Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most commonly reported undesirable effects, nausea and dizziness, have been observed in more than 10% of patients.

The frequencies are defined as follows:
Very common:                    ≥1/10
Common:                         ≥1/100, <1/10
Uncommon:                       ≥1/1,000, <1/100
Rare:                           ≥1/10,000, <1/1,000
Very rare:                      <1/10,000
Not known:                      cannot be estimated from the available data 

Immune system disorders
Rare: allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioedema) and anaphylactic reaction.

Metabolism and nutrition disorders
Rare: appetite disorder.
Not known: hypoglycemia.

Psychiatric disorders
Rare: hallucinations, confusional state, sleep disturbance, nightmares, anxiety, delirium.
After the administration of tramadol, in rare cases, various psychiatric adverse events may occur, the nature and severity of which vary between patients (depending on the individual reactivity and the duration of treatment). Mood disorders (usually euphoria, occasionally dysphoria), changes in activity (usually reduced activity, occasionally an increase) and, altered cognitive and sensory capacities (for example the ability to make decisions, perception problems) may be observed. Dependence may occur.

Symptoms of drug withdrawal syndrome, similar to those observed during withdrawal of opiates may occur, such as agitation, anxiety, nervousness, insomnia, hyperkinesias, tremor, and gastro-intestinal symptoms. Other symptoms of withdrawal have also been reported, including: panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and other CNS problems

Nervous system disorders
Very common: dizziness.
Common: headaches, somnolence
Rare: paraesthesia, tremor, convulsions.
Not known: serotonin syndrome
Convulsions primarily occurred following administration of high doses of tramadol or following concomitant treatment with medicinal products that lower the seizure threshold or trigger seizures (see sections 4.4 and 4.5).

Eye disorders
Rare: vision blurred, miosis.

Cardiac disorders
Uncommon: effects on cardiovascular regulation (palpitations, tachycardia). These undesirable effects occur in particular after intravenous administration and in patients undergoing physical exertion.
Rare: bradycardia.

Vascular disorders
Uncommon: effects on cardiovascular regulation (orthostatic hypotension or circulatory collapse). These undesirable effects occur in particular after intravenous administration and in patients undergoing physical exertion.

Respiratory, thoracic and mediastinal disorders
Rare: respiratory depression.
Respiratory depression may occur if the quantities administered greatly exceed the recommended doses and in the case of concomitant administration of other CNS depressant medicinal products (see section 4.5).
Unknown: Hiccups
An aggravation of asthma has been reported although a causal relationship was not confirmed.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: gastrointestinal tract irritation (abdominal discomfort, flatulence).
Hepatobiliary disorders
In some isolated cases, an increase in hepatic enzymes was reported during the therapeutic use of tramadol.
Skin and subcutaneous tissue disorders
Common: hyperhidrosis.
Uncommon: skin reaction (for example pruritus, rash, urticaria).
Musculoskeletal and connective tissue disorders
Rare: muscular weakness.
Renal and urinary disorders
Rare: micturation problems (dysuria and urinary retention).
General disorders and administration site conditions
Common: fatigue.
Investigations
Rare: blood pressure increased.

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 https://sideeffects.health.gov.il