Drug information for LATISSE

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION/DROPS; TOPICAL	0.03%	Prescription	(Reference Drug)	BIMATOPROST	bimatoprost	ALLERGAN	22369 2012-03-29 Label 2011-09-16 Label 2011-09-12 Letter 2009-08-27 Review 2009-08-27 Summary Review 2009-01-02 Label 2008-12-31 Letter

Drug Adverse Effects information for LATISSE

Role code	Indications	Reaction	# Reports
PS	ACNE	DRUG INEFFECTIVE	1
PS	ANXIETY	HAIR GROWTH ABNORMAL	1
PS	ANXIETY	MADAROSIS	1
PS	ARTHRITIS	DRY EYE	1
PS	ARTHRITIS	EYE PAIN	1
PS	ARTHRITIS	EYELID OEDEMA	1
PS	ARTHRITIS	FOREIGN BODY SENSATION IN EYES	1
PS	ARTHRITIS	VISION BLURRED	1
PS	BLEPHARITIS	BLEPHARITIS	1
PS	BLEPHARITIS	EYELIDS PRURITUS	1
PS	BREAST CANCER	EYELIDS PRURITUS	2
PS	BREAST CANCER	FOREIGN BODY SENSATION IN EYES	2
PS	BREAST CANCER	TRICHORRHEXIS	2
PS	CYST	EYE PAIN	1
PS	CYST	OCULAR HYPERAEMIA	1
PS	CYST	VISION BLURRED	1
PS	DRY EYE	DERMATITIS CONTACT	1
PS	DRY EYE	DRUG ADMINISTERED AT INAPPROPRIATE SITE	1
PS	DRY EYE	DRUG INEFFECTIVE	1
PS	DRY EYE	DRY EYE	5
PS	DRY EYE	ERYTHEMA OF EYELID	4
PS	DRY EYE	EYELID OEDEMA	3
PS	DRY EYE	EYELID PAIN	1
PS	DRY EYE	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	3
PS	DRY EYE	MADAROSIS	1
PS	DRY EYE	OCULAR HYPERAEMIA	1
PS	DRY EYE	OFF LABEL USE	3
PS	DRY EYE	PHOTOPHOBIA	1
PS	DRY EYE	RASH	1
PS	DRY EYE	SKIN DISCOLOURATION	3
PS	DRY EYE	SKIN HYPERPIGMENTATION	1
PS	DRY EYE	THERAPEUTIC RESPONSE DECREASED	1
PS	DRY EYE	TRICHORRHEXIS	4
PS	DRY EYE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	3
PS	EYE LUBRICATION THERAPY	EYELIDS PRURITUS	1
PS	EYELASH THICKENING	DRUG INEFFECTIVE	2
PS	EYELIDS PRURITUS	BLEPHARITIS	1
PS	EYELIDS PRURITUS	EYELIDS PRURITUS	1
PS	GROWTH OF EYELASHES	ABNORMAL SENSATION IN EYE	1
PS	GROWTH OF EYELASHES	APPLICATION SITE ERYTHEMA	1
PS	GROWTH OF EYELASHES	APPLICATION SITE PRURITUS	1
PS	GROWTH OF EYELASHES	ASTHENOPIA	1
PS	GROWTH OF EYELASHES	BLEPHARITIS	3
PS	GROWTH OF EYELASHES	BLEPHAROSPASM	1
PS	GROWTH OF EYELASHES	BLISTER	1
PS	GROWTH OF EYELASHES	BLOOD PRESSURE INCREASED	1
PS	GROWTH OF EYELASHES	CATARACT	1
PS	GROWTH OF EYELASHES	CHALAZION	1
PS	GROWTH OF EYELASHES	CONJUNCTIVITIS INFECTIVE	1
PS	GROWTH OF EYELASHES	CONTUSION	1
PS	GROWTH OF EYELASHES	DARK CIRCLES UNDER EYES	1
PS	GROWTH OF EYELASHES	DERMATITIS CONTACT	1
PS	GROWTH OF EYELASHES	DRUG ADMINISTERED AT INAPPROPRIATE SITE	2
PS	GROWTH OF EYELASHES	DRUG INEFFECTIVE	29
PS	GROWTH OF EYELASHES	DRY EYE	7
PS	GROWTH OF EYELASHES	ENOPHTHALMOS	1
PS	GROWTH OF EYELASHES	ERYTHEMA	6
PS	GROWTH OF EYELASHES	ERYTHEMA OF EYELID	21
PS	GROWTH OF EYELASHES	EXPIRED DRUG ADMINISTERED	2
PS	GROWTH OF EYELASHES	EYE DISCHARGE	7
PS	GROWTH OF EYELASHES	EYE DISORDER	1
PS	GROWTH OF EYELASHES	EYE INFECTION	1
PS	GROWTH OF EYELASHES	EYE IRRITATION	10
PS	GROWTH OF EYELASHES	EYE PAIN	1
PS	GROWTH OF EYELASHES	EYE PRURITUS	14
PS	GROWTH OF EYELASHES	EYE SWELLING	3
PS	GROWTH OF EYELASHES	EYELID CYST	1
PS	GROWTH OF EYELASHES	EYELID DISORDER	1
PS	GROWTH OF EYELASHES	EYELID EXFOLIATION	2
PS	GROWTH OF EYELASHES	EYELID IRRITATION	4
PS	GROWTH OF EYELASHES	EYELID OEDEMA	11
PS	GROWTH OF EYELASHES	EYELID PAIN	4
PS	GROWTH OF EYELASHES	EYELID SKIN DRYNESS	1
PS	GROWTH OF EYELASHES	EYELIDS PRURITUS	12
PS	GROWTH OF EYELASHES	FOREIGN BODY SENSATION IN EYES	5
PS	GROWTH OF EYELASHES	GROWTH OF EYELASHES	2
PS	GROWTH OF EYELASHES	HAIR DISORDER	1
PS	GROWTH OF EYELASHES	HAIR GROWTH ABNORMAL	2
PS	GROWTH OF EYELASHES	HORDEOLUM	5
PS	GROWTH OF EYELASHES	HYPERSENSITIVITY	2
PS	GROWTH OF EYELASHES	HYPOTRICHOSIS	1
PS	GROWTH OF EYELASHES	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	7
PS	GROWTH OF EYELASHES	INCORRECT DOSE ADMINISTERED	3
PS	GROWTH OF EYELASHES	IRIS HYPERPIGMENTATION	2
PS	GROWTH OF EYELASHES	LACRIMATION INCREASED	3
PS	GROWTH OF EYELASHES	MADAROSIS	27
PS	GROWTH OF EYELASHES	MEIBOMIAN GLAND DYSFUNCTION	1
PS	GROWTH OF EYELASHES	MIOSIS	1
PS	GROWTH OF EYELASHES	MUSCLE TWITCHING	1
PS	GROWTH OF EYELASHES	OCULAR HYPERAEMIA	24
PS	GROWTH OF EYELASHES	POOR QUALITY SLEEP	1
PS	GROWTH OF EYELASHES	PRURITUS	1
PS	GROWTH OF EYELASHES	RASH	1
PS	GROWTH OF EYELASHES	RASH PUSTULAR	1
PS	GROWTH OF EYELASHES	SCAB	1
PS	GROWTH OF EYELASHES	SCLERAL HYPERAEMIA	6
PS	GROWTH OF EYELASHES	SECRETION DISCHARGE	1
PS	GROWTH OF EYELASHES	SKIN DISCOLOURATION	4
PS	GROWTH OF EYELASHES	SKIN HYPERPIGMENTATION	13
PS	GROWTH OF EYELASHES	SWELLING FACE	1
PS	GROWTH OF EYELASHES	THERAPEUTIC RESPONSE DECREASED	7
PS	GROWTH OF EYELASHES	THERAPY CESSATION	2
PS	GROWTH OF EYELASHES	TRICHIASIS	1
PS	GROWTH OF EYELASHES	TRICHORRHEXIS	13
PS	GROWTH OF EYELASHES	VISION BLURRED	1
PS	GROWTH OF EYELASHES	VISUAL ACUITY REDUCED	1
PS	GROWTH OF EYELASHES	WRONG TECHNIQUE IN DRUG USAGE PROCESS	16
PS	HAIR DISORDER	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	1
PS	HAIR DISORDER	OFF LABEL USE	1
PS	HAIR DISORDER	TRICHORRHEXIS	1
PS	HAIR DYE USER	MILIA	1
PS	HAIR GROWTH ABNORMAL	ABNORMAL SENSATION IN EYE	1
PS	HAIR GROWTH ABNORMAL	DRUG ADMINISTERED AT INAPPROPRIATE SITE	2
PS	HAIR GROWTH ABNORMAL	DRUG INEFFECTIVE	1
PS	HAIR GROWTH ABNORMAL	HAIR GROWTH ABNORMAL	1
PS	HAIR GROWTH ABNORMAL	HEADACHE	1
PS	HAIR GROWTH ABNORMAL	NECK PAIN	1
PS	HAIR GROWTH ABNORMAL	PHOTOPHOBIA	1
PS	HAIR GROWTH ABNORMAL	SKIN HYPERPIGMENTATION	1
PS	HORMONE REPLACEMENT THERAPY	MADAROSIS	1
PS	HYPERSENSITIVITY	ERYTHEMA OF EYELID	1
PS	HYPERSENSITIVITY	EYELID OEDEMA	1
PS	HYPERSENSITIVITY	EYELIDS PRURITUS	1
PS	HYPERTENSION	EYE PRURITUS	1
PS	HYPERTENSION	HAIR GROWTH ABNORMAL	1
PS	HYPERTENSION	MADAROSIS	2
PS	HYPERTENSION	MUSCLE TWITCHING	1
PS	HYPERTENSION	SKIN HYPERPIGMENTATION	1
PS	HYPERTENSION	TRICHORRHEXIS	1
PS	HYPERTENSION	VISUAL ACUITY REDUCED	1
PS	HYPOTRICHOSIS	BLEPHARITIS	1
PS	HYPOTRICHOSIS	DRUG HYPERSENSITIVITY	1
PS	HYPOTRICHOSIS	DRUG INEFFECTIVE	6
PS	HYPOTRICHOSIS	DRY EYE	3
PS	HYPOTRICHOSIS	ERYTHEMA	2
PS	HYPOTRICHOSIS	ERYTHEMA OF EYELID	6
PS	HYPOTRICHOSIS	EYE DISCHARGE	1
PS	HYPOTRICHOSIS	EYE INFECTION	1
PS	HYPOTRICHOSIS	EYE IRRITATION	3
PS	HYPOTRICHOSIS	EYE PRURITUS	4
PS	HYPOTRICHOSIS	EYE SWELLING	1
PS	HYPOTRICHOSIS	EYELID OEDEMA	1
PS	HYPOTRICHOSIS	FACE OEDEMA	1
PS	HYPOTRICHOSIS	HAIR DISORDER	2
PS	HYPOTRICHOSIS	HYPERTENSION	1
PS	HYPOTRICHOSIS	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	1
PS	HYPOTRICHOSIS	IRIS DISORDER	1
PS	HYPOTRICHOSIS	LACRIMATION INCREASED	1
PS	HYPOTRICHOSIS	MADAROSIS	3
PS	HYPOTRICHOSIS	OCULAR DISCOMFORT	1
PS	HYPOTRICHOSIS	OCULAR HYPERAEMIA	6
PS	HYPOTRICHOSIS	OFF LABEL USE	2
PS	HYPOTRICHOSIS	OPTIC NERVE INJURY	2
PS	HYPOTRICHOSIS	PRURITUS	1
PS	HYPOTRICHOSIS	RASH	1
PS	HYPOTRICHOSIS	SCLERAL HYPERAEMIA	4
PS	HYPOTRICHOSIS	SKIN DISCOLOURATION	1
PS	HYPOTRICHOSIS	SKIN EXFOLIATION	1
PS	HYPOTRICHOSIS	SKIN HYPERPIGMENTATION	2
PS	HYPOTRICHOSIS	SKIN WARM	1
PS	HYPOTRICHOSIS	SWELLING FACE	2
PS	HYPOTRICHOSIS	TRICHIASIS	1
PS	HYPOTRICHOSIS	TRICHORRHEXIS	5
PS	HYPOTRICHOSIS	VISION BLURRED	2
PS	HYPOTRICHOSIS	VISUAL ACUITY REDUCED	1
PS	HYPOTRICHOSIS	WRONG TECHNIQUE IN DRUG USAGE PROCESS	2
PS	MADAROSIS	ERYTHEMA OF EYELID	1
PS	MADAROSIS	EYE INFECTION	1
PS	MADAROSIS	EYELID OEDEMA	1
PS	MADAROSIS	EYELIDS PRURITUS	1
PS	MADAROSIS	HAIR GROWTH ABNORMAL	1
PS	MADAROSIS	IRIS DISORDER	1
PS	MADAROSIS	MADAROSIS	3
PS	MADAROSIS	OCULAR DISCOMFORT	1
PS	MADAROSIS	SCLERAL HYPERAEMIA	1
PS	MADAROSIS	SKIN DISCOLOURATION	1
PS	MADAROSIS	TRICHORRHEXIS	1
PS	MADAROSIS	VISION BLURRED	1
PS	MADAROSIS	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	OCULAR HYPERAEMIA	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	1
PS	OCULAR HYPERAEMIA	IRIS HYPERPIGMENTATION	1
PS	OFF LABEL USE	DRUG ADMINISTERED AT INAPPROPRIATE SITE	1
PS	OFF LABEL USE	DRUG INEFFECTIVE	1
PS	OFF LABEL USE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	PAIN	BLOOD PRESSURE INCREASED	1
PS	PAIN	DRUG INEFFECTIVE	1
PS	PAIN	EYE DISCHARGE	1
PS	PAIN	EYELID OEDEMA	1
PS	PAIN	LACRIMATION INCREASED	1
PS	PAIN	MADAROSIS	1
PS	PAIN	OCULAR HYPERAEMIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ABNORMAL SENSATION IN EYE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ADVERSE DRUG REACTION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ADVERSE EVENT	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ALOPECIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	APHTHOUS STOMATITIS	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	ASTHENOPIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG ADMINISTERED AT INAPPROPRIATE SITE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRY EYE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	ERYTHEMA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ERYTHEMA OF EYELID	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYE IRRITATION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYE NAEVUS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYE PAIN	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYE PRURITUS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYELID SENSORY DISORDER	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	EYELIDS PRURITUS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HAIR GROWTH ABNORMAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPERAEMIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPERSENSITIVITY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	IRIS HYPOPIGMENTATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	MADAROSIS	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	MILIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OCULAR DISCOMFORT	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OCULAR HYPERAEMIA	7
PS	PRODUCT USED FOR UNKNOWN INDICATION	ORAL DISORDER	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	PERIORBITAL OEDEMA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SCLERAL HYPERAEMIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SKIN DISCOLOURATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SKIN HYPERPIGMENTATION	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	SWOLLEN TONGUE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	THERAPEUTIC RESPONSE DECREASED	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	THERAPY CESSATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	TRICHORRHEXIS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	VISION BLURRED	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG DRUG ADMINISTERED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG TECHNIQUE IN DRUG USAGE PROCESS	6
PS	SKIN WRINKLING	DRUG INEFFECTIVE	1
PS	SLEEP DISORDER	HAIR GROWTH ABNORMAL	1
PS	SLEEP DISORDER	MADAROSIS	1
PS	THERAPEUTIC SKIN CARE TOPICAL	ASTHENOPIA	1
PS	THERAPEUTIC SKIN CARE TOPICAL	DRUG INEFFECTIVE	1
PS	THERAPEUTIC SKIN CARE TOPICAL	DRY EYE	1
PS	THERAPEUTIC SKIN CARE TOPICAL	EYELID OEDEMA	1
PS	THERAPEUTIC SKIN CARE TOPICAL	OFF LABEL USE	1
PS	THERAPEUTIC SKIN CARE TOPICAL	VISION BLURRED	2
PS	THERAPEUTIC SKIN CARE TOPICAL	VISUAL ACUITY REDUCED	1
PS	THERAPEUTIC SKIN CARE TOPICAL	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	TRICHORRHEXIS	TRICHORRHEXIS	1
SS	ACNE	DRUG INEFFECTIVE	1
SS	BREAST CANCER	EYELIDS PRURITUS	4
SS	BREAST CANCER	FOREIGN BODY SENSATION IN EYES	4
SS	BREAST CANCER	TRICHORRHEXIS	4
SS	DRY EYE	OFF LABEL USE	3
SS	DRY EYE	TRICHORRHEXIS	3
SS	EYELASH THICKENING	DRUG INEFFECTIVE	2
SS	GROWTH OF EYELASHES	APPLICATION SITE PRURITUS	1
SS	GROWTH OF EYELASHES	BLOOD PRESSURE INCREASED	1
SS	GROWTH OF EYELASHES	DRUG ADMINISTERED AT INAPPROPRIATE SITE	2
SS	GROWTH OF EYELASHES	DRUG INEFFECTIVE	6
SS	GROWTH OF EYELASHES	ERYTHEMA OF EYELID	2
SS	GROWTH OF EYELASHES	EYE DISCHARGE	2
SS	GROWTH OF EYELASHES	EYE PRURITUS	2
SS	GROWTH OF EYELASHES	EYELID OEDEMA	2
SS	GROWTH OF EYELASHES	EYELIDS PRURITUS	3
SS	GROWTH OF EYELASHES	FOREIGN BODY SENSATION IN EYES	2
SS	GROWTH OF EYELASHES	HAIR GROWTH ABNORMAL	4
SS	GROWTH OF EYELASHES	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	3
SS	GROWTH OF EYELASHES	INCORRECT DOSE ADMINISTERED	5
SS	GROWTH OF EYELASHES	LACRIMATION INCREASED	1
SS	GROWTH OF EYELASHES	MADAROSIS	8
SS	GROWTH OF EYELASHES	OCULAR HYPERAEMIA	5
SS	GROWTH OF EYELASHES	SKIN HYPERPIGMENTATION	1
SS	GROWTH OF EYELASHES	THERAPEUTIC RESPONSE DECREASED	1
SS	GROWTH OF EYELASHES	TRICHIASIS	1
SS	GROWTH OF EYELASHES	TRICHORRHEXIS	5
SS	GROWTH OF EYELASHES	WRONG TECHNIQUE IN DRUG USAGE PROCESS	4
SS	HORMONE REPLACEMENT THERAPY	MADAROSIS	1
SS	HYPOTRICHOSIS	DRUG INEFFECTIVE	2
SS	HYPOTRICHOSIS	DRY EYE	1
SS	HYPOTRICHOSIS	EYE INFECTION	1
SS	HYPOTRICHOSIS	EYE IRRITATION	1
SS	HYPOTRICHOSIS	MADAROSIS	2
SS	HYPOTRICHOSIS	OCULAR DISCOMFORT	1
SS	HYPOTRICHOSIS	OFF LABEL USE	1
SS	HYPOTRICHOSIS	SCLERAL HYPERAEMIA	2
SS	HYPOTRICHOSIS	SKIN HYPERPIGMENTATION	1
SS	HYPOTRICHOSIS	TRICHORRHEXIS	1
SS	HYPOTRICHOSIS	VISION BLURRED	1
SS	MADAROSIS	EYE INFECTION	1
SS	MADAROSIS	OCULAR DISCOMFORT	1
SS	MADAROSIS	SCLERAL HYPERAEMIA	1
SS	MADAROSIS	VISION BLURRED	1
SS	OFF LABEL USE	DRUG ADMINISTERED AT INAPPROPRIATE SITE	2
SS	OFF LABEL USE	DRUG INEFFECTIVE	2
SS	OFF LABEL USE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	2
SS	PAIN	BLOOD PRESSURE INCREASED	1
SS	PAIN	DRUG INEFFECTIVE	1
SS	PAIN	EYE DISCHARGE	1
SS	PAIN	EYELID OEDEMA	1
SS	PAIN	LACRIMATION INCREASED	1
SS	PAIN	MADAROSIS	1
SS	PAIN	OCULAR HYPERAEMIA	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	MADAROSIS	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	OCULAR DISCOMFORT	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	SCLERAL HYPERAEMIA	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	VISION BLURRED	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
SS	SKIN WRINKLING	DRUG INEFFECTIVE	1

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