Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
Among the most common adverse reactions observed with labetalol tablets and gathered from post- marketing reports are: heart failure, postural hypotension, hypersensitivity, lichenoid eruptions, drug fever, elevated liver function tests, difficulty in micturition, dizziness, headache, tickling sensation on the scalp, blurred vision, nasal congestion, nausea, erectile dysfunction and ejaculatory failure.

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       Very common        Positive antinuclear antibodies not associated with disease
Common             Hypersensitivity, lichenoid eruption,
drug fever
Psychiatric disorders         Uncommon           #Depressed mood
Central and peripheral        Common             #Dizziness, #headache, #tickling nervous system disorders                         sensation on the scalp Very rare          Tremor on treatment of pregnancy related hypertension
Eye disorders                 Common             Blurred vision
Very rare          Eye irritation
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
Gastrointestinal disorders    Common             Nausea
Uncommon           Vomiting, epigastric pain
Hepatobiliary disorders       Common             Elevated liver function tests Very rare          Hepatitis, hepatocellular jaundice,
cholestatic jaundice, hepatic necrosis
Skin and subcutaneous         Uncommon           #Sweats tissue disorders
Musculoskeletal and           Uncommon           Cramps connective tissue disorders   Very rare          Toxic myopathy, systemic lupus erythematosus
Renal and urinary disorders   Common              Difficulty in micturition Very rare           Acute urine retention
Reproductive system and       Common             Erectile dysfunction, ejaculatory failure breast disorders              Not known          Nipple pain, Raynaud's phenomenon of the nipple
General disorders and         Common             #Fatigue, #lethargy administration site           Very rare          # Foot oedema conditions


Description of selected adverse reactions:

Immune system disorders
Hypersensitivity reactions including rash (including reversible lichenoid eruptions), pruritus, dyspnoea and, very rarely, drug fever and angioedema have been reported.
Vascular disorders
Postural hypotension is more common with very high doses or if the starting dose is too high, or the dose is increased too rapidly.
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