Drug information for EPIDUO
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
GEL; TOPICAL
0.1%;2.5%
Prescription
(Reference Drug)
ADAPALENE
;
BENZOYL PEROXIDE
adapalene
GALDERMA LABS LP
22320
2011-12-20 Label
2011-12-20 Letter
2011-02-24 Label
2011-02-24 Letter
2010-01-13 Review
2010-01-13 Summary Review
2009-01-02 Label
2008-12-19 Letter
Drug Adverse Effects information for EPIDUO
Role code
Indications
Reaction
# Reports
PS
ACNE
APPLICATION SITE ERYTHEMA
1
PS
ACNE
APPLICATION SITE EXFOLIATION
1
PS
ACNE
APPLICATION SITE PAIN
1
PS
ACNE
APPLICATION SITE PRURITUS
1
PS
ACNE
ARTHRALGIA
2
PS
ACNE
ERYTHEMA
2
PS
ACNE
EYE OEDEMA
2
PS
ACNE
JOINT SWELLING
1
PS
ACNE
LUPUS-LIKE SYNDROME
2
PS
ACNE
LYMPHADENOPATHY
1
PS
ACNE
PARALYSIS
1
PS
ACNE
PRURITUS
2
PS
ACNE
PYREXIA
1
PS
ACNE
RASH
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FALLOT'S TETRALOGY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MATERNAL DRUGS AFFECTING FOETUS
1
SS
MATERNAL EXPOSURE DURING PREGNANCY
FOETAL MONITORING ABNORMAL
2
SS
MATERNAL EXPOSURE DURING PREGNANCY
MATERNAL DRUGS AFFECTING FOETUS
2
SS
MATERNAL EXPOSURE DURING PREGNANCY
VACUUM EXTRACTOR DELIVERY
2
C
ACNE
HEPATOTOXICITY
1
C
INFLAMMATORY BOWEL DISEASE
ABDOMINAL PAIN
4
C
MULTIPLE SCLEROSIS
HEPATOTOXICITY
1
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