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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