Isotretinoin - Adverse Effects

Adverse Effects

Increasingly higher dosages will result in higher toxicity, resembling vitamin A toxicity. Following are adverse drug reactions from Roches UK product information for Roaccutane as of October 2010.

Type of disorders	Very common (≥ 1/10)	Common (≥ 1/100, < 1/10)	Rare (≥ 1/10 000,< 1/1000)	Very rare (≤ 1/10 000)
Infections				Gram positive (mucocutaneous) bacterial infection
Blood and lymphatic system	Anemia Increased red blood cell sedimentation rate Thrombocytopenia Thrombocytosis	Neutropenia		Lymphadenopathy
Immune system			Allergic skin reaction Anaphylactic reactions Hypersensitivity
Metabolism				Diabetes mellitus Hyperuricaemia
Psychiatric			Depression Aggravated depression Aggressive tendencies Anxiety Mood alterations	Abnormal behaviour Psychotic disorder Suicidal ideation Suicide attempt Suicide
Nervous system		Headache		Benign intracranial hypertension Convulsions Drowsiness Dizziness
Eye	Blepharitis Conjunctivitis Dry eyes Eye irritation			Blurred vision Cataract Colour blindness Contact lens intolerance Corneal opacity Decreased night vision Keratitis Papilloedema Photophobia Visual disturbances
Ear				Impaired hearing
Vascular				Vasculitis (i.e. Wegener's granulomatosis, allergic vasculitis)
Respiratory, thoracic and mediastinal		Epistaxis Nasal dryness Nasopharyngitis		Bronchospasm (particularly in patients with asthma) Hoarseness
Gastrointestinal				Colitis Ileitis Dry throat Gastrointestinal haemorrhage Haemorrhagic diarrhoea Inflammatory bowel disease Nausea Pancreatitis
Hepatobiliary	Increased transaminase			Hepatitis
Skin and subcutaneous tissues	Cheilitis Dermatitis Dry skin Localised exfoliation Pruritus Rash Erythematous Skin fragility		Alopecia	Acne fulminans Aggravated acne (acne flare) Erythema (facial) Exanthema Hair disorders Hirsutism Nail dystrophy Paronychia Photosensitivity reaction Pyogenic granuloma Skin hyperpigmentation Increased sweating
Musculo-skeletal and connective tissue	Arthralgia Myalgia Back pain			Arthritis Calcinosis (calcification of ligaments and tendons) Premature epiphyseal fusion Exostosis Hyperostosis Osteopenia Tendonitis
Renal and urinary				Glomerulonephritis
General				Increased formation of granulation tissue Malaise
Investigation	Increased triglycerides Decreased HDL	Increased blood cholesterol Increased blood glucose Haematuria Proteinuria		Increased creatine phosphokinase

The most common side effects are mucocutaneous and ocular in nature (i.e., cheilitis, ocular sicca, and decreased dark adaptation). It can also cause xerosis. Patients should be made aware of these side effects before taking isotretinoin and also that use of moisturizers and eye drops can help to mitigate them. Sometimes, however, the dose needs to be decreased to reduce the induction of side effects.

In a study from 2011, twenty male patients all developed heart hypertrophy and hypovolemia after 10 weeks of isotretinoin treatment with 0.5 mg/kg/day.

During a prospective study in Mexico that evaluated the efficacy and safety of isotretinoin in acne, six male patients reported difficulties in maintaining adequate penile erection, in addition to depression, suggesting a potential link between isotretinoin and risk of erectile dysfunction.

Research suggests vitamin E supplementation in the form of alpha-tocopherol reduces the toxicity of isotretinoin treatment in subjects with cancer and myelodysplastic syndrome. In contrast, a randomized study in 82 subjects taking isotretinoin (1 mg/kg/day) for acne vulgaris found no difference in the incidence or severity of side effects in the group taking an additional 800 IU/day of vitamin E in the form of d-l-alphatocopherol.

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