Ingenol mebutate


DB05013



General information:


Withdrawn ID: DB05013
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): D06BX02
Molecular Formula: C25H34O6
Molweight: 430.541



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First withdrawn: 2020
Reference: https://www.ema.europa.eu/en/medicines/human/referrals/picato



Side-effects:

Total reported cases (submitted by medical professionals) with Ingenol mebutate as primary suspect: 695


Reported final outcomes:
Hospitalization (initial or prolonged): 33
Disability: 19
Life-Threatening condition: 13
Death: 3


Reported side-effects:

Side-effect Case number
APPLICATION SITE ERYTHEMA172
APPLICATION SITE VESICLES154
APPLICATION SITE PAIN130
Incorrect drug administration duration124
Drug administered at inappropriate site75
APPLICATION SITE SCAB58
APPLICATION SITE SWELLING52
Drug ineffective48
Inappropriate schedule of drug administration47
Application site exfoliation46
Incorrect dose administered44
Squamous cell carcinoma42
Squamous cell carcinoma of skin41
Drug administration error39
Application site reaction37
Eye swelling36
Accidental exposure to product30
Application site burn29
Application site pustules27
Application site discharge27
Headache26
Eye irritation20
Erythema20
Application site inflammation20
Hypersensitivity19
Incorrect product administration duration18
Application site erosion18
Application site scar17
Application site discolouration17
Periorbital oedema16
Application site ulcer16
APPLICATION SITE PRURITUS16
Product use issue15
Eye pain15
Skin reaction14
Eyelid oedema14
Application site oedema14
Pain13
Nausea13
Medication error13
Swelling face12
Application site paraesthesia12
Application site irritation12
Inappropriate schedule of product administration11
Herpes zoster11
Product storage error10
Dyspnoea10
Drug dispensing error10
DERMATITIS CONTACT10
Blister10
Pyrexia9
Ocular hyperaemia9
Basal cell carcinoma9
Application site warmth9
Application site infection9
Application site dryness9
Off label use8
No adverse event8
Lip swelling8
Insomnia8
Swollen tongue7
Product packaging quantity issue7
Influenza like illness7
Incorrect product storage7
Dizziness7
Burns second degree7
Adverse event7
Treatment noncompliance6
Social problem6
Skin exfoliation6
Pruritus6
Paraesthesia oral6
Neoplasm malignant6
Inflammation6
Diarrhoea6
Application site rash6
Application site haemorrhage6
Angioedema6
Visual impairment5
Vision blurred5
SKIN ULCER5
Product use in unapproved indication5
Paraesthesia5
Lacrimation increased5
Keratoacanthoma5
Face oedema5
Disease progression5
Dermatitis5
APPLICATION SITE HYPERSENSITIVITY5
Vomiting4
Skin lesion4
Product quality issue4
Oropharyngeal pain4
Mouth ulceration4
Malignant melanoma4
Malaise4
Fatigue4
Dysphagia4
Dermatitis bullous4
Application site discomfort4
Actinic keratosis4
Wrong technique in product usage process3
Wrong technique in drug usage process3
Urticaria3
Throat irritation3
Therapeutic response unexpected3
Swelling3
Skin erosion3
Sepsis3
Scab3
Rhinorrhoea3
Quality of life decreased3
Post inflammatory pigmentation change3
Periorbital swelling3
MYALGIA3
Multiple use of single-use product3
Lip oedema3
Hypoaesthesia oral3
Eye burns3
Dysgeusia3
Dry mouth3
Disease recurrence3
Corneal abrasion3
Chills3
Bowen's disease3
Atypical fibroxanthoma3
Asthenia3
Application site papules3
Application site induration3
Accidental overdose3
Visual acuity reduced2
Trigeminal nerve disorder2
Transient ischaemic attack2
Toxicity to various agents2
Toxic skin eruption2
Throat tightness2
Superinfection2
STAPHYLOCOCCAL INFECTION2
Skin warm2
Sinus pain2
Seborrhoeic keratosis2
Scar2
Rash pustular2
Rash generalised2
Rash erythematous2
Rash2
Pulmonary embolism2
Product administration error2
Product administered at inappropriate site2
Pharyngeal oedema2
Papule2
Overdose2
Oedema2
Madarosis2
Loss of consciousness2
Local swelling2
Lentigo maligna2
Impetigo2
Hypoaesthesia2
Hypertension2
Hyperkeratosis2
Hyperhidrosis2
Gait disturbance2
Eyelid ptosis2
Eye oedema2
Exfoliative rash2
Erysipelas2
Diplopia2
Dermatitis allergic2
Condition aggravated2
Cellulitis2
Burns first degree2
Blood pressure increased2
Blindness transient2
Blindness2
Arthralgia2
Application site telangiectasia2
Anxiety2
Anosmia2
Anaphylactic reaction2
Alopecia2
Vitreous floaters1
Vitreous detachment1
VIIth nerve paralysis1
Urinary retention1
Unevaluable event1
Underdose1
Ulcerative keratitis1
Ulcer1
Tremor1
Tooth disorder1
Tongue pruritus1
Tongue oedema1
Tongue discomfort1
Tongue discolouration1
Thermal burn1
Superinfection bacterial1
Sudden death1
Stevens-Johnson syndrome1
Spontaneous haematoma1
Somnolence1
Skin tightness1
Skin swelling1
Skin squamous cell carcinoma recurrent1
Skin neoplasm excision1
Skin necrosis1
Skin mass1
Skin infection1
Skin hypopigmentation1
Skin hypertrophy1
Skin fragility1
Skin cancer metastatic1
Skin cancer1
Skin burning sensation1
Sinusitis1
Sinus disorder1
Sensory disturbance1
Sensation of foreign body1
Secretion discharge1
Scleritis1
Sarcoma of skin1
Rash morbilliform1
Rash maculo-papular1
Rash macular1
Purulence1
Pupils unequal1
Pupillary disorder1
Product container seal issue1
Product container issue1
Primary mediastinal large B-cell lymphoma1
Prescribed overdose1
Post herpetic neuralgia1
Porokeratosis1
Pneumonia aspiration1
Pigmentation disorder1
Photosensitivity reaction1
Photophobia1
Pharyngitis1
Pharyngeal swelling1
Pharyngeal erythema1
Periorbital inflammation1
Periorbital infection1
Penile necrosis1
Palpitations1
Pain of skin1
Pain in jaw1
Otorrhoea1
Osteoarthritis1
Orthopnoea1
Oral pain1
Oral fungal infection1
Ophthalmoplegia1
Ophthalmic herpes zoster1
Oedema peripheral1
Ocular discomfort1
Nonspecific reaction1
Non-Hodgkin's lymphoma1
No therapeutic response1
Nipple pain1
Neoplasm skin1
Neoplasm progression1
Myocardial infarction1
Muscular weakness1
Muscle contracture1
Mucosal inflammation1
Mouth haemorrhage1
Migraine1
Metastatic malignant melanoma1
Metastases to lung1
Melanocytic hyperplasia1
Melaena1
Macular fibrosis1
Lymphoedema1
Lymphadenopathy1
Loss of personal independence in daily activities1
Localised oedema1
Liver function test abnormal1
Lip pain1
Lip blister1
Lethargy1
Laryngeal oedema1
Lacrimation decreased1
Keratosis pilaris1
Keloid scar1
Joint range of motion decreased1
Joint instability1
Intestinal obstruction1
Initial insomnia1
Influenza1
Incorrect dosage administered1
Impaired work ability1
Impaired healing1
IIIrd nerve paralysis1
Hypokinesia1
Hyperaesthesia1
Hordeolum1
Herpes zoster cutaneous disseminated1
Herpes simplex1
Heart rate increased1
Haematemesis1
Granuloma skin1
Generalised erythema1
Gastroenteritis1
Fibrous histiocytoma1
Feeling hot1
Feeling abnormal1
Fat necrosis1
Fall1
Facial paralysis1
Facial pain1
Facial asymmetry1
Eyelid margin crusting1
Eyelid irritation1
Eye operation1
Eye injury1
Eye inflammation1
Eye infection1
Eye discharge1
Erythema of eyelid1
Eosinophilic cellulitis1
Entropion1
Eczema herpeticum1
Eczema1
Eating disorder1
Ear pain1
Dysuria1
Dysphonia1
Dry skin1
Drug prescribing error1
Drug intolerance1
Drug hypersensitivity1
Drug dose omission1
Dermatitis exfoliative1
Dermatitis atopic1
Dental necrosis1
Dental discomfort1
Deafness1
Cough1
Corneal infection1
Corneal graft rejection1
Corneal bleeding1
Conjunctivitis1
Conjunctival hyperaemia1
Concomitant disease progression1
Cold sweat1
Circumoral oedema1
Chest pain1
Chest discomfort1
Chemical eye injury1
Carcinoma in situ1
Cancer surgery1
Burns third degree1
Burning sensation1
Breath odour1
Breast cancer1
Bradycardia1
Bone pain1
Body temperature increased1
Blister rupture1
Blindness unilateral1
Basosquamous carcinoma1
Bacterial infection1
Atrial fibrillation1
Application site wound1
Application site urticaria1
Application site nodule1
Application site hypoaesthesia1
Application site fissure1
Application site extravasation1
Application site dermatitis1
Application site bruise1
Aphthous stomatitis1
Anaphylactoid reaction1
Anaphylactic shock1
Alopecia scarring1
Allergic keratitis1
Aggression1
Ageusia1
Administration site scar1
Administration site indentation1
Activities of daily living impaired1
Acne1
Abscess bacterial1
Abdominal pain1
Abdominal discomfort1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
Q05655 4.1 Protein kinase C delta type KPCD_HUMAN



Toxicity information:



External links:

ChEBML: CHEMBL1863513