Drug information for FACTIVE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
EQ 320MG BASE
Prescription
(Reference Drug)
GEMIFLOXACIN MESYLATE
gemifloxacin
CORNERSTONE THERAP
21158
2011-10-20 Label
2011-10-20 Letter
2011-03-04 Label
2011-03-03 Letter
2009-11-19 Medication Guide
2009-05-15 Other
2009-05-11 Label
2009-05-04 Letter
2009-04-03 Label
2008-10-09 Label
2008-10-08 Letter
2008-01-09 Letter
2007-05-07 Letter
2007-05-07 Label
2006-11-06 Letter
2006-10-27 Label
2004-09-10 Label
2004-09-10 Letter
2004-07-30 Label
2004-07-30 Letter
2003-09-24 Review
2003-08-15 Letter
2003-08-15 Label
2003-04-18 Letter
2003-04-04 Label
Drug Adverse Effects information for FACTIVE
Role code
Indications
Reaction
# Reports
PS
BRONCHITIS
NO THERAPEUTIC RESPONSE
1
PS
BRONCHITIS
OEDEMA
1
PS
BRONCHITIS
RASH
2
PS
BRONCHITIS
URTICARIA
1
PS
SINUSITIS
FEELING JITTERY
1
PS
SINUSITIS
GASTRIC DISORDER
1
PS
SINUSITIS
INSOMNIA
1
PS
SINUSITIS
NAUSEA
1
PS
SINUSITIS
NIGHT SWEATS
1
PS
SINUSITIS
PAIN
1
PS
SINUSITIS
PRURITUS
1
PS
SINUSITIS
RASH
1
PS
SINUSITIS
SINUSITIS
1
PS
SINUSITIS
URTICARIA
1
C
COUGH
DRUG HYPERSENSITIVITY
6
C
COUGH
SWELLING
6
C
FEMALE STERILISATION
ANXIETY
2
C
FEMALE STERILISATION
DEEP VEIN THROMBOSIS
2
C
FEMALE STERILISATION
DEPRESSION
2
C
FEMALE STERILISATION
EMOTIONAL DISTRESS
2
C
FEMALE STERILISATION
FEAR
2
C
FEMALE STERILISATION
PAIN IN EXTREMITY
2
C
HYPERSENSITIVITY
ANXIETY
1
C
HYPERSENSITIVITY
DEEP VEIN THROMBOSIS
1
C
HYPERSENSITIVITY
DEPRESSION
1
C
HYPERSENSITIVITY
EMOTIONAL DISTRESS
1
C
HYPERSENSITIVITY
FEAR
1
C
HYPERSENSITIVITY
PAIN IN EXTREMITY
1
C
PAIN
ANXIETY
1
C
PAIN
DEEP VEIN THROMBOSIS
1
C
PAIN
DEPRESSION
1
C
PAIN
DRUG HYPERSENSITIVITY
2
C
PAIN
EMOTIONAL DISTRESS
1
C
PAIN
FEAR
1
C
PAIN
PAIN IN EXTREMITY
1
C
PAIN
SWELLING
2
C
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
1
C
PRODUCT USED FOR UNKNOWN INDICATION
DEEP VEIN THROMBOSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
EMOTIONAL DISTRESS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FEAR
1
C
PRODUCT USED FOR UNKNOWN INDICATION
PAIN IN EXTREMITY
1
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