Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most common adverse reactions observed with labetalol for injection and gathered from post-marketing reports include: heart failure, postural hypotension, hypersensitivity, drug fever, elevated liver function tests, nasal congestion and erectile dysfunction.

Tabulated list of adverse reactions

The following convention has been used to classify the frequency:
Very common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1,000 to <1/100
Rare ≥1/10,000 to <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
The adverse reactions marked with # are usually transient and occur during the first few weeks of treatment.

Organ system                                    Adverse reactions
Immune system disorders        Common           Hypersensitivity, drug fever Cardiac disorders              Common           Heart failure
Rare             Bradycardia
Very rare        Heart block
Vascular disorders             Common           #Postural hypotension Very rare        Aggravated symptoms of Raynaud syndrome
Respiratory, thoracic and      Common           #Nasal congestion mediastinal disorders
Uncommon         Bronchospasm
Hepatobiliary disorders        Common           Elevated liver function tests Very rare        Hepatitis, hepatocellular jaundice,
cholestatic jaundice, hepatic necrosis
Reproductive system and        Common           Erectile dysfunction breast disorders               Not known        Nipple pain, Raynaud’s phenomenon of the nipple



Description of selected adverse reactions:

Immune system disorders
Hypersensitivity reactions including rash, pruritus, dyspnoea and, very rarely, drug fever and angioedema have been reported.

Vascular disorders
Pronounced postural hypotension can occur if patients are permitted to assume an upright position within 3 hours after receiving a labetalol injection.
Hepatobiliary disorders
Signs and symptoms of hepatic and biliary passage disturbances are usually reversible on discontinuation of the drug.

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/ Additionally, you can also report to Padagis via the following address: Padagis.co.il