Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency very common). Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.

Tabulated list of adverse reactions

The following adverse reactions have been reported with Nyxoid and/or other naloxone- containing medicinal products during clinical studies and post marketing experience. ADRs are listed below by system organ class and frequency.

Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as 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
Very rare:               Hypersensitivity, Anaphylactic shock


Nervous system disorders
Common                   Dizziness, Headache

Uncommon                 Tremor

Cardiac disorders
Common                   Tachycardia

Uncommon                 Arrhythmia, Bradycardia

Very rare                Cardiac fibrillation, Cardiac arrest
Vascular disorders

Common                   Hypotension, Hypertension

Respiratory, thoracic and mediastinal disorders

Uncommon                 Hyperventilation

Very rare                Pulmonary oedema
Gastrointestinal disorders
Very common              Nausea
Common                   Vomiting

Uncommon                 Diarrhoea, Dry mouth

Skin and subcutaneous tissue disorders
Uncommon                   Hyperhidrosis
Very rare                Erythema multiforme
General disorders and administration site conditions

Uncommon                 Drug withdrawal syndrome (in patients dependent on opioids) 

Description of selected adverse reactions
Drug withdrawal syndrome

Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia. Behavioural changes including violent behaviour, nervousness and excitement may also be observed.

Vascular disorders

In reports on intravenous/intramuscular naloxone: hypotension, hypertension, cardiac arrhythmia (including ventricular tachycardia and fibrillation) and pulmonary oedema have occurred with the postoperative use of naloxone. Adverse cardiovascular effects have occurred more frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other medicines that produce similar adverse cardiovascular effects.

Paediatric population

Nyxoid is intended for use in adolescents 14 years and over.
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/