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
Ads by Google