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) |
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Infections |
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Blood and lymphatic system |
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Immune system |
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Metabolism |
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Psychiatric |
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Nervous system |
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Eye |
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Ear |
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Vascular |
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Respiratory, thoracic and mediastinal |
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Gastrointestinal |
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Hepatobiliary |
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Skin and subcutaneous tissues |
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Musculo-skeletal and connective tissue |
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Renal and urinary |
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General |
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Investigation |
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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.
Read more about this topic: Isotretinoin
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