Summary of the safety profile Dyskinesia was the most common adverse reaction reported in safinamide patients when used in combination with L-dopa alone or in combination with other PD treatments. Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
With MAO inhibitors there have been reports of drug interactions with concomitant use of sympathomimetic medicinal products. Impulse control disorders; pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Tabulated list of adverse reactions The tabulation below includes all adverse reactions in clinical trials where adverse reactions were considered related. Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System Organ Class Very common Common Uncommon Rare Infections and infestations Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection Neoplasms benign, malignant and unspecified (incl.
cysts and polyps) Basal cell carcinoma Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma Blood and lymphatic system disorders Anaemia, leukopenia, red blood cell abnormality Eosinophilia, lymphopenia Metabolism and nutrition disorders Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia Cachexia, hyperkalaemia Psychiatric disorders Insomnia Hallucination, depression, abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder Compulsions, delirium, disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation System Organ Class Very common Common Uncommon Rare Nervous system disorders Dyskinesia somnolence, dizziness, headache, Parkinson' s disease Paraesthesia, balance disorder, hypoaesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder Coordination abnormal, disturbance in attention, dysgeusia, hyporeflexia, radicular pain, Restless Legs Syndrome, sedation Eye disorders Cataract Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations, tachycardia, sinus bradycardia, arrhythmia Myocardial infarction Vascular disorders Orthostatic hypotension Hypertension, hypotension, varicose vein Arterial spasm, arteriosclerosis, hypertensive crisis Respiratory, thoracic and mediastinal disorders Cough, dyspnoea, rhinorrhoea Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm Gastrointestin al disorders Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, Peptic ulcer, retching, upper gastrointestinal haemorrhage System Organ Class Very common Common Uncommon Rare gastritis, flatulence, abdominal distension, salivary hypersecretion, gastrooesophageal reflux disease, aphthous stomatitis Hepatobiliary disorders Hyperbilirubinaemia Skin and subcutaneous tissue disorders Hyperhidrosis, pruritus generalized, photosensitivity reaction, erythema Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis Musculoskelet al and connective tissue disorders Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst Renal and urinary disorders Nocturia, dysuria Micturition urgency, polyuria, pyuria, urinary hesitation Reproductive system and breast disorders Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain General disorders and administration site conditions Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot Drug effect decreased, drug intolerance, feeling cold, malaise, pyrexia, xerosis System Organ Class Very common Common Uncommon Rare Investigations Weight decreased, weight increased, blood creatine phosphokinase increased, blood triglycerides increased, blood glucose increased, blood urea increased, blood alkaline phosphatase increased, blood bicarbonate increased, blood creatinine increased, electrocardiogram QT prolonged, liver function test abnormal, urine analysis abnormal, blood pressure increased, blood pressure decreased, ophthalmic diagnostic procedures abnormal Blood calcium decreased, blood potassium decreased, blood cholesterol decreased, body temperature increased, cardiac murmur, cardiac stress test abnormal, haematocrit decreased, haemoglobin decreased, international normalised ratio decreased, lymphocyte count decreased, platelet count decreased, very low density lipoprotein increased Injury, poisoning and procedural complications Fall Foot fracture Contusion, fat embolism, head injury, mouth injury, skeletal injury Social circumstances Gambling Description of selected adverse reactions Dyskinesia occurred early in treatment, was rated […]