Drug information for DUAC

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 STIEFEL 50741
2011-12-28 Letter
2011-12-23 Label
2010-11-10 Letter
2010-11-08 Label
2008-07-24 Letter
2008-07-23 Label
2003-12-02 Label
2003-11-25 Letter
2003-10-27 Label
2003-10-24 Letter
2003-04-28 Review
2003-04-28 Letter
2003-04-28 Label

Drug Adverse Effects information for DUAC

Role code Indications Reaction # Reports
PS ACNE ABDOMINAL DISCOMFORT 1
PS ACNE ACNE 2
PS ACNE APPLICATION SITE REACTION 2
PS ACNE BLISTER 2
PS ACNE BURNING SENSATION 3
PS ACNE DERMATITIS CONTACT 1
PS ACNE DIARRHOEA 1
PS ACNE DISCOMFORT 1
PS ACNE DRUG ADMINISTRATION ERROR 1
PS ACNE DRUG INEFFECTIVE 4
PS ACNE DRY SKIN 5
PS ACNE DYSGEUSIA 1
PS ACNE ENERGY INCREASED 1
PS ACNE EPHELIDES 1
PS ACNE ERYTHEMA 12
PS ACNE EXPIRED DRUG ADMINISTERED 1
PS ACNE EYE SWELLING 2
PS ACNE EYELIDS PRURITUS 1
PS ACNE FACIAL PAIN 1
PS ACNE HYPERSENSITIVITY 1
PS ACNE ILL-DEFINED DISORDER 4
PS ACNE INFLAMMATION 1
PS ACNE LIP SWELLING 1
PS ACNE PAIN 1
PS ACNE PENILE EXFOLIATION 1
PS ACNE PENIS DISORDER 1
PS ACNE PIGMENTATION DISORDER 1
PS ACNE PRODUCT QUALITY ISSUE 2
PS ACNE PRURITUS 10
PS ACNE RASH 1
PS ACNE RASH MACULAR 2
PS ACNE SKIN BURNING SENSATION 1
PS ACNE SKIN EXFOLIATION 2
PS ACNE SKIN IRRITATION 2
PS ACNE SWELLING FACE 2
PS ACNE THERMAL BURN 1
PS ACNE TOXIC SKIN ERUPTION 2
PS ACNE URTICARIA 3
PS ACNE VISUAL IMPAIRMENT 1
PS ACNE VULVOVAGINAL MYCOTIC INFECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE IRRITATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION ILL-DEFINED DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 2
PS PRODUCT USED FOR UNKNOWN INDICATION SUNBURN 1
PS RASH DRUG INEFFECTIVE 1
PS RASH PRODUCT QUALITY ISSUE 1
C ACNE ANAL ABSCESS 5
C ACNE ANAL FISTULA 5
C ACNE BLOOD CHOLESTEROL INCREASED 1
C ACNE BLOOD TRIGLYCERIDES INCREASED 5
C ACNE CHAPPED LIPS 1
C ACNE CHOLECYSTITIS CHRONIC 1
C ACNE COLITIS ULCERATIVE 11
C ACNE CROHN'S DISEASE 6
C ACNE DEEP VEIN THROMBOSIS 8
C ACNE DEPRESSION 7
C ACNE DRY EYE 5
C ACNE FATIGUE 5
C ACNE GALLBLADDER DISORDER 1
C ACNE HEADACHE 5
C ACNE INFLAMMATORY BOWEL DISEASE 16
C ACNE INTESTINAL HAEMORRHAGE 10
C ACNE IRRITABLE BOWEL SYNDROME 10
C ACNE LIP DRY 5
C ACNE LIVER FUNCTION TEST ABNORMAL 5
C ACNE OEDEMA PERIPHERAL 8
C ACNE ORAL HERPES 5
C ACNE PAIN 1
C ACNE PARONYCHIA 1
C ACNE POLYP 5
C ACNE PROTEINURIA 1
C ACNE SMALL INTESTINAL OBSTRUCTION 5
C ACNE SUICIDAL IDEATION 1
C ACNE VASCULAR COMPRESSION 8
C ASTHMA PULMONARY EMBOLISM 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION COLITIS ULCERATIVE 4
C CONTRACEPTION DEPRESSION 1
C CONTRACEPTION GALLBLADDER DISORDER 1
C CONTRACEPTION INFLAMMATORY BOWEL DISEASE 4
C CONTRACEPTION INTESTINAL HAEMORRHAGE 4
C CONTRACEPTION IRRITABLE BOWEL SYNDROME 4
C CONTRACEPTION PAIN 1
C COUGH DEEP VEIN THROMBOSIS 4
C COUGH OEDEMA PERIPHERAL 4
C COUGH VASCULAR COMPRESSION 4
C MENSTRUATION IRREGULAR DEEP VEIN THROMBOSIS 2
C MENSTRUATION IRREGULAR OEDEMA PERIPHERAL 2
C MENSTRUATION IRREGULAR VASCULAR COMPRESSION 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 1
C PREMENSTRUAL SYNDROME DEPRESSION 1
C PREMENSTRUAL SYNDROME GALLBLADDER DISORDER 1
C PREMENSTRUAL SYNDROME PAIN 1
C PREMENSTRUAL SYNDROME PULMONARY EMBOLISM 1
C WHEEZING PULMONARY EMBOLISM 1
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