This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aldara (Imiquimod) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (12)
Death (1)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Headache (3),
Myalgia (3),
Fatigue (3),
Malaise (3),
Dizziness (3),
Thrombosis (2),
Drug Ineffective (2),
Pain (2),
Oropharyngeal Pain (2),
Pyrexia (2),
Influenza (2),
White Blood Cell Count Increased (2)
Possible Aldara side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-06-19
Patient: 54 year old female
Reactions: Eyelid Oedema, Haemorrhage, Pain, Vision Blurred, Retinal Vein Occlusion
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 2 year old female
Reported by a physician from United States on 2012-04-25
Patient: 2 year old female
Reactions: Vomiting, Cellulitis, Pyrexia, Postictal State, Somnolence, Grand MAL Convulsion, Dermatitis, Dysuria, Application Site Erythema, White Blood Cell Count Increased, Candidiasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 44 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-25
Patient: 44 year old male
Reactions: Drug Level Increased, Chills, Oropharyngeal Pain, Pyrexia, Myalgia, Fatigue, Haematocrit Decreased, Malaise, Dizziness, White Blood Cell Count Increased, Back Pain, Neutrophil Percentage Increased, Complications of Transplanted Kidney, Nausea, Blood Fibrinogen Increased, Haemodialysis, Haemoglobin Decreased, Renal Tubular Necrosis, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldara
Other drugs received by patient: Sirolimus; Cyclosporine; Amlodipine; Azathioprine; Mycophenolate Mofetil; Prednisone TAB; Prograf; Atorvastatin Calcium; Flecainide Acetate; Aspirin; Ranitidine; Amiodarone HCL
Possible Aldara side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24
Patient: 47 year old male
Reactions: Pulmonary Embolism, Pleural Effusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09
Patient: 54 year old female, weighing 62.6 kg (137.7 pounds)
Reactions: Erythema, Pneumonitis
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-03-01
Patient: 50 year old female, weighing 74.8 kg (164.7 pounds)
Reactions: Confusional State, Nerve Injury, Skin Exfoliation, Pain, Quality of Life Decreased, Scab, Headache, Brain Injury, Myalgia, Malaise, Chest Pain, Burns Third Degree, Skin Cancer, Dizziness, Open Wound, Muscle Spasms, Dyspnoea, Skin Disorder, Hypoaesthesia, Rash, Amnesia, Tremor, Skin Irritation, Impaired Healing, Visual Impairment, Thyroid Disorder, Immune System Disorder, Scar, Infection, Influenza Like Illness, Influenza
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Aldara
Other drugs received by patient: Efudex
Possible Aldara side effects in 42 year old female
Reported by a consumer/non-health professional from United States on 2012-02-15
Patient: 42 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Back Pain, Swollen Tongue, Headache, Oropharyngeal Pain, Fatigue, Neck Pain, Pulmonary Congestion, Influenza
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 41 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-30
Patient: 41 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Thyroiditis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in female
Reported by a physician from United States on 2011-12-12
Patient: female
Reactions: Thrombosis, Drug Ineffective
Drug(s) suspected as cause:
Wellbutrin
Dosage: (df)
Indication: Depression
Wellbutrin
Dosage: (df)
Indication: Anxiety
Aldara
Dosage: (df)
Indication: Precancerous Cells Present
Paxil
Dosage: (df)
Indication: Anxiety
Paxil
Dosage: (df)
Indication: Depression
Cymbalta
Dosage: (df)
Indication: Anxiety
Cymbalta
Dosage: (df)
Indication: Depression
Other drugs received by patient: Ambien; Prozac; Nardil; Zoloft; Pamelor; Abilify; Remeron; Pristiq
Possible Aldara side effects in 62 year old female
Reported by a physician from United States on 2011-12-09
Patient: 62 year old female, weighing 72.7 kg (159.9 pounds)
Reactions: Thrombosis, Drug Ineffective, Oedema Peripheral
Drug(s) suspected as cause:
Paxil
Indication: Depression
Wellbutrin
Indication: Depression
Cymbalta
Indication: Depression
Aldara
Indication: Precancerous Cells Present
Other drugs received by patient: Nardil; Prozac; Pamelor; Abilify; Zoloft; Pristiq; Ambien; Remeron
Possible Aldara side effects in 43 year old male
Reported by a consumer/non-health professional from United States on 2011-11-07
Patient: 43 year old male, weighing 75.0 kg (165.0 pounds)
Reactions: Lymphadenopathy, Head Discomfort, Blood Glucagon Increased, Muscular Weakness, Mucosal Dryness, Swollen Tongue, Suicidal Ideation, Arrhythmia, Lymph Node Pain, DRY Mouth, Heart Rate Increased, Insomnia, Anger, Dizziness, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldara
Possible Aldara side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2011-10-03
Patient: 29 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: Incorrect Dose Administered, Hypotension, Breast Mass, Headache, Myalgia, Fatigue, Breast Swelling, Malaise, Loss of Employment, Activities of Daily Living Impaired, Dysuria
Drug(s) suspected as cause:
Aldara
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