Medikinet Adverse Reactions

The listing 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. The listing is based on data for children, adolescents and adults.
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: leukopenia, thrombocytopenia, anaemia, thrombocytopenic purpura.
Unknown: pancytopenia.
Immune system disorders: Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus^*, rashes and eruptions^*.
Metabolism and nutritional disorders^*: Very common: decreased appetite^**.
Common: anorexia, moderate reduction in weight and height gain during prolonged use in children^*.
Psychiatric disorders^*: Very common: insomnia, nervousness.
Common: abnormal behaviour, aggression^*, affect lability, agitation^*, anorexia, anxiety^*, depression^*, irritability, restlessness^**, sleep disorder^**, libido decrease^***, panic attack^***, stress^***, bruxism^***.
Uncommon: hypervigilance, auditory, visual, and tactile hallucinations^*, mood changes, mood swings, anger, suicidal ideation^*, tearfulness, psychotic disorders^*, tics^* or worsening of pre-existing tics or Tourette's syndrome^*, 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, logorrhea.
Cases of abuse and dependence have been described, more often with immediate-release formulations (frequency not known).
Nervous system disorders: Very common: headache.
Common: tremor^**, somnolence, dizziness, dyskinesia, psychomotor hyperactivity.
Uncommon: sedation, 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, paresthesia^$, aphasia^$, dysphemia.
Eye disorders: Uncommon: diplopia, blurred vision.
Rare: difficulties in visual accommodation, mydriasis, visual disturbance.
Not known: dry eye^$, ocular hypertension.
Cardiac disorders^*: Common: tachycardia^**, palpitations, arrhythmias.
Uncommon: chest pain.
Rare: angina pectoris.
Very rare: cardiac arrest, myocardial infarction.
Not known: supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles, cardiac discomfort^$.
Vascular disorders^*: Common: hypertension, peripheral coldness^**.
Very rare: cerebral arteritis and/or occlusion, Raynaud's phenomenon.
Not known: hot flushing^$, flushing^$.
Respiratory, thoracic, and mediastinal disorders: Common: cough, pharyngolaryngeal pain, dyspnoea^**.
Not known: oropharyngeal pain^$, epistaxis^$.
Gastrointestinal disorders: Very common: nausea^**, dry mouth^**.
Common: abdominal pain, diarrhoea, stomach discomfort, and vomiting: - these usually occur at the beginning of treatment and may be alleviated by concomitant food intake, dyspepsia^***, toothache^***.
Uncommon: constipation.
Not known: retching^$.
Hepatobiliary disorders: Uncommon: hepatic enzyme elevations.
Very rare: abnormal liver function, including hepatic coma.
Skin and subcutaneous tissue disorders: Common: hyperhidrosis^**, alopecia, pruritus, rash, urticaria.
Uncommon: angioneurotic oedema, bullous conditions, exfoliative conditions.
Rare: macular rash, erythema.
Very rare: erythema multiforme, exfoliative dermatitis, fixed drug eruption.
Not known: dry skin.
Musculoskeletal, connective tissue and bone disorders: Common: arthralgia.
Uncommon: myalgia, muscle twitching, muscle tightness^***.
Very rare: muscle cramps.
Not known: trismus^***.
Renal and urinary disorders: Uncommon: haematuria.
Not known: incontinence.
Reproductive system and breast disorders: Rare: gynaecomastia.
Not known: erectile dysfunction, priapism, erection increased and prolonged erection, breast pain^$.
General disorders and administration site conditions: Common: pyrexia, growth retardation during prolonged use in children^*, feeling of inner restlessness^***, fatigue^**, thirst^**.
Very rare: sudden cardiac death^*.
Not known: hyperpyrexia, disturbance in attention^$, influenza like illness^$, asthenia^$, thirst^$, chest discomfort.
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.
Social circumstances: Not known: partner stress^$, family stress^$.
Ear and labyrinth disorders: Not known: tinnitus^$.
^*See Precautions.
^** ADRs from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents.
^*** Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies).
^$ Frequency derived from clinical trials in adult patients but may be also relevant for children and adolescents.