The most frequent adverse reactions are nausea and dizziness, noted in more than 10% of patients.
The frequency is defined as follows:
Often: >1/10;
Often: >1/100, <1/10;
Infrequently: >1/1000, <1/100;
Rarely: >1/10 000, <1/1000;
Very rarely: <1/10 000;
Frequency is unknown: can not be determined on the basis of available data.
Heart Disease:
Infrequently: influence on cardiovascular regulation (palpitation, tachycardia). These undesirable reactions are mainly observed with intravenous administration of the drug or with significant physical exertion.
Rarely: aetiology.
Vascular disorders:
Infrequently: effects on cardiovascular regulation (orthostatic hypotension or collapse). These undesirable reactions are mainly observed with intravenous administration of the drug or with significant physical exertion.
Disorders from the metabolism and nutrition:
Rarely: changes in appetite.
Disturbances from the respiratory system, chest and mediastinal organs:
Rarely: respiratory depression, shortness of breath.
At a significant excess recommended doses with simultaneous application of other drugs,
oppressing the central nervous system (CNS), possible respiratory depression. There was a deterioration in bronchial asthma, but there was no causal relationship with the drug.
Impaired nervous system:
Very often: dizziness.
Often: headache, drowsiness.
Rarely: speech disorders, paresthesia, tremor, epileptiform seizures, involuntary muscle contractions, coordination disorders, fainting. Epileptiform seizures are possible after applying high doses of tramadol and with simultaneous use with drugs that lower the threshold of convulsive readiness.
Disorders of the psyche:
Rarely: hallucinations, confusion, sleep disturbances, anxiety, delirium and nightmares. After the use of tramadol, various rarely observed undesirable reactions from the psyche are possible (depending on the personality characteristics of the patient and the duration of treatment). These unwanted reactions include mood changes (usually euphoria, sometimes dysphoria), changes in activity (usually a decrease, sometimes an increase), impairment of cognitive functions and perception (eg, decision-making, perceptual disorders). Perhaps the development of drug dependence. Possible symptoms of "cancellation" are similar to the symptoms of opioid withdrawal: agitation, anxiety, nervousness, sleep disorders, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that are very rare with tramadol cancellation include: panic attacks, severe anxiety, hallucinations, paresthesia, ringing in the ears and other symptoms from the side of the central nervous system (confusion, hallucinations, depersonalization, derealization, paranoia).
Disorders from the side of the organ of vision:
Rarely: miosis, mydriasis, blurred vision.
Disorders from the gastro-intestinal tract:
Very often: nausea.
Often: constipation, dry mouth, vomiting.
Infrequent: vomiting, gastrointestinal,intestinal symptoms (eg, pain in the belly, bloating), diarrhea.
Disturbances from the skin and subcutaneous fabrics:
Often: sweating.
Infrequently: skin reactions (eg, itching, redness, hives).
Disorders from the side of the skeletal-muscular and connective tissue:
Rarely: muscle weakness.
Disorders from the liver and bile ducts:
In some cases, it was noted increased activity of liver enzymes, on time coinciding with therapy
tramadol.
Infringements from kidneys and urinary tract:
Rarely: urinary disorders (dysuria and urine retention).
Immune system disorders:
Rarely: allergic reactions (dyspnea, bronchospasm, wheezing, angioedema) and anaphylaxis.
General disorders and disorders at the site of administration:
Often: fatigue.
Laboratory and instrumental data:
Rarely: increased blood pressure.
Frequency unknown: hypoglycaemia.
If undesired reactions appear in the manual, or if other undesirable reactions are noted that are not listed in the instructions, tell your doctor.