Drug information for SARAFEM
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
EQ 10MG BASE
Prescription
AB2
FLUOXETINE HYDROCHLORIDE
Fluoxetine
LILLY
18936
2011-06-16 Label
2011-06-16 Letter
2011-06-15 Medication Guide
2011-06-15 Medication Guide
2011-06-15 Medication Guide
2011-04-13 Letter
2011-04-13 Letter
2011-04-13 Letter
2011-04-04 Label
2011-04-04 Label
2011-04-04 Label
2009-11-20 Medication Guide
2009-06-24 Label
2009-06-24 Letter
2009-03-24 Letter
2009-03-24 Letter
2009-03-20 Label
2009-03-20 Label
2009-02-04 Label
2009-02-03 Letter
2008-07-01 Letter
2008-06-30 Label
2008-03-24 Letter
2008-03-24 Label
2008-03-13 Label
2008-03-12 Letter
2007-12-06 Review
2007-08-07 Letter
2007-08-07 Letter
2007-08-03 Label
2007-08-03 Label
2007-03-23 Letter
2007-02-20 Review
2007-02-20 Review
2007-02-20 Review
2006-09-21 Label
2006-04-13 Letter
2005-12-05 Letter
2005-12-05 Letter
2005-08-01 Other Important Information from FDA
2005-02-23 Letter
2004-09-03 Letter
2004-08-25 Letter
2004-08-09 Review
2004-08-09 Review
2003-09-25 Review
2003-09-25 Review
2003-01-07 Label
2003-01-07 Letter
2002-07-29 Label
2002-06-12 Label
2002-06-12 Letter
2000-07-06 Letter
2000-07-06 Label
CAPSULE; ORAL
EQ 20MG BASE
Prescription
AB2 (Reference Drug)
FLUOXETINE HYDROCHLORIDE
Fluoxetine
LILLY
"
TABLET; ORAL
EQ 10MG BASE
Prescription
FLUOXETINE HYDROCHLORIDE
Fluoxetine
WARNER CHILCOTT
21860
2010-12-03 Medication Guide
2009-04-28 Label
2009-04-27 Letter
2008-09-05 Review
2007-12-03 Letter
2007-12-03 Label
2007-05-09 Other Important Information from FDA
2007-04-09 Letter
2007-04-09 Label
2006-05-22 Label
2006-05-22 Letter
TABLET; ORAL
EQ 15MG BASE
Prescription
FLUOXETINE HYDROCHLORIDE
Fluoxetine
WARNER CHILCOTT
"
TABLET; ORAL
EQ 20MG BASE
Prescription
(Reference Drug)
FLUOXETINE HYDROCHLORIDE
Fluoxetine
WARNER CHILCOTT
"
Drug Adverse Effects information for SARAFEM
Role code
Indications
Reaction
# Reports
C
ANTICOAGULANT THERAPY
ANHEDONIA
1
C
ANTICOAGULANT THERAPY
ARTHRALGIA
1
C
ANTICOAGULANT THERAPY
CHOLECYSTITIS CHRONIC
1
C
ANTICOAGULANT THERAPY
DEEP VEIN THROMBOSIS
1
C
ANTICOAGULANT THERAPY
EMOTIONAL DISTRESS
1
C
ANTICOAGULANT THERAPY
ERYTHEMA
1
C
ANTICOAGULANT THERAPY
HYPOAESTHESIA
1
C
ANTICOAGULANT THERAPY
LIMB DISCOMFORT
1
C
ANTICOAGULANT THERAPY
MUSCLE SPASMS
1
C
ANTICOAGULANT THERAPY
OEDEMA PERIPHERAL
1
C
ANTICOAGULANT THERAPY
POOR PERIPHERAL CIRCULATION
1
C
ANTICOAGULANT THERAPY
TENDERNESS
1
C
ANTICOAGULANT THERAPY
THROMBOPHLEBITIS SUPERFICIAL
1
C
ASTHMA
ANHEDONIA
1
C
ASTHMA
ARTHRALGIA
1
C
ASTHMA
CHOLECYSTITIS CHRONIC
1
C
ASTHMA
DEEP VEIN THROMBOSIS
1
C
ASTHMA
EMOTIONAL DISTRESS
1
C
ASTHMA
ERYTHEMA
1
C
ASTHMA
HYPOAESTHESIA
1
C
ASTHMA
LIMB DISCOMFORT
1
C
ASTHMA
MUSCLE SPASMS
1
C
ASTHMA
OEDEMA PERIPHERAL
1
C
ASTHMA
POOR PERIPHERAL CIRCULATION
1
C
ASTHMA
TENDERNESS
1
C
ASTHMA
THROMBOPHLEBITIS SUPERFICIAL
1
C
CONTRACEPTION
ADRENAL INSUFFICIENCY
1
C
CONTRACEPTION
BILIARY DYSKINESIA
1
C
CONTRACEPTION
CHOLECYSTITIS
2
C
CONTRACEPTION
CHOLECYSTITIS CHRONIC
1
C
CONTRACEPTION
DEPRESSION
1
C
CONTRACEPTION
FLUID RETENTION
1
C
CONTRACEPTION
GALLBLADDER DISORDER
3
C
CONTRACEPTION
HYPERTENSION
1
C
CONTRACEPTION
LYMPHOMA
1
C
CONTRACEPTION
NON-HODGKIN'S LYMPHOMA
1
C
CONTRACEPTION
PAIN
2
C
CONTRACEPTION
PALPITATIONS
1
C
CONTRACEPTION
STRESS
1
C
DYSMENORRHOEA
CALCULUS URETERIC
2
C
DYSMENORRHOEA
INJURY
2
C
DYSMENORRHOEA
NEPHROLITHIASIS
2
C
DYSMENORRHOEA
PAIN
2
C
DYSPEPSIA
CHOLECYSTITIS
2
C
DYSPEPSIA
DYSPNOEA
2
C
DYSPEPSIA
PAIN
2
C
DYSPEPSIA
VOMITING
2
C
DYSPEPSIA
VOMITING PSYCHOGENIC
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
ANHEDONIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
ARTHRALGIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
CHOLECYSTITIS CHRONIC
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DEEP VEIN THROMBOSIS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
EMOTIONAL DISTRESS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
ERYTHEMA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
HYPOAESTHESIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
LIMB DISCOMFORT
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
MUSCLE SPASMS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
OEDEMA PERIPHERAL
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
POOR PERIPHERAL CIRCULATION
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
TENDERNESS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
THROMBOPHLEBITIS SUPERFICIAL
1
C
MENSTRUAL CYCLE MANAGEMENT
ADRENAL INSUFFICIENCY
1
C
MENSTRUAL CYCLE MANAGEMENT
BILIARY DYSKINESIA
1
C
MENSTRUAL CYCLE MANAGEMENT
CHOLECYSTITIS
2
C
MENSTRUAL CYCLE MANAGEMENT
CHOLECYSTITIS CHRONIC
1
C
MENSTRUAL CYCLE MANAGEMENT
DEPRESSION
1
C
MENSTRUAL CYCLE MANAGEMENT
DYSPNOEA
2
C
MENSTRUAL CYCLE MANAGEMENT
FLUID RETENTION
1
C
MENSTRUAL CYCLE MANAGEMENT
GALLBLADDER DISORDER
1
C
MENSTRUAL CYCLE MANAGEMENT
HYPERTENSION
1
C
MENSTRUAL CYCLE MANAGEMENT
LYMPHOMA
1
C
MENSTRUAL CYCLE MANAGEMENT
NON-HODGKIN'S LYMPHOMA
1
C
MENSTRUAL CYCLE MANAGEMENT
PAIN
2
C
MENSTRUAL CYCLE MANAGEMENT
PALPITATIONS
1
C
MENSTRUAL CYCLE MANAGEMENT
STRESS
1
C
MENSTRUAL CYCLE MANAGEMENT
VOMITING
2
C
MENSTRUAL CYCLE MANAGEMENT
VOMITING PSYCHOGENIC
2
C
MIGRAINE
CHOLECYSTITIS
1
C
MIGRAINE
GALLBLADDER DISORDER
1
C
MIGRAINE
PAIN
1
C
MULTIPLE ALLERGIES
ANHEDONIA
1
C
MULTIPLE ALLERGIES
ARTHRALGIA
1
C
MULTIPLE ALLERGIES
CHOLECYSTITIS CHRONIC
1
C
MULTIPLE ALLERGIES
DEEP VEIN THROMBOSIS
1
C
MULTIPLE ALLERGIES
EMOTIONAL DISTRESS
1
C
MULTIPLE ALLERGIES
ERYTHEMA
1
C
MULTIPLE ALLERGIES
HYPOAESTHESIA
1
C
MULTIPLE ALLERGIES
LIMB DISCOMFORT
1
C
MULTIPLE ALLERGIES
MUSCLE SPASMS
1
C
MULTIPLE ALLERGIES
OEDEMA PERIPHERAL
1
C
MULTIPLE ALLERGIES
POOR PERIPHERAL CIRCULATION
1
C
MULTIPLE ALLERGIES
TENDERNESS
1
C
MULTIPLE ALLERGIES
THROMBOPHLEBITIS SUPERFICIAL
1
C
PAIN MANAGEMENT
ANHEDONIA
1
C
PAIN MANAGEMENT
ARTHRALGIA
1
C
PAIN MANAGEMENT
CHOLECYSTITIS CHRONIC
1
C
PAIN MANAGEMENT
DEEP VEIN THROMBOSIS
1
C
PAIN MANAGEMENT
EMOTIONAL DISTRESS
1
C
PAIN MANAGEMENT
ERYTHEMA
1
C
PAIN MANAGEMENT
HYPOAESTHESIA
1
C
PAIN MANAGEMENT
LIMB DISCOMFORT
1
C
PAIN MANAGEMENT
MUSCLE SPASMS
1
C
PAIN MANAGEMENT
OEDEMA PERIPHERAL
1
C
PAIN MANAGEMENT
POOR PERIPHERAL CIRCULATION
1
C
PAIN MANAGEMENT
TENDERNESS
1
C
PAIN MANAGEMENT
THROMBOPHLEBITIS SUPERFICIAL
1
C
PREMENSTRUAL SYNDROME
ANGER
2
C
PREMENSTRUAL SYNDROME
ANHEDONIA
2
C
PREMENSTRUAL SYNDROME
ANXIETY
2
C
PREMENSTRUAL SYNDROME
ARTHRALGIA
2
C
PREMENSTRUAL SYNDROME
CALCULUS URETERIC
2
C
PREMENSTRUAL SYNDROME
CHOLECYSTITIS
2
C
PREMENSTRUAL SYNDROME
CHOLECYSTITIS CHRONIC
2
C
PREMENSTRUAL SYNDROME
DEEP VEIN THROMBOSIS
4
C
PREMENSTRUAL SYNDROME
DEPRESSION
2
C
PREMENSTRUAL SYNDROME
DYSPNOEA
2
C
PREMENSTRUAL SYNDROME
EMOTIONAL DISTRESS
2
C
PREMENSTRUAL SYNDROME
ERYTHEMA
2
C
PREMENSTRUAL SYNDROME
GAIT DISTURBANCE
2
C
PREMENSTRUAL SYNDROME
HYPOAESTHESIA
2
C
PREMENSTRUAL SYNDROME
INJURY
2
C
PREMENSTRUAL SYNDROME
IRRITABILITY
2
C
PREMENSTRUAL SYNDROME
LIMB DISCOMFORT
2
C
PREMENSTRUAL SYNDROME
MUSCLE SPASMS
2
C
PREMENSTRUAL SYNDROME
NEPHROLITHIASIS
2
C
PREMENSTRUAL SYNDROME
OEDEMA PERIPHERAL
4
C
PREMENSTRUAL SYNDROME
PAIN
4
C
PREMENSTRUAL SYNDROME
PAIN IN EXTREMITY
2
C
PREMENSTRUAL SYNDROME
POOR PERIPHERAL CIRCULATION
2
C
PREMENSTRUAL SYNDROME
TENDERNESS
2
C
PREMENSTRUAL SYNDROME
THROMBOPHLEBITIS SUPERFICIAL
2
C
PREMENSTRUAL SYNDROME
VOMITING
2
C
PREMENSTRUAL SYNDROME
VOMITING PSYCHOGENIC
2
C
SINUS HEADACHE
CALCULUS URETERIC
1
C
SINUS HEADACHE
INJURY
1
C
SINUS HEADACHE
NEPHROLITHIASIS
1
C
SINUS HEADACHE
PAIN
1
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