ALDARA INJURY REPORTS FROM FDA RECORDS

 


The following are examples of how our reports to the FDA get posted into their records.  There are no names of course on these reports, at least not released to the public. 

 

Adverse event in 74 year old male receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United States on 2007-01-05

Patient: 74 year old male, weighing 72.6 kg (159.7 pounds)

Adverse reactions / side effects: Squameous Cell Carcinoma, Lymphoma

Adverse event resulted in: life threatening event, hospitalization, disability

Suspect drug(s):
Aldara (Imiquimod)

 


 

Adverse event in 70 year old male receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-10-25

Patient: 70 year old male

Adverse reactions / side effects: Thrombosis, Inappropriate Schedule of Drug Administration, Application Site Discolouration, Adverse Drug Reaction, Hypercoagulation, Overdose, Skin Discolouration, Venous Thrombosis, Skin Necrosis, Application Site Erythema, Vasculitis, Application Site Scab, Application Site Irritation

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 49 year old male receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-10-23

Patient: 49 year old male, weighing 95.3 kg (209.6 pounds)

Adverse reactions / side effects: Mucosal Inflammation, Inner Ear Inflammation, Tinnitus, Insomnia, Muscular Weakness, Parkinson's Disease, Otosalpingitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 49 year old female receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-07-31

Patient: 49 year old female, weighing 61.7 kg (135.7 pounds)

Adverse reactions / side effects: Basedow's Disease, Pharyngeal Oedema, Application Site Bleeding, Goitre, Scab, Influenza Like Illness

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 46 year old female receiving Aldara (Imiquimod)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-30

Patient: 46 year old female, weighing 58.1 kg (127.7 pounds)

Adverse reactions / side effects: Burning Sensation, Swelling, Genital Pain, Pain, Application Site Pain, Erythema

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 61 year old male receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-07-23

Patient: 61 year old male, weighing 93.0 kg (204.6 pounds)

Adverse reactions / side effects: Medication Error, Skin Haemorrhage, Skin Disorder, Drug Prescribing Error

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 48 year old male receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-05-31

Patient: 48 year old male, weighing 90.7 kg (199.6 pounds)

Adverse reactions / side effects: White Blood Cell Count Decreased, Blood Alkaline Phosphatase Increased, Hepatic Enzyme Abnormal, Blood Glucagon Increased, Alanine Aminotransferase Increased, Chills, Rash, Headache, Pyrexia, Paraesthesia, Myalgia, RED Blood Cell Count Decreased, Proteinuria, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara (Imiquimod)

Other drugs received by patient: Ezetimibe and Simvastatin (Vytorin)


 

Adverse event in 56 year old male receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-05-31

Patient: 56 year old male, weighing 64.0 kg (140.7 pounds)

Adverse reactions / side effects: Head Discomfort, Hypotension

Suspect drug(s):
Aldara (Imiquimod)

Other drugs received by patient: Tricor; Crestor; Aspirin


 

Adverse event in female receiving Aldara (Imiquimod)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-08

Patient: female, weighing 58.5 kg (128.7 pounds)

Adverse reactions / side effects: Mucosal Inflammation, Oral Intake Reduced, Arthralgia, Anorexia, Pyrexia, Nasal Congestion, Cough

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 40 year old female receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United States on 2007-05-07

Patient: 40 year old female, weighing 50.8 kg (111.8 pounds)

Adverse reactions / side effects: Back Pain, Nausea, Pain in Extremity, Heart Rate Increased, Pain, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara
    Dosage: thin layer every other night top
    Administration route: Topical
    Indication: Prophylaxis
    Start date: 2007-03-29
    End date: 2007-04-10

Aldara
    Dosage: thin layer every other night top
    Administration route: Topical
    Indication: Wart Excision
    Start date: 2007-03-29
    End date: 2007-04-10


 

Adverse event in 37 year old female receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-04-26

Patient: 37 year old female

Adverse reactions / side effects: Agitation, Depression, Suicidal Ideation, Aggression

Suspect drug(s):
Aldara (Imiquimod)

Other drugs received by patient: Topamax; Lamictal; Cymbalta; Ambien; Clonazepam


 

Adverse event in male receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-03-29

Patient: male, weighing 93.0 kg (204.6 pounds)

Adverse reactions / side effects: White Blood Cell Count Decreased, Fatigue, Viral Infection, Headache

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in female receiving Aldara (Imiquimod)

Reported by a consumer/non-health professional from United States on 2007-03-22

Patient: female, weighing 62.6 kg (137.7 pounds)

Adverse reactions / side effects: Lung Disorder, Drug Exposure During Pregnancy, Foetal Growth Retardation, Pregnancy

Suspect drug(s):
Aldara
    Dosage: application - 5xw - topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-06-01
    End date: 2006-08-01

Aldara
    Dosage: application - 5xw - topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-08-01
    End date: 2006-10-01

Aldara
    Dosage: application - 5xw - topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-10-01
    End date: 2006-12-01

Fexofenadine with Pseudoephedrine (Allegra-D)
    Dosage: 1 - daily - po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication


 

Adverse event in 76 year old male receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-03-12

Patient: 76 year old male

Adverse reactions / side effects: Neuroendocrine Carcinoma of THE Skin

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 75 year old male receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from France on 2007-02-23

Patient: 75 year old male

Adverse reactions / side effects: Myalgia, Fatigue, C-Reactive Protein Increased, Application Site Erythema, RED Blood Cell Sedimentation Rate Increased, Application Site Pruritus, Influenza Like Illness

Suspect drug(s):
Aldara (Imiquimod)

Other drugs received by patient: Xatral LP (Alufuzosin Hydrochloride); Prednisone; Methotrexate


 

Adverse event in female receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United Kingdom on 2007-02-15

Patient: female

Adverse reactions / side effects: Lymphoma

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 26 year old female receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United Kingdom on 2007-02-15

Patient: 26 year old female

Adverse reactions / side effects: Anal Discomfort, Application Site Inflammation, Pruritus ANI, Application Site Ulcer, Proctalgia

Adverse event resulted in: disablity

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 58 year old female receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-02-15

Patient: 58 year old female

Adverse reactions / side effects: Localised Infection, Drug Dose Omission, Application Site Reaction, Erythema Multiforme, Application Site Scab

Suspect drug(s):
Aldara
    Dosage: (0.5 sachet, 5 in 1 week(s), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: (0.5 sachet, 5 in 1 week(s), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: (0.5 sachet, 5 in 1 week(s), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-12-25
    End date: 2007-01-13

Aldara
    Dosage: (0.5 sachet, 5 in 1 week(s), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-12-25
    End date: 2007-01-13

Altace

Hydrochlorothiazide

Zetia

Folic Acid

Aspirin

Fish OIL

Keflex


 

Adverse event in 27 year old female receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United States on 2007-02-07

Patient: 27 year old female, weighing 59.0 kg (129.7 pounds)

Adverse reactions / side effects: Nasopharyngitis, Vulvovaginal Discomfort, Application Site Pain, Swelling, Dysuria, Application Site Ulcer, Sinusitis, Influenza Like Illness

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 58 year old female receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-01-30

Patient: 58 year old female

Adverse reactions / side effects: Staphylococcal Skin Infection, Toxic Epidermal Necrolysis, Oral Mucosal Exfoliation, Eosinophilia, Fatigue, Malaise, Erythema Multiforme, Application Site Scab

Suspect drug(s):
Aldara
    Dosage: (0.5 sachet, 5 in 1 week (s)), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: (0.5 sachet, 5 in 1 week (s)), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: (0.5 sachet, 5 in 1 week (s)), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-12-25
    End date: 2007-01-13

Aldara
    Dosage: (0.5 sachet, 5 in 1 week (s)), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-12-25
    End date: 2007-01-13

Altace

Hydrochlorothiazide

Zetia

Folic Acid

Aspirin

Fish OIL

Keflex


 

Adverse event in 17 year old male receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-01-30

Patient: 17 year old male

Adverse reactions / side effects: Nausea, Oedema Peripheral, Drug Hypersensitivity, Influenza Like Illness

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 57 year old male receiving Aldara (Imiquimod)

Reported by a individual with unspecified qualification from United States on 2007-01-29

Patient: 57 year old male, weighing 68.0 kg (149.7 pounds)

Adverse reactions / side effects: Pleurisy, Influenza

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara (Imiquimod)


 

Adverse event in 58 year old female receiving Aldara (Imiquimod)

Reported by a physician from United States on 2007-01-29

Patient: 58 year old female

Adverse reactions / side effects: Oral Intake Reduced, Drug Dose Omission, Application Site Reaction, Staphylococcal Infection, Drug Hypersensitivity, Toxic Epidermal Necrolysis, Erythema Multiforme, Herpes Zoster

Suspect drug(s):
Aldara
    Dosage: 0.5 scahet, 5 in 1 weeks (s)), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: 0.5 scahet, 5 in 1 weeks (s)), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-01-01
    End date: 2006-01-01

Aldara
    Dosage: 0.5 scahet, 5 in 1 weeks (s)), topical
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2006-12-25
    End date: 2007-01-13

Aldara
    Dosage: 0.5 scahet, 5 in 1 weeks (s)), topical
    Administration route: Topical
    Indication: Basal Cell Carcinoma
    Start date: 2006-12-25
    End date: 2007-01-13

Altace

Hydrochlorothiazide

Zetia

Folic Acid

Aspirin

Fish OIL

Keflex


 

 

 

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