<p>Some of the side effects associated with the use of Isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped. The following symptoms are the most commonly reported undesirable effects with Isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).<br />
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The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data. Frequency categories are defined as Very common (&sup3;1/10), Common (&sup3;1/100 to &lt;1/10), Uncommon (&sup3;1/1,000 to &lt;1/100), Rare (&sup3;1/10,000 to &lt;1/1,000), Very rare (&sup3;1/10,000 to &lt;1/1,000) and not known (cannot be estimated from the available data. Infections: Very Rare: Gram positive (mucocutaneous) bacterial infection Blood and lymphatic system disorders: Very common: Anaemia, red blood cell sedimentation rate increased, thrombocytopenia, thrombocytosis; Common: Neutropenia; Very Rare: Lymphadenopathy Immune system disorders: Rare: Allergic skin reaction, anaphylactic reactions, hypersensitivity Metabolism and nutrition disorders: Very Rare: Diabetes mellitus, hyperuricaemia Psychiatric disorders: Rare: Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations. Very Rare: Abnormal behaviour, psychotic disorder, suicidal ideation suicide attempt, suicide Nervous system disorders: Common: Headache; Very Rare: Benign intracranial hypertension, convulsions, drowsiness, dizziness Eye disorders: Very Common: Blepharitis, conjunctivitis, dry eye, eye irritation; Very Rare: Blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as sign of benign intracranial hypertension), photophobia, visual disturbances. Ear and labyrinth disorders: Very Rare: Hearing impaired Vascular disorders: Very Rare: Vasculitis (for example Wegener&#39;s granulomatosis, allergic vasculitis) Respiratory, thoracic and mediastinal disorders: Common: Epistaxis, nasal dryness, nasopharyngitis, Very Rare: Bronchospasm (particularly in patients with asthma), hoarseness Gastrointestinal disorders: Very Rare: Colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis Hepatobiliary disorders: Very Common: Transaminase increased; Very rare: Hepatitis Skin and subcutaneous tissues disorders: Very Common: Pruritus, rash erythematous, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility (risk of frictional trauma), Rare: Alopecia, Very Rare: Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased. Musculo-skeletal and connective tissue disorders: Very Common: Arthralgia, myalgia, back pain (particularly in children and adolescent patients), Very Rare: Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis. Renal and urinary disorders: Very Rare: Glomerulonephritis. General disorders and administration site conditions: Very Rare: Granulation tissue (increased formation of), malaise. Overdose Isotretinoin is a derivative of vitamin A. Although the acute toxicity of Isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Isotretinoin would probably be similar. These symptoms would be expected to be reversible and to subside without the need for treatment. Pharmaceutical precautions Store in a cool and dry place protected from light.</p>