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More information: STITCH, PubChem (stereo-specific compound: 1) and possibly Wikipedia

ATC Codes: None found

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Dermatitis acneiform Dermatitis acneiform very common, 0% - 90% x x
Diarrhoea Diarrhoea very common, 0% - 96% x x
Dermatitis Rash very common, 0% - 90% x x
Rash Rash very common, 0% - 90% x x
Paronychia Paronychia very common, 0% - 58% x x
Stomatitis Stomatitis very common, 0% - 71% x x
Mouth ulceration x
Decreased appetite Decreased appetite very common, 0% - 29% x x
Epistaxis Epistaxis very common, 0% - 17% x x
Pruritus Pruritus very common, 0% - 21% x x
Dry skin Dry skin very common, 0% - 31% x x
Dehydration Dehydration common x
Dysgeusia Dysgeusia common x
Dyspepsia Dyspepsia common x
Renal failure Renal failure common x
Renal impairment common x
Muscle spasms Muscle spasms common x
Aspartate aminotransferase increased Aspartate aminotransferase increased common, 2% - 8% x x
Dry eye Dry eye common x
Renal impairment Renal impairment common x
Hypokalaemia Hypokalaemia common, 2% - 11% x x
Vomiting Vomiting 0% - 23% x x
Alanine aminotransferase increased Alanine aminotransferase increased common, 0% - 11% x x
Cystitis Cystitis common, 0% - 13% x x
Bladder pain Cystitis common, 0% - 13% x x
Cystitis noninfective Cystitis common, 0% - 13% x x
Weight decreased Weight decreased common, 0% - 17% x x
Cheilitis Cheilitis common, 0% - 12% x x
Conjunctivitis Conjunctivitis common, 0% - 11% x x
Body temperature increased Body temperature increased common, 0% - 12% x x
Nasopharyngitis Rhinorrhoea common, 0% - 11% x x
Nasopharyngitis 0% - 14% x
Rhinorrhoea Rhinorrhoea common, 0% - 11% x x
Asthenia Fatigue 0% - 19% x x
Fatigue Fatigue 0% - 19% x x
Nausea Nausea 0% - 25% x
Keratitis Keratitis uncommon x x
Interstitial lung disease Interstitial lung disease uncommon x x
Pneumonia Pneumonia 0.43% x
Sepsis Sepsis 0.43% x
Alopecia Alopecia 0% - 13% x
Back pain Back pain 0% - 14% x
Mental disorder Mental disorder x
Infection Infection x x
Connective tissue disorder Connective tissue disorder x
Constipation Constipation 0% - 13% x
Cough Cough 0% - 15% x
Dizziness Dizziness 0% - 11% x
Dyspnoea Dyspnoea x
Eye disorder Eye disorder x x
Gastrointestinal disorder Gastrointestinal disorder x x
Headache Headache 0% - 14% x
Mediastinal disorder Mediastinal disorder x x
Nervous system disorder Nervous system disorder x
Skin disorder Skin disorder x
Unspecified disorder of skin and subcutaneous tissue x x
Aphthous stomatitis Aphthous stomatitis x
Upper respiratory tract infection Upper respiratory tract infection 0% - 11% x
Urinary tract infection Urinary tract infection x
Urethral disorder Urinary tract disorder x
Urinary tract disorder Urinary tract disorder x
Mouth ulceration Mouth ulceration x
Malnutrition Malnutrition x x
Mucosal ulceration Mucosal ulceration x
Mucosal inflammation Mucosal ulceration x
Mucosal inflammation x
Conjunctival irritation Conjunctival irritation x
Disease progression Disease progression x
Left ventricular dysfunction Left ventricular dysfunction x
Ventricular dysfunction Ventricular dysfunction x
Acne pustular Acne pustular x
Hepatobiliary disease Hepatobiliary disease x
Nail infection Nail infection x
Oral mucosa erosion Oral mucosa erosion x
Pruritus generalised Pruritus generalised x
Diastolic dysfunction Diastolic dysfunction x
Nail bed infection Nail bed infection x
Mucosal erosion Mucosal erosion x
Skin fissures Chapped skin x
Infestation Infestation NOS x x
Blood potassium decreased Blood potassium decreased x
Insomnia Insomnia 0% - 15% x
Pulmonary toxicity Pulmonary toxicity x
Conjunctival hyperaemia Conjunctival hyperaemia x
Nasal inflammation Nasal inflammation x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:38
Source:FDA Structured Product Label

afatinib (as afatinib dimaleate) / GIOTRIF

Side effects:67

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label