Xanax Side Effects

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Answer the side-effect intent for xanax 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 Xanax?

Xanax contains the active ingredient Alprazolam.

• Active ingredient — Alprazolam
• Registration number — 28/2.6/0001; 28/2.6/0002
• Registration holder — Biotech Laboratories (Pty) Ltd

It is approved for:

• BIOZANE is a tranquilliser containing the active ingredient alprazolam
• Alprazolam belongs to a group of medicines called benzodiazepines
• Benzodiazepines affect chemical activity in the brain to promote sleep and reduce anxiety and worry
• BIOZANE tablets are used for the short-term relief of symptoms of anxiety

Common side effects of Xanax

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

• 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
• Dry mouth

Less frequent side effects

• Aggressive behaviour, inability to sleep, mood changes, nervousness, hallucinations, irritability, anger
• Lack of memory, shakiness, slurred speech, concentration difficulties
• Eye pain
• Diarrhoea and vomiting
• Abnormal liver function
• Skin irritation
• Muscle twitching or weakness
• Changes in urinary frequencies
• Changes in menstrual period, sexual disfunction
• Changes in weight

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 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
• if you suffer from sleep apnoea – your breathing stops and starts while you sleep
• if you suffer from severe liver problems

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
• elderly and debilitated patients should be very careful when taking BIOZANE as they are at increased risks of sleepiness, breathing difficulties and the loss of control of bodily movements
• if you suffer from panic disorders associated with a certain type of depression taking BIOZANE may expose suicidal thoughts or plans
• taking BIOZANE together with pain medication containing a certain type of ingredient called opioids can cause sleepiness, ineffective breathing, coma and death. If it can not be avoided to take these two types of medication together, the lowest effective dose of the pain medication should be used and the duration of the treatment should be as short as possible
• taking benzodiazepines such as BIOZANE can cause a decreased ability to remember new information which may result in limited or total inability to remember events and it is therefore necessary to have uninterrupted sleep of 7-8 hours after taking this medication
• if you take benzodiazepines such as BIOZANE, psychiatric reactions and reactions such as, restlessness, irritability, aggressiveness, hallucinations and inappropriate behaviour may occur
• This is more like to occur in children and elderly patients. Should this occur, the use of BIOZANE should be stopped. Children Do not give BIOZANE to children under the age of 18 years

Pregnancy and breastfeeding

• 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 healthcare provider for advice before taking this medicine
• Do not take BIOZANE if you are pregnant or breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• Alcohol and other central nervous system depressants
• Antidepressant medicine e.g., imipramine and desimipramine, fluoxetine, sertraline
• Reduce the dose of BIOZANE if you are taking medication such as fluvoxamine (to treat depression) and cimetidine (to treat stomach ulcers)
• Oral contraceptives
• Diltiazem (blood pressure medicine)
• Antibiotic such as erythromycin
• Pain medication that contains opioids
• Antifungal medicine (ketoconazole, itraconazole)
• HIV medicine (e.g., ritonavir)
• Digoxin (used to treat heart conditions) BIOZANE with alcohol It is important not to drink any alcohol while you are taking BIOZANE, as alcohol increases the effects of the medicine

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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