Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following undesirable effects have been reported with selegiline during clinical trials and/or post-marketing use.
They are listed below as MedDRA preferred term by system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 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), Not known (cannot be established from the available data).


System Organ Class                         Frequency                             Undesirable effects 

Infections and infestations                Uncommon                              Pharyngitis Blood and lymphatic system                 Uncommon                              Leucocytopenia, thrombocytopenia disorders
Metabolism and nutrition                   Uncommon                              Loss of appetite disorders
Common                                Sleeping disorders, confusion,
hallucinations, depression
Uncommon                              Abnormal dreams, agitation,
Psychiatric disorders anxiety, psychoses, mood change
Not known                             Hypersexuality*
Common                                Abnormal movements (such as dyskinesias, akinesia,
Nervous system disorders bradykinesia), dizziness, headache,
impaired balance, tremor
Uncommon                              mild transient sleep disorder
Eye disorders                              Uncommon                              Blurred vision Ear and labyrinth disorders                Common                                Vertigo Common                                Bradycardia
Cardiac disorders                          Uncommon                              Arrhythmias, palpitations, angina pectoris, supraventricular tachycardia
Common                                hypotension, hypertension
Vascular disorders                         Uncommon                              Orthostatic hypotension Rare                                  Postural hypotension
Respiratory, thoracic and                  Common                                Nasal congestion, sore throat mediastinal disorders
Uncommon                              Dyspnoea
Very common                           Stomatitis
Gastrointestinal disorders                 Common                                Nausea, constipation, diarrhoea, mouth ulceration
Uncommon                              Dry mouth
Hepato-biliary disordrers                  Uncommon                              Transient rise of serum alanine aminotransferase (ALAT)
Common                                Sweating increased
Skin and subcutaneous tissue               Uncommon                              Hair loss, skin eruptions Rare                                  Skin reactions
Muskuloskeletal and lymphatic              Common                                Arthralgia, back pain, muscle system disorders                                                                 cramps Uncommon                              Myopathy
Renal and urinary disorders                Uncommon                              Micturition disorders Not known                             Urinary retention
General disorders and                      Common                                Fatigue administration site conditions
Uncommon                              Chest pain, irritability, ankle oedema
Injury, poisoning and procedural         Common                                     Fall complications
Investigations                           Common                                     Mild hepatic enzymes increased 

* Parkinson's disease patients treated with dopamine agonists and other dopaminergic treatments have been reported as exhibiting impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, binge eating, shopping and different kinds of compulsive/repetitive activities (punding). These may also be possible with selegiline but very few cases have been reported to date.
As selegiline potentiates the effect of levodopa (levodopa should be usually given in association with a peripheral decarboxylase inhibitor), the side-effects of levodopa may be emphasised unless the dosage of levodopa is reduced.
Selegiline combination therapy may permit further reduction of levodopa dose (even by 30 %). The most common undesirable effect reported for conventional tablets is dyskinesia (4% of patients) other side effects include restlessness, hyperkinesis, abnormal movements, agitation, confusion, hallucination, postural hypotension, cardiac arrhythmias. Once the optimum levodopa dose level has been established, the side-effects produced by the combination will usually be less than those caused by the levodopa therapy on its own.

Reporting of suspected adverse reactions
Side effects can be reported to the Ministry of Health by clicking the link: "Reporting side effects due to drug treatment" found on the home page of the Ministry of Health's website (www.health.gov.il), which links to the online report of adverse effects, or by logging in to the link: https://sideeffects.health.gov.il