Frequency System Organ Very common Common Uncommon Rare Class Drug hypersensitivity* Immune system disorders Metabolism and Decreased appetite Weight decreased nutrition disorders Psychiatric Anxiety, Depressed mood, Disorientation, Confusional Drug disorders Sleep disorder, state, Agitation, Perception dependence, Nervousness, Restlessness disturbances, Abnormal Thinking dreams, Euphoric mood abnormal Nervous system Dizziness, Disturbance in attention, Depressed level of Convulsion, disorders Somnolence, Tremor, Muscle consciousness, Memory Presyncope, Headache contractions involuntary impairment, Mental Coordination impairment, Syncope, abnormal Sedation, Balance disorder, Dysarthria, Hypoaesthesia, Paraesthesia Visual disturbance Eye disorders Cardiac disorders Heart rate increased, Heart rate decreased, Palpitations Vascular disorders Blood pressure decreased Respiratory, Dyspnoea Respiratory thoracic and depression mediastinal disorders Gastrointestinal Nausea, Vomiting, Diarrhoea, Abdominal discomfort Impaired disorders Constipation Dyspepsia gastric emptying Skin and Pruritus, Hyperhidrosis, Urticaria subcutaneous tissue Rash disorders Urinary hesitation, Renal and urinary disorders Pollakiuria Sexual dysfunction Reproductive system and breast disorders Asthenia, Fatigue, Feeling Drug withdrawal syndrome, Feeling drunk, General disorders of body temperature Feeling abnormal, Feeling of and administration change, Mucosal dryness, Irritability relaxation site conditions Oedema * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported. Clinical trials performed with PALEXIA SR with patient exposure up to 1 year 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 Frequency Very common Common Uncommon Rare Immune system disorders Drug hypersensitivity* Metabolism and nutrition disorders Decreased appetite Weight decreased Psychiatric disorders Anxiety, Depressed mood, Sleep disorder, Nervousness, Restlessness Disorientation, Confusional state, Agitation, Perception disturbances, Abnormal dreams, Euphoric mood Drug dependence, Thinking abnormal Nervous system disorders Dizziness, Somnolence, Headache Disturbance in attention, Tremor, Muscle contractions involuntary Depressed level of consciousness, Memory impairment, Mental impairment, Syncope, Sedation, Balance disorder, Dysarthria, Hypoaesthesia, Paraesthesia Convulsion, Presyncope, Coordination abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Heart rate decreased, Palpitations Vascular disorders Blood pressure decreased Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Nausea, Constipation Vomiting, Diarrhoea, Dyspepsia Abdominal discomfort Impaired gastric emptying Skin and subcutaneous tissue disorders Pruritus, Hyperhidrosis, Rash Urticaria Renal and urinary disorders Urinary hesitation, Pollakiuria Reproductive system and breast disorders Sexual dysfunction General disorders and administration site conditions Asthenia, Fatigue, Feeling of body temperature change, Mucosal dryness, Oedema Drug withdrawal syndrome, Feeling abnormal, Irritability Feeling drunk, Feeling of relaxation * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported. Clinical trials performed with PALEXIA SR with patient exposure up to 1 year 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.