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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