Atenolol Side Effects

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Answer the side-effect intent for atenolol without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of cardiovascular side effects.

What is atenolol?

Atenolol contains the active ingredient Atenolol.

• Active ingredient — Atenolol
• Registration number — A38/5.2/0501; A38/5.2/0502; A38/5.2/0503
• Registration holder — Austell Laboratories (Pty) Ltd

It is approved for:

• TENOPRESS contains a medicine called atenolol
• Atenolol belongs to a group of medicines called beta- blockers
• TENOPRESS is used in the management of angina pectoris and hypertension

Common side effects of atenolol

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Unusual tiredness or weakness
• Nausea or vomiting
• An upset stomach or stomach pain
• Cold hands and feet
• Low blood pressure (dizziness, tiredness)
• Slow heartbeat

Less frequent side effects

• Depressive mood, confusion, psychoses and hallucinations, mood changes, nightmares and sleep disturbances
• Dizziness, headache and tingling of your hands
• Hearing loss
• Skin rash
• Low blood sugar levels
• Fluid retention and mass gain
• Hair loss
• Dry eyes and vision disturbances
• Being unable to get an erection (impotence)
• Muscle weakness
• Difficulty breathing if you are suffering from asthma or a lung disease
• Reduced number of platelets in your blood (this may make you bruise more easily)
• Purplish marks on your skin
• Heart failure deterioration, worsening of heart block
• Raynaud’s phenomenon (temporary discoloration of the skin and numbness of the fingers or toes)
• Low blood pressure (dizziness, tiredness)
• Dry mouth, constipation
• Changes to some of the cells or other parts of your blood. Your doctor may do blood tests to check if TENOPRESS has had any effect on your blood. Side effects with frequency unknown:
• Constipation
• Lupus-like syndrome (a disease where the immune system produces antibodies that attacks mainly skin and joints)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to atenolol or any of the other ingredients of TENOPRESS (listed in section 6)
• If you have a condition called cardiogenic shock (a condition where the heart is unable to supply enough blood to the organs of the body)
• If you have ever had any of the following heart problems:
• heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
• second- or third-degree heart block (a condition which may be treated by a pacemaker)
• very slow or very uneven heart beats, very low blood pressure or very poor circulation
• If you have a condition called sick sinus syndrome (a group of heart rhythm disorders)
• If you have a tumour called phaeochromocytoma that is not being treated
• This is usually near your kidney and can cause high blood pressure
• If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis)
• If you suffer from bronchospasm or asthma or a history of obstructive airways disease
• If you suffer from heart failure or severe peripheral arterial disease

Use with care, and tell your doctor, if

• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis
• You have first-degree heart block
• You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster
• If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alphablocker, to take as well as TENOPRESS
• You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor
• You have a type of chest pain (angina) called Prinzmetal’s angina
• You have poor blood circulation or controlled heart failure
• Severe peripheral vascular disease (circulation disorder) and a condition called peripheral gangrene may be worsened
• If you are due to have an operation, you should inform your doctor or anaesthetist that you are taking TENOPRESS
• You have problems with your kidneys
• You may need to have some check-ups during your treatment
• If you use medicines for diabetes, phenothiazines (medicine used to treat mental disorders) and antidysrhythmic agents (medicines used to treat abnormal heart rate), you must tell your doctor
• If you are using a medicine called clonidine and are being transferred to TENOPRESS. When stopping clonidine, you may experience extreme high blood pressure. Your doctor will monitor this transfer
• TENOPRESS will reduce your heart rate, if your pulse drops to less than 50 – 55 beats per minute, your dosage should be reduced
• If you have a history of severe allergic reactions to any allergens (example insect stings), as TENOPRESS may cause a more severe reaction and you may be unresponsive to usual doses of medicine (adrenaline) used to treat your allergic reaction
• If you have psoriasis, as TENOPRESS may aggravate your psoriasis (make it worse)
• If you are elderly, as your dosage of TENOPRESS should be reduced. If you are elderly, your doctor will start your treatment with a lesser dose. Children TENOPRESS should not be given to children as safety and efficacy has not been established

Pregnancy and breastfeeding

• TENOPRESS should not be taken by pregnant women and women who are breastfeeding
• TENOPRESS is excreted into breastmilk
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking TENOPRESS

Interactions and medicines to check

The approved leaflet names these interactions.

• Anaesthetic medicines (medicines to sedate you during an operation) such as quinidine, procainamide, lignocaine) should be avoided with TENOPRESS
• Hypoglycaemic agents (oral blood sugar lowering medication or insulin), phenothiazines and Class I antiarrhythmic agents such as disopyramide (used to treat an irregular heartbeat or rapid heartbeat). N.B such medicines can have life threatening consequences
• Verapamil, diltiazem and nifedipine (for high blood pressure and chest pain)
• Digoxin (heart medication). May cause a decrease in your heartbeat, which can be dangerous. Your doctor should monitor your pulse rate and response regularly
• Clonidine (for high blood pressure or migraine). If you are taking clonidine and TENOPRESS together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it
• Medicines called calcium blockers may cause heart failure
• Medicines called verapamil may cause heart failure
• Sympathomimetic agents e.g adrenaline or epinephrine may interfere with TENOPRESS
• Ibuprofen and Indomethacin (medicines used for pain) may interfere with TENOPRESS
• Oral blood sugar lowering medication or insulin

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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