Trazodone Side Effects

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Answer the side-effect intent for trazodone 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 trazodone?

Trazodone contains the active ingredient Trazodone hydrochloride.

• Active ingredient — Trazodone hydrochloride
• Registration number — 43/1.2/0698; 43/1.2/0699
• Registration holder — Biotech Laboratories

It is approved for:

• Depression
• Mixed anxiety and depression

Common side effects of trazodone

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

• headache
• dizziness
• drowsiness
• nausea
• vomiting
• dry mouth, an unpleasant taste

Less frequent side effects

• confusion
• unusual excitement
• low blood pressure
• tremors
• blurred vision
• constipation
• diarrhoea

Frequency not known side effects

• feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• body is retaining water due to high levels of a hormone (SIADH)
• weight loss and loss of appetite
• increased appetite
• feeling tired, weak and confused, having muscle that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood
• convulsions
• thoughts of harming or killing yourself
• feeling anxious or more nervous than usual, feeling agitated
• overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
• spinning feeling (vertigo)
• nightmares
• decreased sex drive
• decreased alertness
• jerking movements that you cannot control, mainly in of the arms and legs, uncontrolled muscle movements or twitches
• difficulty with speaking
• feeling very unwell possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching, and a high temperature (above 36 °C). This could be a rare condition known as Neuroleptic Malignant Syndrome
• unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• muscle tremors
• abnormal muscle tone and posture
• restlessness
• irritability
• sleeplessness
• slow heartbeat
• feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension), fainting (syncope)
• high blood pressure
• blocked nose
• indigestion
• stomach pain
• infectious diarrhoea
• increased amounts of saliva
• severe liver disorders such as severe liver function impairment or hepatitis
• liver failure with potentially fatal outcome
• sweating more than usual
• pain in limbs, back pain, pain in your muscles, pain in your joints
• disturbances of emptying of the bladder
• weakness
• water retention which may cause swollen arms or legs
• high temperature
• flu type symptoms
• chest pain
• tiredness
• high levels of liver enzymes in your blood (shown by a blood test)

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 trazodone hydrochloride or any of the other ingredients of BIOTECH TRAZODONE (listed in section 6)
• if you are recovering from a myocardial infarction (heart attack)
• if you are a heavy drinker or are taking any other antidepressants or sleeping tablets
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if

• If you have thoughts of harming or killing yourself. These thoughts may be increased when first starting treatment, since BIOTECH TRAZODONE takes time to work, usually about two weeks but sometimes longer. You may be more likely to think like this
• If you have previously had thoughts about killing or harming yourself
• If you are a young adult. There is an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Also tell your doctor:
• If you have heart problems such as coronary artery disease (condition that affects the supply of blood to the heart) and problems with the heart rhythm
• If you suffer from epilepsy (fits or seizures)
• If you have severe kidney or liver problems
• If you have an overactive thyroid gland (hyperthyroidism)
• If you have problems passing water or needing to pass water (urine) more frequently
• If you have narrow angle glaucoma (an eye disease)
• If you have porphyria
• If you have schizophrenia or another type of mental disorder
• If you are elderly, since you may be more prone to side effects, especially when taking other medicines at the same time as BIOTECH TRAZODONE or if you have some other diseases
• If you have high blood pressure, as your doctor may need to reduce the dose of the antihypertensive medicine
• If you are taking opioids and BIOTECH TRAZODONE together – this can cause a dangerous condition called serotonin syndrome, which can be life-threatening
• If you have depression or other conditions that are treated with antidepressants. The use of these medicines together with BIOTECH TRAZODONE can lead to serotonin syndrome, a potentially life- threatening condition. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Children and adolescents BIOTECH TRAZODONE is not recommended for use in children and adolescents under 18 years old. If any of these apply to you, tell your doctor before you take BIOTECH TRAZODONE

Pregnancy and breastfeeding

• Safety in pregnancy and lactation has not been established
• Pregnant women should not use BIOTECH TRAZODONE
• 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 BIOTECH TRAZODONE
• If you take BIOTECH TRAZODONE, you should not breastfeed your baby
• No data available in fertility
• BIOTECH TRAZODONE contains lactose

Interactions and medicines to check

The approved leaflet names these interactions.

• Other antidepressants such as amitriptyline or fluoxetine
• Muscle relaxants and inhaled anaesthetics
• Phenothiazines e.g., chlorpromazine, fluphenazine, levomepromazine, perphenazine (for treating schizophrenia)
• Antihistamines (for e.g., chlorpheniramine)
• Sleeping tablets and tranquilizers
• Barbiturates (used to treat depression)
• Pimozide (for treating uncontrolled movements, tics)
• Alcohol
• Levodopa (used for Parkinson’s disease)
• Anxiolytics. BIOTECH TRAZODONE may increase plasma concentrations of:
• Digoxin
• Carbamazepine, phenytoin (used in treatment of epilepsy)
• MAOI (Mono Amine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks
• If you are taking opioids and BIOTECH TRAZODONE together – this can cause a dangerous condition called serotonin syndrome, which can be life-threatening
• Amiodarone
• Medicines used to treat high blood pressure (e.g., clonidine)
• Medicines used to treat fungal infections such as ketoconazole and itraconazole
• Erythromycin (antibiotic used to treat infections)
• Warfarin (a medicine used to stop blood from clotting)
• Some medicines used to treat HIV such as ritonavir, indinavir and nefazodone
• St. John’s Wort (a herbal medicine)
• Oral contraceptives
• Cimetidine (inhibits stomach acid production)
• Other antipsychotics
• Lithium (to treat major depressive disorder and bipolar disorder) Anaesthetics If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking BIOTECH TRAZODONE. BIOTECH TRAZODONE with food, drink and alcohol BIOTECH TRAZODONE should be taken with food. You should avoid drinking alcohol while taking BIOTECH TRAZODONE
• This is because BIOTECH TRAZODONE can change the way alcohol affects you

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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