Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following frequency terminology is used:
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: Allergic reactions (urticaria, rhinitis, dyspnoea, Quincke’s oedema), anaphylactic shock.

Nervous system disorders
Common: Dizziness, headache;
Uncommon: Tremor, sweating;
Rare: Seizures, tension.

Seizures have occurred rarely following administration of naloxone hydrochloride; however, a causal relationship to the drug has not been established. Higher than recommended dosage in postoperative use can lead to tension.

Cardiac disorders
Common: Tachycardia;
Uncommon: Arrhythmia, bradycardia;
Very rare: Fibrillation, cardiac arrest.

Vascular disorders
Common: Hypotension, hypertension.


Hypotension, hypertension and cardiac arrhythmia (including ventricular tachycardia and fibrillation) have also occurred with the postoperative use of naloxone hydrochloride. Adverse cardiovascular effects have occurred most frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other drugs that produce similar adverse cardiovascular effects.

Respiratory, thoracic and mediastinal disorders
Very rare: Pulmonary oedema.

Pulmonary oedema has also occurred with the postoperative use of naloxone hydrochloride.
Gastrointestinal disorders
Very common: Nausea;
Common: Vomiting;
Uncommon: Diarrhoea, dry mouth.

Nausea and vomiting have been reported in postoperative patients who have received doses higher than recommended. However, a causal relationship has not been established, and the symptoms may be signs of too rapid antagonisation of the opioid effect.

Skin and subcutaneous tissue disorders
Very rare: Erythema multiforme.

One case of erythema multiforme cleared promptly after naloxone hydrochloride was discontinued.
General disorders and administration site conditions
Common: Postoperative pain;
Uncommon: Hyperventilation, irritation of vessel wall (after i.v. administration); local irritation and inflammation (after i.m. administration).

Higher than recommended dosage in postoperative use can lead to the return of pain. A fast reversal of opioid effect can induce hyperventilation.

Chills, agitation and anxiety have sometimes been reported.

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