Beta blockers Side Effects

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

What is beta blockers?

Beta blockers covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• bisoprolol — ADCO BISOCOR, Adcock Ingram Limited (Film-coated tablets)
• atenolol — TENCHLOR, TENCHLOR HS, PHARMACARE LIMITED (Film-coated tablets)
• carvedilol — CRAVEDON 6,25 mg; 12,5 mg & 25 mg, Smart Pharmaceuticals (Pty) Ltd (Tablet)

Common side effects of beta blockers

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Bisoprolol (ADCO BISOCOR)

• Drowsiness, unusual tiredness or weakness
• Feeling of coldness or numbness in hands or feet
• Low blood pressure (you may feel light-headed)
• Headache, dizziness and extreme tiredness (these may be mild especially at the beginning of therapy and may often disappear within 1-2 weeks)
• Nausea, vomiting, diarrhoea, constipation
• Decreased sexual ability
• Lack of energy
• Confusion, hallucinations, depression, trouble sleeping, nightmares and vivid dreams, anxiety, memory loss and nervousness
• Allergic runny nose, sneezing and itching, nasal congestion, breathing problems in patients with asthma, chronic lung disease or other problems of the airways
• Dry, sore eyes, irritation and redness of the eye (conjunctivitis)
• Reduced tear flow which may lead to problems if you wear contact lenses
• Skin rash, itching of the skin, swelling under skin (angioedema), appearance or worsening of scaly skin rash (psoriasis)

The leaflet lists 21 more. Read the full leaflet.

Atenolol (TENCHLOR, TENCHLOR HS)

• Cold hands and feet
• nausea
• extreme tiredness
• seeing or hearing something that is not really there (hallucinations)
• mood changes, confusion, mental episodes
• dry eyes and disturbance in vision
• disturbances of sleep, including nightmares
• reversible hair loss (alopecia)
• swelling due to retaining fluid
• weight gain
• being unable to get an erection (male impotence)
• headache, “pins and needles” sensation (paraesthesia)

The leaflet lists 24 more. Read the full leaflet.

Carvedilol (CRAVEDON 6,25 mg; 12,5 mg & 25 mg)

• feeling dizzy
• headache
• feeling weak and tired
• low blood pressure. The signs include feeling dizzy or light-headed
• infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat
• infections of the urinary tract which can cause problems in passing water
• low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath
• increase in weight
• increase in cholesterol levels (shown by a blood test)
• loss of control of blood sugar in people with diabetes
• feeling depressed
• problems with your sight, sore or dry eyes due to fewer tears being made

The leaflet lists 29 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

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

Cautions from each medicine’s approved leaflet.

Bisoprolol (ADCO BISOCOR)

Do not use it at all if:

• If you are allergic to bisoprolol or any of the other ingredients of ADCO BISOCOR (listed in section 6)
• If you have severe asthma
• If you have severe blood circulation problem in limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue. S3
• If you have untreated phaeochromocytoma, which is a rare tumour of the adrenal gland (medulla)
• If you have metabolic acidosis, which is a condition when there is too much acid in the blood
• If you have heart failure

Use with care, and tell your doctor, if:

• Do not stop ADCO BISOCOR therapy abruptly, especially if you have coronary heart disease as this may lead to transitional worsening of your heart condition
• If you are due to receive an anaesthetic e.g., before an operation; you should inform the hospital doctor that you are taking ADCO BISOCOR. This medicine may influence how your body react to this situation
• If you suffer from an irregular heartbeat, you experience sudden onset of chest pain, or if you already suffer from a mild form of angina or Prinzmetal’s angina
• If you have any heart problems or first degree heart block (a condition in which nerve signals to the heart are disturbed, possibly causing it occasionally to skip a beat, or beat irregularly)
• If you have liver or kidney problems
• If you are using medicines (verapamil or diltiazem) to treat an irregular heartbeat

Atenolol (TENCHLOR, TENCHLOR HS)

Do not use it at all if:

• if you are hypersensitive (allergic) to atenolol, chlorthalidone, or to any of the other ingredients of TENCHLOR (listed in section 6)
• if you have heart problems such as abnormal heart rhythm where the heart beats too slowly; your heart muscle doesn’t pump blood as well as it should; abnormally slow heart action
• if you suffer from phaeochromocytoma that is not being treated. Phaeochromocytoma is a rare abnormal growth of tissue (tumour) that can form in cells in the middle of the adrenal glands
• if you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis)
• if you have undergone prolonged fasting
• if you are also taking verapamil as neither verapamil nor TENCHLOR should be administered within several days of stopping the other

Use with care, and tell your doctor, if:

• if 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 healthcare provider
• if you have congestive heart failure (a heart condition that causes symptoms of shortness of breath, weakness, fatigue, and swelling of the legs, ankles, and feet)
• if you have a type of chest pain (angina) called Prinzmetal’s angina
• If you have first-degree heart block
• If you have diabetes or if you have gout (hyperuricemia). These conditions may be made worse by TENCHLOR. You should monitor your blood sugar levels regularly. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster
• If you have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis

Carvedilol (CRAVEDON 6,25 mg; 12,5 mg & 25 mg)

Do not use it at all if:

• if you are allergic (hypersensitive) to carvedilol or any of the other ingredients in CRAVEDON listed in section 6
• if you have problems with your heart (for example “heart block”, slow or uneven heart beat)
• if you have low blood pressure
• if you have ever had wheezing due to asthma or other lung diseases
• if you have problems with your liver
• if you have severe fluid retention (swelling of your ankles and feet) CRAVEDON is not suitable for children. Do not take CRAVEDON if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking CRAVEDON

Use with care, and tell your doctor, if:

• you have a problem with acid levels in your blood (metabolic acidosis)
• you have a growth on one of your adrenal glands (phaeochromocytoma)
• you have diabetes (high blood sugar)
• you have ever had problems with your thyroid
• you have problems with your kidneys
• you have ever had a serious allergic reaction (for example, sudden swelling causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash)

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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