Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with MEDIKINET MR and those, which have been reported with other methylphenidate hydrochloride formulations. If the ADRs with MEDIKINET MR and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
Frequency estimate: 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) not known (cannot be estimated from the available data).


Infections and infestations
Common: nasopharyngitis
Blood and lymphatic disorders
Very rare: anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura Unknown: pancytopenia
Immune system disorders
Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritis, rashes and eruptions
Metabolism and nutritional disorders*
Common: anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children*
Psychiatric disorders*
Very common: insomnia, nervousness
Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Uncommon: psychotic disorders*, auditory, visual and tactile hallucinations*, anger, suicidal ideation*, mood altered, mood swings, restlessness, tearfulness, tics*, worsening of pre-existing tics or Tourette’s syndrome*, hypervigilance, sleep disorder
Rare: mania*, disorientation, libido disorder
Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy, repetitive behaviours, over-focussing
Not known: delusions*, thought disturbances*, confusional state, dependence Cases of abuse and dependence have been described, more often with immediate-release formulations (frequency not known).
Nervous system disorders
Very common: headache
Common: dizziness, dyskinesia, psychomotor hyperactivity, somnolence
Uncommon: sedation, tremor
Very rare: convulsions, choreo-athetoid movements, reversible ischaemic neurological deficit Neuroleptic malignant syndrome (NMS; Reports were poorly documents and in most of cases, patients were also receiving other drugs, so the role of methylphenidate is unclear.) Not known: cerebrovascular disorders* (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsions*, migraine
Eye disorders
Uncommon: diplopia, blurred vision
Rare: difficulties in visual accommodation, mydriasis, visual disturbance Cardiac disorders*
Common: arrhythmia, tachycardia, palpitations
Uncommon: chest pain
Rare: angina pectoris
Very rare: cardiac arrest, myocardial infarction
Not known: supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles Vascular disorders*
Common: hypertension
Very rare: cerebral arteritis and/or occlusion, peripheral coldness, Raynaud's phenomenon Respiratory, thoracic and mediastinal disorders
Common: cough, pharyngolaryngeal pain
Uncommon: dyspnoea
Gastrointestinal disorders
Common: abdominal pain, diarrhoea, nausea, stomach discomfort and vomiting: - These usually occur at the beginning of treatment and may be alleviated by concomitant food intake.
Dry mouth
Uncommon: constipation
Hepatobiliary disorders
Uncommon: hepatic enzyme elevations
Very rare: abnormal liver function, including hepatic coma
Skin and subcutaneous tissue disorders
Common: alopecia, pruritus, rash, urticaria
Uncommon: angioneurotic oedema, bullous conditions, exfoliative conditions Rare: hyperhidrosis, macular rash, erythema
Very rare: erythema multiforme, exfoliative dermatitis, fixed drug eruption Not known: dry skin
Musculoskeletal, connective tissue and bone disorders
Common: arthralgia
Uncommon: myalgia, muscle twitching
Very rare: muscle cramps
Renal and urinary disorders
Uncommon: haematuria
Reproductive system and breast disorders
Rare: gynaecomastia
General disorders and administration site conditions
Common: pyrexia, growth retardation during prolonged use in children* Uncommon: chest pain, fatigue
Very rare: sudden cardiac death*
Not known: chest discomfort, hyperpyrexia
Investigations
Common: changes in blood pressure and heart rate (usually an increase)*, weight decreased* Uncommon: cardiac murmur*, hepatic enzyme increased
Very rare: blood alkaline phosphatase increased, blood bilirubin increased, platelet count decreased, white blood count abnormal
*see section 4.4