Benzodiazepines Side Effects

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

Part of mental health medication side effects side effects.

What is benzodiazepines?

Benzodiazepines 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:

• diazepam — BETAPAM, Ranbaxy Pharmaceuticals (Pty) Ltd (Tablet.)
• lorazepam — ATIVAN INJECTION, PHARMACARE LIMITED (INJECTION)
• alprazolam — Biozane, Biotech Laboratories (Pty) Ltd (Tablets)

Common side effects of benzodiazepines

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.

Diazepam (BETAPAM)

• Feeling tired
• Weak muscles
• Poor co-ordination, including feeling unsteady when you walk
• Slow or slurring of speech
• Headache
• Feeling dizzy
• Uncontrollable movements, for example of your hands (tremor)
• Anterograde amnesia (difficulty remembering new things)
• Confusion
• Depression
• Being less alert
• blood disorders (you may develop sore throats, nose bleeds or infections)

The leaflet lists 31 more. Read the full leaflet.

Lorazepam (ATIVAN INJECTION)

• Drowsiness, sedation
• Tiredness
• Confusion, depression, unmasking of depression
• Lack of muscle coordination, dizziness
• Muscle weakness
• Lack of energy
• Blood disorders which can include lower levels of red blood cells, white blood cells and platelets (known as blood dyscrasias). Symptoms of this include unexplained bruising, bleeding, pale skin, weakness and/or breathlessness, mouth ulcers and/or frequent infections
• Changes in vision
• Nausea, vomiting
• Changes in appetite
• Changes in salivation
• Lack of ability to urinate or involuntary leakage of urine

The leaflet lists 15 more. Read the full leaflet.

Alprazolam (Biozane)

• Lack or loss of appetite
• Confusion, depression, irritability, disorientation, anxiety
• Changes in sexual desire
• Feeling tired, excessive sleeping
• Dizziness, impaired balance, loss of control of full bodily movements (ataxia)
• Headache
• Loss of memory
• Unclear pronouncing of words (dysarthria)
• Lack of energy
• Difficulty in paying attention
• Blurred vision (not seeing clearly)
• Nausea, constipation

The leaflet lists 11 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.

Diazepam (BETAPAM)

Do not use it at all if:

• if you are hypersensitive (allergic) to diazepam or any of the other ingredients of BETAPAM (listed in section 6)
• if you have breathing or lung problems
• if you have severe liver problems
• if you have a condition called “sleep apnoea syndrome” (where your breathing stops when you are asleep)
• if you have a condition called “myasthenia gravis” (where your muscles are weak and get tired easily)
• if you are addicted to CNS depressants (e.g., tranquilisers, sleep medicine) including alcohol

Use with care, and tell your doctor, if:

• if you regularly drink alcohol and/or CNS depressants, or take recreational drugs
• if you have had problems with alcohol or drug abuse in the past
• if you experience total or partial memory loss, memory loss is more likely to occur when taking high doses of BETAPAM
• if you have acute narrow-angle glaucoma (eye disorder where the nerve connecting the eye to the brain is damaged, usually due to high eye pressure)
• if you have liver, kidney, lung or heart problems
• if you have difficulty in swallowing or breathing or suffer from a lung disease called chronic obstructive pulmonary disease

Lorazepam (ATIVAN INJECTION)

Do not use it at all if:

• if you are allergic (hypersensitive) to lorazepam or any of the ingredients contained in ATIVAN INJECTION
• if you have pre-existing central nervous system (CNS) depression (decreased rate of breathing, decreased heart rate and loss of consciousness)
• if you have severe breathing or chest problems
• if you have myasthenia gravis (a disease causing weakened muscles and excessive tiredness)
• if you have serious liver problems
• if you suffer from sleep apnoea (breathing problems when you are asleep)

Alprazolam (Biozane)

Do not use it at all if:

• if you are hypersensitive (allergic) to alprazolam or other similar benzodiazepine medicines or any of the other ingredients of BIOZANE (listed in section 6)
• if you suffer from a condition called schizophrenia
• if you are taking antiretroviral protease inhibitors used in the treatment of HIV and medication such as ketoconazole, itraconazole or similar medicine to treat fungal infections
• if you are below the age of 18 years
• if you suffer from a disease called ‘myasthenia gravis’ where you suffer from very weak and tired muscles
• if you suffer from severe chest problems or breathing difficulties

Use with care, and tell your doctor, if:

• if you suffer from certain types of depression
• if you have abused drugs or alcohol in the past, or find it difficult to stop taking medicines, drinking alcohol or taking drugs
• when stopping BIOZANE too quickly or abruptly – you may experience withdrawal symptoms like inability to sleep, stomach or muscle cramps, vomiting, sweating, convulsions/seizures
• if you stop BIOZANE too quickly, there is a risk that the symptoms that has led to the treatment of BIOZANE may reoccur in an enhanced form. It is therefore recommended that the dosage is decreased gradually
• if you have problems with your lungs, kidneys or liver
• you should not take BIOZANE if you are psychotic or suffer from mental depression unless you are very anxious

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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