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Aldara (Imiquimod) - Side Effect Reports to FDA

 
 



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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