|The most commonly reported undesirable effects during the clinical trials performed with the paracetamol/tramadol combination were nausea, dizziness and somnolence, observed in more than 10 % of the patients. |
Cardiovascular system disorders: • Uncommon (≥ 1/1000 to < 1/100): hypertension, palpitations, tachycardia, arrythmia.
Central and peripheral nervous system disorders: • Very common (≥ 1/10): dizziness, somnolence • Common (≥ 1/100 to < 1/10): headache trembling • Uncommon (≥ 1/1000 to < 1/100): involuntary muscular contractions, paraesthesia, tinnitus• Rare (≥ 1/10000 to < 1/1000): ataxia, convulsions, syncope.
Psychiatric disorders: • Common (≥ 1/100 to < 1/10): confusion, mood changes (anxiety, nervousness, euphoria), sleep disorders • Uncommon (≥ 1/1000 to < 1/100) : depression, hallucinations, nightmares, amnesia• Rare (≥ 1/10000 to < 1/1000): drug dependence.
Post marketing surveillanceVery rare (< 1/10000): abuse.
Vision disorders: • Rare (≥ 1/10000 to < 1/1000): blurred vision
Respiratory system disorders: • Uncommon (≥ 1/1000 to < 1/100): dyspnoea
Gastro-intestinal disorders: • Very common (≥ 1/10) : nausea • Common (≥ 1/100 to < 1/10): vomiting, constipation, dry mouth, diarrhoea abdominal pain, dyspepsia, flatulence • Uncommon (≥ 1/1000 to < 1/100): dysphagia, melaena.
Liver and biliary system disorders: • Uncommon (≥ 1/1000 to < 1/100): hepatic transaminases increase.
Skin and appendages disorders:• Common (≥ 1/100 to < 1/10) : sweating, pruritus• Uncommon (≥ 1/1000 to < 1/100): dermal reactions (e.g.rash, urticaria).
Urinary system disorders:• Uncommon (≥ 1/1000 to < 1/100): albuminuria, micturition disorders (dysuria and urinary retention).
Metabolism and nutrition disorders: • Unknown (cannot be estimated from available data): hypoglycaemia
Body as a whole: • Uncommon (≥ 1/1000 to < 1/100): shivers, hot flushes, thoracic pain.Although not observed during clinical trials, the occurrence of the following undesirable effects known to be related to the administration of tramadol or paracetamol cannot be excluded:
Tramadol• Postural hypotension, bradycardia, collapse (tramadol).• Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times.• Rare cases (≥ 1/10000 to < 1/1000) : allergic reactions with respiratory symptoms (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis• Rare cases (≥ 1/10000 to < 1/1000) : changes in appetite, motor weakness, and respiratory depression• Psychic side-effects may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood, (usually elation occasionally dysphoria), changes in activity (usually suppression occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour perception disorders).• Worsening of asthma has been reported though a causal relationship has not been established.• Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen if tramadol hydrochloride is discontinued abruptly include: panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and unusual CNS symptoms.
Paracetamol• Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.• There have been several reports that suggest that paracetamol may produce hypoprothrombinemia when administered with warfarin-like compounds. In other studies, prothrombin time did not change.• Very rare cases of serious skin reactions have been reported.