System Organ Very Common Uncommon Rare common Class Immune system Drug disorders Metabolism and Decreased appetite nutrition disorders Anxiety, Confusional state, Depressed mood, Thinking Psychiatric disorders Hallucination, Sleep disorder, Disorientation, Agitation, abnormal Abnormal dreams Nervousness, Restlessness, Euphoric mood Nervous system Dizziness, Tremor Disturbance in attention, Convulsion, disorders Somnolence, Memory impairment, Depressed Headache Presyncope, Sedation, Ataxia, level of Dysarthria, Hypoaesthesia, Paraesthesia, Muscle contractions involuntary Coordination abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Heart rate Palpitations decreased Vascular disorders Blood pressure decreased Respiratory depression, Respiratory, Oxygen saturation decreased, thoracic and mediastinal Dyspnoea, disorders Nausea, Constipation, Diarrhoea, Abdominal discomfort Impaired Gastrointestinal Vomiting Dyspepsia, Dry mouth gastric disorders emptying Pruritus, Hyperhidrosis, Rash Urticaria Skin and subcutaneous tissue disorders Muscle spasms Sensation of heaviness Musculoskeletal and connective tissue disorder Urinary hesitation, Renal and urinary Pollakiuria disorders General disorders Asthenia, Fatigue, Feeling of Drug withdrawal syndrome, and administration body temperature change Oedema, Feeling abnormal, Feeling drunk, Irritability, site conditions Feeling of relaxation * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported. Clinical trials performed with PALEXIA with patient exposure up to 90 days have shown little evidence of withdrawal symptoms upon abrupt discontinuations and these were generally classified as mild, when they occurred. Nevertheless, physicians should be vigilant for symptoms of withdrawal (see section 4.2) and treat patients accordingly should they occur. The risk of suicidal ideation and suicides committed is known to be higher in patients suffering from chronic pain. In addition, substances with a pronounced influence on the monoaminergic system have been associated with an increased risk of suicidality in patients suffering from depression, especially at the beginning of treatment. For tapentadol data from clinical trials and post-marketing reports do not provide evidence for an increased risk.
System Organ Class Very common Common Uncommon Rare Immune system disorders Drug Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Anxiety, Confusional state, Hallucination, Sleep disorder, Abnormal dreams Depressed mood, Disorientation, Agitation, Nervousness, Restlessness, Euphoric mood Thinking abnormal Nervous system disorders Dizziness, Somnolence, Headache Tremor Disturbance in attention, Memory impairment, Presyncope, Sedation, Ataxia, Dysarthria, Hypoaesthesia, Paraesthesia, Muscle contractions involuntary Convulsion, Depressed level of Coordination abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Palpitations Heart rate decreased Vascular disorders Blood pressure decreased Respiratory, thoracic and mediastinal disorders Respiratory depression, Oxygen saturation decreased, Dyspnoea, Gastrointestinal disorders Nausea, Vomiting Constipation, Diarrhoea, Dyspepsia, Dry mouth Abdominal discomfort Impaired gastric emptying Skin and subcutaneous tissue disorders Pruritus, Hyperhidrosis, Rash Urticaria Musculoskeletal and connective tissue disorder Muscle spasms Sensation of heaviness Renal and urinary disorders Urinary hesitation, Pollakiuria General disorders and administration site conditions Asthenia, Fatigue, Feeling of body temperature change Drug withdrawal syndrome, Oedema, Feeling abnormal, Feeling drunk, Irritability, Feeling of relaxation * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported. Clinical trials performed with PALEXIA with patient exposure up to 90 days have shown little evidence of withdrawal symptoms upon abrupt discontinuations and these were generally classified as mild, when they occurred. Nevertheless, physicians should be vigilant for symptoms of withdrawal (see section 4.2) and treat patients accordingly should they occur. The risk of suicidal ideation and suicides committed is known to be higher in patients suffering from chronic pain. In addition, substances with a pronounced influence on the monoaminergic system have been associated with an increased risk of suicidality in patients suffering from depression, especially at the beginning of treatment. For tapentadol data from clinical trials and post-marketing reports do not provide evidence for an increased risk.