Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile
The most common undesirable effects observed with labetalol injection, and collected from post- marketing reports include: congestive heart failure, postural hypotension, hypersensitivity, drug fever, raised liver function tests, nasal congestion, and erectile dysfunction.

Tabulated list of adverse reactions
The following convention has been used for the classification of frequency: Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1000 and <1/100
Rare ≥1/10,000and <1/1000
Very rare <1/10,000
Not known (cannot be estimated from the available data)

Side-effects indicated by a hash (#) are usually transient and occur during the first few weeks of treatment.


System organ class                              Side effects
Immune System Disorders        Common           Hypersensitivity, Drug fever Cardiac Disorders              Common           Congestive heart failure Rare             Bradycardia
Very rare        Heart block
Vascular Disorders             Common           #Postural Hypotension Very rare        Exacerbation of the of Raynaud's
Syndrome
Respiratory, Thoracic and      Common           # Nasal Congestion
Mediastinal disorders
Uncommon         Bronchospasm
Hepatobiliary Disorders        Common           Raised 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 reported include rash, pruritus, dyspnoea and very rarely drug fever and angioedema.

Vascular disorders
Pronounced postural hypotension may occur if patients are allowed to assume the upright position within 3 h of receiving labetalol injection.

Hepatobiliary disorders
The signs and symptoms of hepatobiliary disorders are usually reversible on withdrawal of the medicinal product.

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 .