Drug information for BENZACLIN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
GEL; TOPICAL
5%;EQ 1% BASE
Prescription
BT (Reference Drug)
BENZOYL PEROXIDE
;
CLINDAMYCIN PHOSPHATE
clindamycin phosphate benzoyl peroxide combination
SANOFI AVENTIS US
50756
2011-03-08 Letter
2011-03-07 Label
2010-06-24 Label
2010-06-18 Letter
2009-06-22 Label
2009-06-17 Letter
2007-06-04 Letter
2007-05-29 Label
2007-05-01 Letter
2007-04-25 Label
2005-05-02 Letter
2005-05-02 Label
2002-08-09 Letter
2002-08-09 Label
2000-12-21 Letter
2000-12-21 Label
2000-12-21 Review
GEL; TOPICAL
5%;EQ 1% BASE
Prescription
AB
BENZOYL PEROXIDE
;
CLINDAMYCIN PHOSPHATE
clindamycin phosphate benzoyl peroxide combination
SANOFI AVENTIS US
"
Drug Adverse Effects information for BENZACLIN
Role code
Indications
Reaction
# Reports
PS
ACNE
CANDIDIASIS
1
PS
ACNE
DIARRHOEA
1
PS
ACNE
GASTROINTESTINAL INFECTION
1
PS
ACNE
NAIL DISCOLOURATION
1
PS
ACNE
ONYCHOCLASIS
1
PS
ACNE
SKIN DISCOLOURATION
1
C
ACNE
ABDOMINAL PAIN
5
C
ACNE
ABDOMINAL PAIN LOWER
5
C
ACNE
ABDOMINAL PAIN UPPER
2
C
ACNE
ARTHRALGIA
4
C
ACNE
ARTHRITIS
1
C
ACNE
CHOLECYSTITIS ACUTE
1
C
ACNE
CHOLECYSTITIS CHRONIC
1
C
ACNE
CHOLELITHIASIS
1
C
ACNE
ERYTHEMA
5
C
ACNE
GALLBLADDER DISORDER
1
C
ACNE
GALLBLADDER INJURY
1
C
ACNE
PAIN
1
C
ACNE
PAIN IN EXTREMITY
4
C
ACNE
SYNOVIAL CYST
5
C
ACNE
TREMOR
5
C
ANAL FISTULA
ANAL FISTULA
2
C
ANAL FISTULA
CSF PROTEIN INCREASED
2
C
ANAL FISTULA
DIZZINESS
2
C
ANAL FISTULA
DYSARTHRIA
2
C
ANAL FISTULA
FALL
2
C
ANAL FISTULA
MUSCULAR WEAKNESS
2
C
ANAL FISTULA
NEUROTOXICITY
4
C
ANAL FISTULA
UNEVALUABLE EVENT
2
C
ANTICOAGULANT THERAPY
ACNE
1
C
ANTICOAGULANT THERAPY
BLOOD DISORDER
1
C
ANTICOAGULANT THERAPY
DEEP VEIN THROMBOSIS
1
C
ANTICOAGULANT THERAPY
DERMATITIS
1
C
ANTICOAGULANT THERAPY
LYMPHADENOPATHY
1
C
ANTICOAGULANT THERAPY
MENSTRUAL DISORDER
1
C
ANTICOAGULANT THERAPY
PHARYNGITIS
1
C
ANTICOAGULANT THERAPY
PULMONARY EMBOLISM
1
C
ANTICOAGULANT THERAPY
PULMONARY INFARCTION
1
C
CONTRACEPTION
ACNE
1
C
CONTRACEPTION
BLOOD DISORDER
1
C
CONTRACEPTION
DEEP VEIN THROMBOSIS
1
C
CONTRACEPTION
DERMATITIS
1
C
CONTRACEPTION
LYMPHADENOPATHY
1
C
CONTRACEPTION
MENSTRUAL DISORDER
1
C
CONTRACEPTION
PHARYNGITIS
1
C
CONTRACEPTION
PULMONARY EMBOLISM
1
C
CONTRACEPTION
PULMONARY INFARCTION
1
C
CROHN'S DISEASE
ABDOMINAL PAIN
30
C
CROHN'S DISEASE
ABDOMINAL PAIN LOWER
30
C
CROHN'S DISEASE
ABDOMINAL PAIN UPPER
6
C
CROHN'S DISEASE
ANAL FISTULA
2
C
CROHN'S DISEASE
ARTHRALGIA
24
C
CROHN'S DISEASE
ARTHRITIS
6
C
CROHN'S DISEASE
CSF PROTEIN INCREASED
2
C
CROHN'S DISEASE
DIZZINESS
2
C
CROHN'S DISEASE
DYSARTHRIA
2
C
CROHN'S DISEASE
ERYTHEMA
30
C
CROHN'S DISEASE
FALL
2
C
CROHN'S DISEASE
MUSCULAR WEAKNESS
2
C
CROHN'S DISEASE
NEUROTOXICITY
4
C
CROHN'S DISEASE
PAIN IN EXTREMITY
24
C
CROHN'S DISEASE
SYNOVIAL CYST
30
C
CROHN'S DISEASE
TREMOR
30
C
CROHN'S DISEASE
UNEVALUABLE EVENT
2
C
INFLAMMATORY BOWEL DISEASE
ANAL ABSCESS
2
C
INFLAMMATORY BOWEL DISEASE
ANAL FISTULA
1
C
INFLAMMATORY BOWEL DISEASE
CSF PROTEIN INCREASED
1
C
INFLAMMATORY BOWEL DISEASE
DIZZINESS
1
C
INFLAMMATORY BOWEL DISEASE
DYSARTHRIA
1
C
INFLAMMATORY BOWEL DISEASE
FALL
1
C
INFLAMMATORY BOWEL DISEASE
MUSCULAR WEAKNESS
1
C
INFLAMMATORY BOWEL DISEASE
NEUROTOXICITY
2
C
INFLAMMATORY BOWEL DISEASE
UNEVALUABLE EVENT
1
C
ORAL CONTRACEPTION
ABDOMINAL PAIN UPPER
2
C
ORAL CONTRACEPTION
CHOLECYSTITIS ACUTE
2
C
ORAL CONTRACEPTION
CHOLECYSTITIS CHRONIC
2
C
ORAL CONTRACEPTION
CHOLELITHIASIS
2
C
ORAL CONTRACEPTION
GALLBLADDER DISORDER
2
C
ORAL CONTRACEPTION
GALLBLADDER INJURY
2
C
ORAL CONTRACEPTION
PAIN
2
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