABDOMINAL PAIN LOWER	1
C	SLEEP DISORDER	ANAEMIA	1
C	SLEEP DISORDER	ANGINA PECTORIS	1
C	SLEEP DISORDER	ASTHENIA	1
C	SLEEP DISORDER	BACK PAIN	1
C	SLEEP DISORDER	BLOOD CREATINE PHOSPHOKINASE INCREASED	1
C	SLEEP DISORDER	BLOOD POTASSIUM DECREASED	1
C	SLEEP DISORDER	BLOOD SODIUM DECREASED	1
C	SLEEP DISORDER	CHILLS	1
C	SLEEP DISORDER	CONSTIPATION	1
C	SLEEP DISORDER	DECREASED APPETITE	1
C	SLEEP DISORDER	DIVERTICULUM	1
C	SLEEP DISORDER	DIZZINESS	1
C	SLEEP DISORDER	EAR PAIN	1
C	SLEEP DISORDER	FATIGUE	1
C	SLEEP DISORDER	GAIT DISTURBANCE	1
C	SLEEP DISORDER	HEADACHE	1
C	SLEEP DISORDER	HEPATIC ENZYME INCREASED	1
C	SLEEP DISORDER	HIATUS HERNIA	1
C	SLEEP DISORDER	HYPERTENSIVE HEART DISEASE	1
C	SLEEP DISORDER	HYPOTHYROIDISM	1
C	SLEEP DISORDER	MUSCLE ENZYME INCREASED	1
C	SLEEP DISORDER	MUSCULAR WEAKNESS	1
C	SLEEP DISORDER	MYALGIA	1
C	SLEEP DISORDER	OROPHARYNGEAL PAIN	1
C	SLEEP DISORDER	PYREXIA	1
C	SLEEP DISORDER	TONGUE DISORDER	1

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