Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see Section 4.4). Constipation may be prevented with an appropriate laxative. If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic.
The following frequency categories form the basis for classification of the undesirable effects: 


Immune system disorders:
Uncommon: hypersensitivity
Frequency not known: anaphylactic reaction, anaphylactoid reaction.
Metabolism and nutrition disorders:
Common: decreased appetite.
Uncommon: dehydration.
Psychiatric disorders:
Common: anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams.
Uncommon: agitation, affect lability, euphoric mood, hallucinations, decreased libido, drug dependence (see section 4.4), disorientation, mood altered, restlessness, dysphoria Frequency not known: aggression.
Nervous system disorders:
Very common: somnolence, dizziness, headache.
Common: tremor, lethargy, sedation.
Uncommon: amnesia, convulsion, hypertonia, hypoaesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.
Frequency not known: hyperalgesia.
Eye disorders:
Uncommon: visual impairment, miosis.
Ear and labyrinth disorders:
Uncommon: vertigo.
Cardiac disorders:
Uncommon: palpitations (in the context of withdrawal syndrome), supraventricular tachycardia.
Vascular disorders:
Uncommon: vasodilatation, facial flushing.
Rare: hypotension, orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea, bronchospasm, cough decreased.
Uncommon: respiratory depression, hiccups.


Gastrointestinal disorders:
Very common: constipation, nausea, vomiting.
Common: abdominal pain, diarrhoea, dry mouth, dyspepsia.
Uncommon: dysphagia, flatulence, eructation, ileus, gastritis.
Frequency not known: dental caries.
Hepato-biliary disorders:
Uncommon: increased hepatic enzymes, biliary colic.
Frequency not known: cholestasis.
Skin and subcutaneous tissue disorders:
Very common: pruritus.
Common: rash, hyperhidrosis.
Uncommon: dry skin, exfoliative dermatitis.
Rare: urticaria.
Renal and urinary disorders:
Uncommon: urinary retention, ureteral spasm.
Reproductive system and breast disorders:
Uncommon: erectile dysfunction, hypogonadism.
Frequency not known: amenorrhoea.
General disorders and administration site conditions:
Common: asthenia, fatigue.
Uncommon: drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, pyrexia, chills.
Frequency not known: drug withdrawal syndrome neonatal.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il