Adverse reactions : תופעות לוואי

4.8. Undesirable Effects

Summary of safety profile
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 mucosa e.g. of the lips (cheilitis), the nasal mucosa (epistaxis), and the eyes (conjunctivitis).

Tabulated list of adverse reactions
The incidence of the adverse reactions calculated from pooled clinical trial data involving 824 patients and from post-marketing data are presented in the table below. The adverse reactions are listed below by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness.
Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin 
System Organ Very common            Common      Rare                Very Rare             Not known* Class
Infections                                                          Gram positive (mucocutaneous) bacterial infection
Blood and       Thrombocytopenia, Neutropenia                       Lymphadenopathy lymphatic       anaemia,
system          thrombocytosis,
disorders       red blood cell sedimentation rate increased
Immune                                          Anaphylactic system                                          reactions,
disorders                                       hypersensitivity,
allergic skin reaction
Metabolism                                                          Diabetes mellitus, and Nutrition                                                       hyperuricaemia disorders
Psychiatric                                     Aggressive          Psychotic disorder, Depression, disorders                                       tendencies,         abnormal behaviour depression anxiety, mood                             aggravated,
alterations.                              suicide, suicide attempt, suicidal ideation
Nervous                             Headache                        Benign intracranial system                                                              hypertension, disorders                                                           convulsions, drowsiness,
dizziness
Eye disorders Blepharitis,                                          Papilloedema (as conjunctivitis, dry                                   sign of benign eye, eye irritation                                   intracranial hypertension),
cataract, colour blindness (colour vision deficiencies),
contact lens intolerance, corneal opacity, decreased

System Organ Very common                Common             Rare       Very Rare               Not known* Class night vision,
keratitis,
photophobia, visual disturbances,
blurred vision.
Ear and                                                               Hearing impaired labyrinth disorders
Vascular                                                              Vasculitis (for disorders                                                             example Wegener's granulomatosis,
allergic vasculitis)
Respiratory,                            Nasopharyng                   Bronchospasm thoracic and                            itis, epistaxis,              (particularly in mediastinal                             nasal dryness                 patients with disorders                                                             asthma), hoarseness Gastrointestin                                                        Inflammatory al disorders                                                          bowel disease, colitis, ileitis,
pancreatitis,
gastrointestinal haemorrhage,
haemorrhagic diarrhoea, nausea dry throat (see section 4.4)
Hepatobiliary Transaminase                                            Hepatitis disorders     increased (see section 4.4)
Skin and      Pruritus, rash                               Alopecia   Acne fulminans,         Erythema subcutaneous erythematous,                                            acne aggravated         multiforme, tissues       dermatitis, cheilitis,                                  (acne flare),           Stevens- disorders     dry skin, localised                                     erythema (facial),      Johnson exfoliation, skin                                       exanthema, hair         Syndrome, toxic fragility (risk of                                      disorders,              epidermal frictional trauma)                                      hirsutism, nail         necrolysis dystrophy,
paronychia,
photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation,
sweating increased
Musculoskelet    Arthralgia,                                          Arthritis, calcinosis   Rhabdomyolysis al and           myalgia, back pain                                   (calcification of       Sacroiliitis connective       (particularly in                                     ligaments and tissue           children and                                         tendons), epiphyses disorders        adolescent patients)                                 premature fusion, exostosis,
(hyperostosis),
reduced bone density, tendonitis


System Organ Very common              Common        Rare           Very Rare            Not known* Class
Renal and                                                          Glomerulonephritis Urethritis urinary disorders
Reproductive                                                                            Sexual system and                                                                              dysfunction breast                                                                                  including disorders                                                                               erectile dysfunction and decreased libido,
gynaecomastia,
vulvovaginal dryness, orgasm abnormal,
genital hypoaesthesia
General                                                            Granulation tissue disorders and                                                      (increased administration                                                     formation of), site conditions                                                    malaise Investigations Blood triglycerides    Blood                        Blood creatine increased, high       cholesterol                  phosphokinase density lipoprotein   increased,                   increased decreased             blood glucose increased,
haematuria,
proteinuria

* Cannot be estimated from the available data

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il