Drug information for ACZONE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
GEL; TOPICAL
5%
Prescription
(Reference Drug)
DAPSONE
Dapsone
ALLERGAN
21794
2009-04-03 Label
2008-03-18 Letter
2008-03-17 Label
2007-09-13 Review
2005-07-15 Letter
2005-07-08 Label
Drug Adverse Effects information for ACZONE
Role code
Indications
Reaction
# Reports
PS
ACNE
ACNE
6
PS
ACNE
ALLERGY TO ARTHROPOD BITE
1
PS
ACNE
APPLICATION SITE DISCOLOURATION
2
PS
ACNE
BURNING SENSATION
1
PS
ACNE
DRUG INEFFECTIVE
17
PS
ACNE
DRY SKIN
1
PS
ACNE
ERYTHEMA
2
PS
ACNE
NAUSEA
1
PS
ACNE
PARAESTHESIA
1
PS
ACNE
PHOTOSENSITIVITY REACTION
1
PS
ACNE
PRURITUS
1
PS
ACNE
RASH
4
PS
ACNE
SEBORRHOEA
1
PS
ACNE
SECRETION DISCHARGE
1
PS
ACNE
SKIN EXFOLIATION
1
PS
ACNE
SKIN IRRITATION
1
PS
ACNE
THERAPEUTIC RESPONSE DECREASED
1
PS
ACNE
VOMITING
1
PS
DIABETES MELLITUS
NAUSEA
1
PS
DIABETES MELLITUS
VOMITING
1
PS
ECZEMA
ERYTHEMA
1
PS
FIBROMYALGIA
NAUSEA
1
PS
FIBROMYALGIA
VOMITING
1
PS
HYPERTENSION
NAUSEA
1
PS
HYPERTENSION
VOMITING
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ALLERGY TO ARTHROPOD BITE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BURNING SENSATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
COMPLETED SUICIDE
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INEFFECTIVE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRY SKIN
1
PS
ROSACEA
ERYTHEMA
1
PS
ROSACEA
NAUSEA
1
PS
ROSACEA
VOMITING
1
SS
ACNE
PARAESTHESIA
1
SS
ECZEMA
ERYTHEMA
1
SS
ROSACEA
ERYTHEMA
1
C
ACNE
BURNING SENSATION
1
C
ACNE
PAIN
1
C
ACNE
PRURITUS
1
C
ACNE
RASH MACULAR
1
C
ACNE
SKIN EXFOLIATION
1
C
DIABETES MELLITUS
NAUSEA
1
C
DIABETES MELLITUS
VOMITING
1
C
FIBROMYALGIA
NAUSEA
2
C
FIBROMYALGIA
VOMITING
2
C
HYPERTENSION
NAUSEA
1
C
HYPERTENSION
VOMITING
1
C
ROSACEA
NAUSEA
1
C
ROSACEA
VOMITING
1
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