Medikinet Adverse Reactions

The information as follows 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 frequencies of ADRs observed with MEDIKINET MR and other methylphenidate hydrochloride formulations were different, the highest frequency of both databases was used.
Frequency estimate: 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 estimated from the available data).
Infections and infestations: Common: nasopharyngitis.
Uncommon: gastroenteritis.
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, panic attack**, stress**, bruxism^∞.
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, tension**.
Rare: mania*, disorientation, libido disorder.
Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy, repetitive behaviours, over-focusing.
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, akathisia**.
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, dysphemia.
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, dyspepsia**, toothache**.
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, hyperhidrosis^$.
Uncommon: angioneurotic oedema, bullous conditions, exfoliative conditions.
Rare: 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, muscle tightness**.
Very rare: muscle cramps.
Not known: trismus^∞.
Renal and urinary disorders: Uncommon: haematuria.
Not known: incontinence.
Reproductive system and breast disorders: Rare: Gynaecomastia, menstruation disorder^#, impairment of libido^#.
Not known: Menstruation disturbances.
General disorders and administration site conditions: Common: pyrexia, growth retardation during prolonged use in children*.
Uncommon: chest pain, fatigue, thirst**.
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 Precautions.
** ADRs from clinical trials in adult patients that were not reported in children and adolescents.
# Frequency derived from clinical trials in adult patients but may be also relevant for children and adolescents.
$ ADR from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents.
∞ Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies).