Drug information for FINACEA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
GEL; TOPICAL 15% Prescription  (Reference Drug) AZELAIC ACID azelaic acid INTENDIS 21470
2010-11-03 Letter

2010-10-25 Label

2005-05-17 Letter

2005-05-17 Label

2004-06-04 Letter

2004-03-24 Review

2002-12-24 Label

Drug Adverse Effects information for FINACEA

Role code Indications Reaction # Reports
PS ACNE HYPERTRICHOSIS 1
PS ACNE PIGMENTATION DISORDER 1
PS ACNE SKIN BURNING SENSATION 1
PS ACNE SKIN DISCOLOURATION 1
PS DIABETES MELLITUS NAUSEA 1
PS DIABETES MELLITUS VOMITING 1
PS FIBROMYALGIA NAUSEA 2
PS FIBROMYALGIA VOMITING 2
PS HYPERTENSION NAUSEA 1
PS HYPERTENSION VOMITING 1
PS ROSACEA BURNING SENSATION 2
PS ROSACEA DERMATITIS ALLERGIC 1
PS ROSACEA HYPERTRICHOSIS 1
PS ROSACEA NAUSEA 1
PS ROSACEA OEDEMA 1
PS ROSACEA PAIN 1
PS ROSACEA PARAESTHESIA 1
PS ROSACEA RASH 1
PS ROSACEA RASH MACULO-PAPULAR 1
PS ROSACEA ROSACEA 2
PS ROSACEA SKIN BURNING SENSATION 1
PS ROSACEA SKIN EXFOLIATION 1
PS ROSACEA SWELLING FACE 1
PS ROSACEA URTICARIA 1
PS ROSACEA VOMITING 1
SS ACNE HYPERTRICHOSIS 1
SS ROSACEA HYPERTRICHOSIS 1
SS ROSACEA PARAESTHESIA 1
SS ROSACEA ROSACEA 1
C ACNE NAUSEA 1
C ACNE VOMITING 1
C CARDIAC DISORDER MALAISE 1
C CARDIAC DISORDER VOMITING 1
C DIABETES MELLITUS NAUSEA 1
C DIABETES MELLITUS VOMITING 1
C FIBROMYALGIA NAUSEA 1
C FIBROMYALGIA VOMITING 1
C HEART RATE IRREGULAR ABDOMINAL DISCOMFORT 1
C HEART RATE IRREGULAR ABDOMINAL PAIN UPPER 1
C HEART RATE IRREGULAR ADDISON'S DISEASE 1
C HEART RATE IRREGULAR ANAEMIA 1
C HEART RATE IRREGULAR ANHEDONIA 1
C HEART RATE IRREGULAR ANXIETY 1
C HEART RATE IRREGULAR APHAGIA 1
C HEART RATE IRREGULAR ASTHENIA 1
C HEART RATE IRREGULAR BALANCE DISORDER 1
C HEART RATE IRREGULAR BLOOD BILIRUBIN INCREASED 1
C HEART RATE IRREGULAR BLOOD GLUCOSE FLUCTUATION 1
C HEART RATE IRREGULAR BLOOD GLUCOSE INCREASED 1
C HEART RATE IRREGULAR BLOOD PRESSURE INCREASED 1
C HEART RATE IRREGULAR CHEST DISCOMFORT 1
C HEART RATE IRREGULAR CHOLELITHIASIS 1
C HEART RATE IRREGULAR DECREASED APPETITE 1
C HEART RATE IRREGULAR DEHYDRATION 1
C HEART RATE IRREGULAR DIARRHOEA 1
C HEART RATE IRREGULAR ECONOMIC PROBLEM 1
C HEART RATE IRREGULAR EJECTION FRACTION DECREASED 1
C HEART RATE IRREGULAR ELECTROCARDIOGRAM ST SEGMENT ABNORMAL 1
C HEART RATE IRREGULAR ELECTROCARDIOGRAM ST-T CHANGE 1
C HEART RATE IRREGULAR EMOTIONAL DISORDER 1
C HEART RATE IRREGULAR ERUCTATION 1
C HEART RATE IRREGULAR FATIGUE 1
C HEART RATE IRREGULAR GASTRODUODENITIS 1
C HEART RATE IRREGULAR GLOMERULAR FILTRATION RATE DECREASED 1
C HEART RATE IRREGULAR HEART RATE INCREASED 1
C HEART RATE IRREGULAR HYPERKALAEMIA 1
C HEART RATE IRREGULAR HYPOMAGNESAEMIA 1
C HEART RATE IRREGULAR HYPONATRAEMIA 1
C HEART RATE IRREGULAR LARYNGITIS 1
C HEART RATE IRREGULAR MENTAL DISORDER 1
C HEART RATE IRREGULAR MITRAL VALVE INCOMPETENCE 1
C HEART RATE IRREGULAR MULTIPLE INJURIES 1
C HEART RATE IRREGULAR MYOCARDIAL ISCHAEMIA 1
C HEART RATE IRREGULAR NAUSEA 1
C HEART RATE IRREGULAR NOCTURIA 1
C HEART RATE IRREGULAR OROPHARYNGEAL PAIN 1
C HEART RATE IRREGULAR PAIN 1
C HEART RATE IRREGULAR PALPITATIONS 1
C HEART RATE IRREGULAR PULMONARY HYPERTENSION 1
C HEART RATE IRREGULAR PULMONARY VALVE INCOMPETENCE 1
C HEART RATE IRREGULAR RENAL CYST 1
C HEART RATE IRREGULAR SINUS TACHYCARDIA 1
C HEART RATE IRREGULAR TOXICITY TO VARIOUS AGENTS 1
C HEART RATE IRREGULAR TRICUSPID VALVE INCOMPETENCE 1
C HEART RATE IRREGULAR URINARY TRACT INFECTION 1
C HEART RATE IRREGULAR VERTIGO 1
C HEART RATE IRREGULAR VIRAL INFECTION 1
C HEART RATE IRREGULAR WEIGHT DECREASED 1
C HYPERSENSITIVITY MALAISE 2
C HYPERSENSITIVITY VOMITING 2
C HYPERTENSION NAUSEA 1
C HYPERTENSION VOMITING 1
C ROSACEA NAUSEA 1
C ROSACEA VOMITING 1
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