Most of the adverse reactions of isotretinoin are dose-related. With the recommended dosage, the risk/benefit ratio is generally acceptable considering the severity of the disease.
Incidence more frequent:
chelitis (scaling, redness, burning, pain and other signs of inflammation of lips), epistaxis (nosebleeds) and skin infection.
Symptoms Associated with Hypervitaminosis A: The following symptoms are the most frequently reported: Dryness of the skin, dryness of the mucosae, eg of the lips, the nasal mucosa (epistaxis), the eyes (conjunctivitis, reversible corneal opacities and intolerance to contact lenses).
Skin and Appendages Disorders:
Exanthema, pruritus, dermatitis facialis, sweating, pyogenic granuloma, paronychia, nail dystrophy, increased formation of granulation tissue, persistent hair thinning, reversible alopecia, acne fulminans, hirsutism, hyperpigmentation, photosensitivity.
Musculoskeletal System Disorder:
Muscle pain, joint pain, hyperostosis and other bone changes, tendinitis.
Psychiatric and Central Nervous System Disorders:
Behavioral disorders, depression, headache, increased intracranial pressure, seizures.
Isolated cases of visual disturbances, impaired hearing at certain frequencies, photophobia, dark adaptation disturbances (decreased night vision), lenticular cataract, keratitis.
Gastrointestinal System Disorders:
Nausea, inflammatory bowel disease, eg colitis, ileitis and hemorrhage have been reported to occur.
Liver and Biliary System Disorders:
Transitory and reversible increases in transaminases, some cases of hepatitis. In many such cases, the changes have been within the normal range and values have returned to baseline levels during treatment. In other cases, however, it has been necessary to reduce the dose or discontinue treatment with isotretinoin.
Respiratory System Disorders:
Disorders of the Blood:
Decrease in white cell count, red blood cell parameters, increase or decrease in platelet count, elevated sedimentation rate.
Increase in serum triglyceride and cholesterol levels, hyperuricemia. Decreases in HDL have also been observed, particularly at high dosages and in predisposed patients (with a family history of lipid-metabolism disorders, diabetes, obesity or alcoholism). These changes too, are dose-related, and values return to normal on reduction of the dosage or withdrawal of the drug. Every patient should be warned about the possible occurrence of adverse effects.
Resistance Mechanism Disorders:
Local or systemic infections due to gram-positive microorganisms (Staphylococcus aureus
Lymphadenopathy, hematuria, and proteinuria, pancreatitis (especially patients with high serum triglyceride levels (>800 mg) treated with isotretinoin are at risk of developing pancreatitis), vasculitis (eg. Wegener's granulomatosis).
Bleeding or inflammation of gums; cataracts or corneal opacities.
Sexual dysfunction including erectile dysfunction and decreased libido.