Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose.
Blood and lymphatic system disorders
Blood dyscrasias, leucopenia.
Psychiatric disorders
Mild drowsiness*, disorientation, dreams, †nightmares, lethargy, amnesia (see below), mild excitatory effects with stimulation of affect**, numbed emotions, reduced alertness, †restlessness, †agitation, †irritability, †delusions, †rages, †psychoses, †inappropriate behaviour, behavioural adverse effects including paradoxical †aggressive outbursts, excitement, †hallucinations, confusion, uncovering of depression with suicidal tendencies.*** †These are more likely to occur in children and the elderly.
Nervous system disorders
Dizziness, light-headedness*, ataxia, vertigo, headache, syncope, slurred speech, tremor, dysarthria.
Eye disorders
Blurred vision, double vision.
Vascular disorders
Hypotension.
Gastrointestinal disorders
Nausea, salivation changes, gastrointestinal disturbances.
Hepatobiliary disorders
Increased liver enzymes, jaundice.

Skin and subcutaneous tissue disorders
Minor diffuse skin rashes (morbilliform, urticarial and macropapular).
Musculoskeletal and connective tissue disorders
Muscle weakness.
Renal and urinary disorders
Incontinence, urinary retention.
Reproductive system and breast disorders
Altered libido.
General disorders and administration site conditions
Fever, oedema, fatigue.
Injury, poisoning and procedural complications
Fall.
* Commonly seen in the first few days of therapy. If this becomes troublesome dosage should be reduced.
** Reported in psychiatric patients and usually occur within the first few weeks of therapy.
*** Extreme caution should therefore be exercised in prescribing benzodiazepines to patients with personality disorders.
Amnesia
Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
Amnestic effects may be associated with inappropriate behaviour (see section 4.4).


Dependence
When used at the appropriate recommended dosage for short term treatment of anxiety the dependence potential of oxazepam is low. However, the risk of dependence increases with higher doses and longer-term use and is further increased in patients with a history of alcoholism, drug abuse or in patients with marked personality disorders (see section 4.4).

Withdrawal

As with all benzodiazepines, withdrawal may be associated with physiological and psychological symptoms including depression, persistent tinnitus, involuntary movements, paraesthesia, perceptual changes, confusion, convulsions, muscle cramps, abdominal cramps and vomiting.

Symptoms such as anxiety, depression, headache, insomnia, tension and sweating have been reported following abrupt discontinuation of benzodiazepines and these symptoms may be difficult to distinguish from the original symptoms of anxiety.

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/