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Picato (Ingenol Mebutate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Picato (Ingenol Mebutate) 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 (13)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Application Site Vesicles (5)Erythema (3)Myalgia (3)Skin Ulcer (3)Application Site Erythema (3)Staphylococcal Infection (3)Application Site Swelling (2)Pain (2)Pyrexia (2)Dermatitis Contact (2)Application Site Burn (2)Blister (2)

Possible Picato side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 73 year old female, weighing 50.8 kg (111.8 pounds)

Reactions: Application Site Swelling, Application Site Pain, Application Site Scab, Application Site Pruritus

Drug(s) suspected as cause:
Picato
    Dosage: 0.05 % 1 day chest ; 0.05 % 2nd day chest
    Indication: Actinic Keratosis
    Start date: 2012-07-08

Picato
    Dosage: 0.05 % 1 day chest ; 0.05 % 2nd day chest
    Indication: Actinic Keratosis
    Start date: 2012-07-09



Possible Picato side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: 64 year old female, weighing 61.7 kg (135.7 pounds)

Reactions: Swelling Face, Visual Impairment, Ocular Hyperaemia, Eye Swelling

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Picato
    Dosage: 1 dose once a day
    Indication: Skin Cancer
    Start date: 2012-06-08

Picato
    Dosage: 1 dose once a day
    Indication: Skin Cancer
    Start date: 2012-06-07



Possible Picato side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 61 year old female

Reactions: Application Site Discolouration, Application Site Infection, Conjunctivitis, Application Site Burn, Toxicity To Various Agents, Skin Depigmentation, Application Site Vesicles, Keratitis

Drug(s) suspected as cause:
Picato

Other drugs received by patient: Verapamil; Januvia; Vitamin (Vitamins Nos); Aspirin; Exemestane; Venlafaxine HCL; Calcium Carbonate; Zometa; Micardis; Metfformin Hydrochloride; Acidophilus (Lactobacillus Acidophilus)



Possible Picato side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-10

Patient: female

Reactions: Insomnia, Application Site Swelling, Eye Swelling, Application Site Burn, Pyrexia, Application Site Vesicles

Drug(s) suspected as cause:
Picato



Possible Picato side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-05

Patient: female

Reactions: Nerve Injury, Dysgeusia, Gout, Musculoskeletal Disorder, Discomfort

Drug(s) suspected as cause:
Picato

Other drugs received by patient: Lipitor; Lisinopril; Avista



Possible Picato side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 64 year old female

Reactions: Madarosis, Skin Ulcer, Pain, Scab

Drug(s) suspected as cause:
Picato
    Indication: Skin Chapped
    Start date: 2012-06-07
    End date: 2012-06-08

Picato
    Indication: Actinic Keratosis
    Start date: 2012-06-07
    End date: 2012-06-08

Picato
    Indication: Eyelid Exfoliation
    Start date: 2012-06-07
    End date: 2012-06-08

Other drugs received by patient: Synthroid; Crestor



Possible Picato side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: male

Reactions: Dermatitis Contact, Myalgia, Staphylococcal Infection, Skin Ulcer, Application Site Erythema, Application Site Vesicles, Application Site Hypersensitivity

Drug(s) suspected as cause:
Picato



Possible Picato side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: male

Reactions: Periorbital Oedema, Eyelid Oedema, Application Site Pustules, Headache, Erythema, Eye Pain, Influenza Like Illness

Drug(s) suspected as cause:
Picato

Other drugs received by patient: Toprol 50 (Metoprolol Succinate)



Possible Picato side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: male

Reactions: Dermatitis Contact, Myalgia, Staphylococcal Infection, Skin Ulcer, Application Site Erythema, Application Site Vesicles, Application Site Hypersensitivity

Drug(s) suspected as cause:
Picato



Possible Picato side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: male

Reactions: Application Site Reaction, Myalgia, Hypersensitivity, Staphylococcal Infection, Application Site Erythema, Application Site Vesicles

Drug(s) suspected as cause:
Picato



Possible Picato side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 42 year old female

Reactions: Skin Exfoliation, Pain, Pyrexia, Rash, Erythema, Blister

Drug(s) suspected as cause:
Picato



Possible Picato side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 42 year old female

Reactions: Chest Pain, Skin Disorder, Erythema, Blister

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Picato



Possible Picato side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 73 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Urticaria, Drug Prescribing Error, Discomfort

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Picato

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