Drug information for FML

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
OINTMENT; OPHTHALMIC 0.1% Prescription  (Reference Drug) FLUOROMETHOLONE Fluorometholone ALLERGAN 17760
2007-09-25 Letter
2003-06-16 Label
2001-07-13 Letter
SUSPENSION/DROPS; OPHTHALMIC 0.1% Prescription  (Reference Drug) FLUOROMETHOLONE Fluorometholone ALLERGAN 16851
2003-06-16 Label
2001-06-28 Letter

Drug Adverse Effects information for FML

Role code Indications Reaction # Reports
PS BLEPHARITIS CUTIS LAXA 2
PS BLEPHARITIS PERIORBITAL OEDEMA 2
PS DRY EYE DIZZINESS 1
PS DRY EYE HEADACHE 1
PS EYE INFECTION DIZZINESS 1
PS EYE INFECTION HEADACHE 1
PS HERPES ZOSTER OPHTHALMIC LACRIMATION INCREASED 1
PS SWELLING FACE VISION BLURRED 1
C BLOOD PRESSURE MANAGEMENT ANXIETY 2
C BLOOD PRESSURE MANAGEMENT CHOLECYSTITIS 1
C BLOOD PRESSURE MANAGEMENT CHOLECYSTITIS CHRONIC 1
C BLOOD PRESSURE MANAGEMENT EMOTIONAL DISORDER 2
C BLOOD PRESSURE MANAGEMENT FEAR 2
C BLOOD PRESSURE MANAGEMENT INJURY 2
C BLOOD PRESSURE MANAGEMENT PAIN 2
C CONTRACEPTION ANXIETY 2
C CONTRACEPTION CHOLECYSTITIS 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION EMOTIONAL DISORDER 2
C CONTRACEPTION FEAR 2
C CONTRACEPTION INJURY 2
C CONTRACEPTION PAIN 2
C GENERAL PHYSICAL HEALTH DETERIORATION ANXIETY 1
C GENERAL PHYSICAL HEALTH DETERIORATION CHOLECYSTITIS CHRONIC 1
C GENERAL PHYSICAL HEALTH DETERIORATION EMOTIONAL DISORDER 1
C GENERAL PHYSICAL HEALTH DETERIORATION FEAR 1
C GENERAL PHYSICAL HEALTH DETERIORATION INJURY 1
C GENERAL PHYSICAL HEALTH DETERIORATION PAIN 1
C HYPERTENSION ANXIETY 2
C HYPERTENSION CHOLECYSTITIS 1
C HYPERTENSION CHOLECYSTITIS CHRONIC 1
C HYPERTENSION EMOTIONAL DISORDER 2
C HYPERTENSION FEAR 2
C HYPERTENSION INJURY 2
C HYPERTENSION PAIN 2
C INSOMNIA ANXIETY 2
C INSOMNIA CHOLECYSTITIS 1
C INSOMNIA CHOLECYSTITIS CHRONIC 1
C INSOMNIA EMOTIONAL DISORDER 2
C INSOMNIA FEAR 2
C INSOMNIA INJURY 2
C INSOMNIA PAIN 2
C UNEVALUABLE EVENT ANXIETY 1
C UNEVALUABLE EVENT CHOLECYSTITIS 1
C UNEVALUABLE EVENT EMOTIONAL DISORDER 1
C UNEVALUABLE EVENT FEAR 1
C UNEVALUABLE EVENT INJURY 1
C UNEVALUABLE EVENT PAIN 1
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