Drug information for ALDARA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CREAM; TOPICAL 5% Prescription AB (Reference Drug) IMIQUIMOD imiquimod MEDICIS 20723
2012-04-13 Review
2010-10-19 Letter
2010-10-19 Label
2007-11-19 Review
2007-03-31 Letter
2007-03-31 Label
2005-08-11 Letter
2005-08-11 Label
2004-07-21 Label
2004-07-21 Letter
2004-05-26 Letter
2004-05-26 Label
2004-05-26 Letter
2004-05-26 Label
2004-05-26 Letter
2004-05-26 Label
2004-04-05 Label
2004-03-03 Letter
2003-04-22 Label

Drug Adverse Effects information for ALDARA

Role code Indications Reaction # Reports
PS ANOGENITAL WARTS ACTIVITIES OF DAILY LIVING IMPAIRED 1
PS ANOGENITAL WARTS BREAST MASS 1
PS ANOGENITAL WARTS BREAST SWELLING 1
PS ANOGENITAL WARTS DYSURIA 1
PS ANOGENITAL WARTS FATIGUE 1
PS ANOGENITAL WARTS HEADACHE 1
PS ANOGENITAL WARTS HYPOTENSION 1
PS ANOGENITAL WARTS INCORRECT DOSE ADMINISTERED 1
PS ANOGENITAL WARTS LOSS OF EMPLOYMENT 1
PS ANOGENITAL WARTS MALAISE 1
PS ANOGENITAL WARTS MYALGIA 1
PS SKIN PAPILLOMA ANGER 1
PS SKIN PAPILLOMA ARRHYTHMIA 1
PS SKIN PAPILLOMA BLOOD GLUCAGON INCREASED 1
PS SKIN PAPILLOMA DIZZINESS 1
PS SKIN PAPILLOMA DRY MOUTH 1
PS SKIN PAPILLOMA FEELING ABNORMAL 1
PS SKIN PAPILLOMA HEAD DISCOMFORT 1
PS SKIN PAPILLOMA HEART RATE INCREASED 1
PS SKIN PAPILLOMA INSOMNIA 1
PS SKIN PAPILLOMA LYMPH NODE PAIN 1
PS SKIN PAPILLOMA LYMPHADENOPATHY 1
PS SKIN PAPILLOMA MUCOSAL DRYNESS 1
PS SKIN PAPILLOMA MUSCULAR WEAKNESS 1
PS SKIN PAPILLOMA SUICIDAL IDEATION 1
PS SKIN PAPILLOMA SWOLLEN TONGUE 1
SS ANXIETY DRUG INEFFECTIVE 3
SS ANXIETY THROMBOSIS 3
SS DEPRESSION DRUG INEFFECTIVE 13
SS DEPRESSION OEDEMA PERIPHERAL 10
SS DEPRESSION THROMBOSIS 13
SS PRECANCEROUS CELLS PRESENT DRUG INEFFECTIVE 2
SS PRECANCEROUS CELLS PRESENT OEDEMA PERIPHERAL 1
SS PRECANCEROUS CELLS PRESENT THROMBOSIS 2
SS SLEEP DISORDER DRUG INEFFECTIVE 1
SS SLEEP DISORDER OEDEMA PERIPHERAL 1
SS SLEEP DISORDER THROMBOSIS 1
C BENIGN PROSTATIC HYPERPLASIA HAIR GROWTH ABNORMAL 1
C CONSTIPATION ASTHENIA 1
C CONSTIPATION ATELECTASIS 1
C CONSTIPATION DISTURBANCE IN ATTENTION 1
C CONSTIPATION EMOTIONAL DISORDER 1
C CONSTIPATION HEADACHE 1
C CONSTIPATION INJURY 1
C CONSTIPATION PAIN 1
C CONSTIPATION PULMONARY EMBOLISM 1
C CONTRACEPTION CHEST PAIN 1
C CONTRACEPTION DYSPNOEA 1
C CONTRACEPTION PULMONARY EMBOLISM 1
C GASTROOESOPHAGEAL REFLUX DISEASE CHEST PAIN 2
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA 2
C GASTROOESOPHAGEAL REFLUX DISEASE PULMONARY EMBOLISM 2
C JUVENILE ARTHRITIS ACTIVITIES OF DAILY LIVING IMPAIRED 1
C JUVENILE ARTHRITIS ARTHRALGIA 1
C JUVENILE ARTHRITIS BASAL CELL CARCINOMA 1
C JUVENILE ARTHRITIS BLOOD SODIUM DECREASED 1
C JUVENILE ARTHRITIS EAR INFECTION 1
C JUVENILE ARTHRITIS FINGER DEFORMITY 1
C JUVENILE ARTHRITIS JOINT SWELLING 1
C JUVENILE ARTHRITIS PNEUMONIA 1
C JUVENILE ARTHRITIS PYODERMA GANGRENOSUM 1
C JUVENILE ARTHRITIS RASH 1
C JUVENILE ARTHRITIS THERAPEUTIC RESPONSE DECREASED 1
C JUVENILE ARTHRITIS THIRST 1
C JUVENILE ARTHRITIS WEIGHT DECREASED 1
C MENOPAUSAL SYMPTOMS ACTIVITIES OF DAILY LIVING IMPAIRED 1
C MENOPAUSAL SYMPTOMS ARTHRALGIA 1
C MENOPAUSAL SYMPTOMS BASAL CELL CARCINOMA 1
C MENOPAUSAL SYMPTOMS BLOOD SODIUM DECREASED 1
C MENOPAUSAL SYMPTOMS EAR INFECTION 1
C MENOPAUSAL SYMPTOMS FINGER DEFORMITY 1
C MENOPAUSAL SYMPTOMS JOINT SWELLING 1
C MENOPAUSAL SYMPTOMS PNEUMONIA 1
C MENOPAUSAL SYMPTOMS PYODERMA GANGRENOSUM 1
C MENOPAUSAL SYMPTOMS RASH 1
C MENOPAUSAL SYMPTOMS THERAPEUTIC RESPONSE DECREASED 1
C MENOPAUSAL SYMPTOMS THIRST 1
C MENOPAUSAL SYMPTOMS WEIGHT DECREASED 1
C PAIN ASTHENIA 1
C PAIN ATELECTASIS 1
C PAIN DISTURBANCE IN ATTENTION 1
C PAIN EMOTIONAL DISORDER 1
C PAIN HEADACHE 1
C PAIN INJURY 1
C PAIN PAIN 1
C PAIN PULMONARY EMBOLISM 1
C PLEURISY CHEST PAIN 5
C PLEURISY DYSPNOEA 5
C PLEURISY PULMONARY EMBOLISM 5
C POLYARTHRITIS ACTIVITIES OF DAILY LIVING IMPAIRED 1
C POLYARTHRITIS ARTHRALGIA 1
C POLYARTHRITIS BASAL CELL CARCINOMA 1
C POLYARTHRITIS BLOOD SODIUM DECREASED 1
C POLYARTHRITIS EAR INFECTION 1
C POLYARTHRITIS FINGER DEFORMITY 1
C POLYARTHRITIS JOINT SWELLING 1
C POLYARTHRITIS PNEUMONIA 1
C POLYARTHRITIS PYODERMA GANGRENOSUM 1
C POLYARTHRITIS RASH 1
C POLYARTHRITIS THERAPEUTIC RESPONSE DECREASED 1
C POLYARTHRITIS THIRST 1
C POLYARTHRITIS WEIGHT DECREASED 1
C RHEUMATOID ARTHRITIS ACTIVITIES OF DAILY LIVING IMPAIRED 1
C RHEUMATOID ARTHRITIS ARTHRALGIA 1
C RHEUMATOID ARTHRITIS BASAL CELL CARCINOMA 1
C RHEUMATOID ARTHRITIS BLOOD SODIUM DECREASED 1
C RHEUMATOID ARTHRITIS EAR INFECTION 1
C RHEUMATOID ARTHRITIS FINGER DEFORMITY 1
C RHEUMATOID ARTHRITIS JOINT SWELLING 1
C RHEUMATOID ARTHRITIS PNEUMONIA 1
C RHEUMATOID ARTHRITIS PYODERMA GANGRENOSUM 1
C RHEUMATOID ARTHRITIS RASH 1
C RHEUMATOID ARTHRITIS THERAPEUTIC RESPONSE DECREASED 1
C RHEUMATOID ARTHRITIS THIRST 1
C RHEUMATOID ARTHRITIS WEIGHT DECREASED 1
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