Amitriptyline Side Effects

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

What is amitriptyline?

Amitriptyline contains the active ingredient Amitriptyline hydrochloride.

• Active ingredient — Amitriptyline hydrochloride
• Registration number — J/1.2/219; J/1.2/220
• Registration holder — PHARMACARE LIMITED

It is approved for:

• TREPILINE contains amitriptyline
• Amitriptyline belongs to a group of medicines called tricyclic antidepressants
• These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression
• TREPILINE is used to treat the symptoms of depression in patients 18 years and older

Common side effects of amitriptyline

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.

Reported side effects

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TREPILINE. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• Heart attack (symptoms may include pain or pressure in the chest, discomfort spreading to the back, jaw, throat or arm, nausea, indigestion or heartburn, weakness, anxiety or shortness of breath and rapid or irregular heartbeats)
• Stroke (symptoms may include sudden numbness or weakness of the face, arm or leg, especially on one side of the body, sudden confusion, trouble speaking or understanding speech, sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination and sudden severe headache with no known cause)
• Yellowing of the skin and eyes, also known as jaundice
• Feeling faint when getting up (postural hypotension), increased blood pressure, fast/racing heart, palpitations, irregular or slow heart beats and very low blood pressure
• Bone marrow depression or reduction in some blood cells (you may experience mouth ulcers and recurring infections, bleeding or bruising easily)
• Difficulty passing water (urine)
• Coma (state of unconsciousness)
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: The following side effects have been frequently reported:
• Drowsiness, sleepiness
• Blurred vision, accommodation disturbance (difficulty to focus when looking at an object), increased pressure within the eye ball
• Dry mouth, constipation
• Hyperthermia (body temperature above the normal value). The following side effects have been reported less frequently:
• Urticaria (skin rash characterised by pale red itchy bumps), photosensitisation (reaction of skin to sunlight)
• Inappropriate secretion of ADH (antidiuretic hormone) which may make you urinate more frequently, changes in blood sugar levels, changes blood sodium levels
• Increased appetite, weight gain, weight loss, anorexia (loss of appetite)
• Confusion, disorientation (not knowing where you are), agitation (state of anxiety), insomnia (difficulty sleeping), nightmares, anxiety (feeling of worry), restlessness, disturbed concentration, dysarthria (condition where the muscles used for speech is weak), change in behaviour, suicidal thoughts or behaviour
• Dizziness, headache, peripheral neuropathy (weakness, numbness or pain in hands and feet), pins and needles, lack of coordination, ataxia (loss of full control of body movements), tremors, fits, tardive dyskinesia (involuntary movements of the face and jaw)
• Mydriasis (enlargement of the pupil of the eyes)
• Tinnitus (ringing in the ears)
• Nausea (feeling sick), vomiting (being sick), diarrhoea, paralysis of the intestine, epigastric distress (characterised by slow bowel movements), inflammation in the mouth, dysgeusia (distortion of taste), swelling of the parotid gland (which produces saliva or spit), black tongue
• Hepatitis (inflammation of the liver)
• Skin rash, alopecia (temporary hair loss)
• Increased passing of urine, urinary tract dilation (can be caused by infection)
• Breast swelling in men and women, galactorrhoea (milky nipple discharge unrelated to the normal milk production of breastfeeding), swelling of testicles, disturbances in sexual function or sex drive
• Weakness, feeling tired, increased sweating. The following side effects have been reported with an unknown frequency:
• Increased risk of bone fractures

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 allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or to any inactive ingredients
• If you have recently had a heart attack
• If you are taking monoamine oxidase inhibitors (MAOIs) or you have taken MAOIs within the previous 14 days for the treatment of depression
• If you are taking certain medicines for the treatment of high blood pressure
• If you are pregnant or breastfeeding
• If the child is under 18 years of age
• If you have heart disease such as irregular heart beats, heart block or failure, coronary artery disease
• If you suffer from periods of increased and exaggerated behaviour (mania)
• If you have severe liver disease
• If you are taking linezolid (which is an antibiotic)

Use with care, and tell your doctor, if

• TREPILINE should at all times be kept out of sight and reach of children, as even small doses may be fatal to them
• TREPILINE may cause drowsiness at the start of therapy
• If you experience dry mouth, constipation, difficulty to urinate and blurred vision or other vision disturbances, consult your doctor
• If you have drowsiness, agitation, restlessness or insomnia (inability to sleep)
• If you have hypertension (high blood pressure) or a heart disorder
• If you have changes in libido (sex drive), interference with sexual function, gynecomastia (enlargement of man’s breasts), breast enlargement in women, galactorrhoea (flow of milk from breast not whilst breastfeeding)
• If you have diabetes (high blood sugar levels)
• If you have a psychiatric disorder (such as mania or depression)
• If you have thoughts of harming or killing yourself
• If you are due to have any surgery that involves an anaesthetic
• If you are taking medicines called epinephrine or norepinephrine, TREPILINE can increase these medicines’ effects
• If you have a condition called porphyria
• If you have a thyroid gland disorder
• If you have a liver disorder
• If you suffer from epilepsy (seizures or fits)
• If you have an eye condition called glaucoma (increased pressure in the eye)
• If you are not able to pass water (urinate) or have an enlarged prostate gland
• If you have constipation
• If you develop allergic skin reactions
• If you are taking medicines called barbiturates or alcohol- their effects can be increased
• If you are being given electroconvulsive therapy (ECT) (procedure when electric currents are passed through the brain)
• If you develop low levels of sodium in your blood that can arise as the following symptoms: if you feel drowsy, confused or have fits
• If you are an elderly person (older than 65 years of age)

Pregnancy and breastfeeding

• You should not take TREPILINE if you are pregnant or breastfeeding your baby
• If you are pregnant or breastfeeding, please consult your doctor, pharmacist or other healthcare professional for advice before taking TREPILINE
• Driving and using machinery Since adverse reactions such as drowsiness, dizziness and blurred vision have been reported in patients taking TREPILINE, you should not drive, use machinery or perform any tasks that require concentration, until you are certain that TREPILINE does not adversely affect your ability to do so
• Important information about some of the ingredients of TREPILINE TREPILINE contain lactose monohydrate, which is a type of sugar
• If you have been told by your doctor that you cannot tolerate or digest some sugars (you have an intolerance to some sugars), talk to your doctor before taking TREPILINE

Interactions and medicines to check

The approved leaflet names these interactions.

• Monoamine oxidase inhibitors: medicines used to treat depression such as selegiline
• Medicines used to treat depression (serotonin reuptake inhibitors such as fluoxetine, norepinephrine reuptake inhibitors such as reboxetine)
• Apraclonidine and brimonidine: medicines used to treat an eye disorder called glaucoma
• Tramadol: medicine used to treat moderate to severe pain
• Anaesthetics: medicines used to in surgery to reduce your sensitivity to pain
• Amiodarone, disopyramide, procainamide, propafenone, quinidine, sotalol, isoprenaline: medicines used to treat heart disorders
• Rifampicin: medicine used to treat tuberculosis
• Linezolid: medicine used to treat certain types of bacterial infections
• Calcium-channel blockers (diltiazem and verapamil), guanethidine, dibrisoquine, bethanidine or clonidine: medicines used to treat high blood pressure
• Sympathomimetic medicines such as adrenaline (epinephrine), ephedrine, isoprenaline, noradrenaline (norepinephrine), phenylephrine and phenylpropanolamine: these may be present in many cough and cold remedies
• Methylphenidate: medicine used to treat attention-deficit disorder
• Barbiturates: medicines that cause central nervous system depression, including medicines used to treat anxiety or sleeping disorders
• Carbamazepine: medicines used to treat epilepsy
• Disulfiram: medicine used to treat alcohol abuse, as part of a treatment plan
• Fluconazole: medicine used to treat fungal infections
• Antihistamines: medicines used to treat allergies
• Ritonavir: medicine used to treat HIV infection
• Pimozide and thioridazine: medicines used to treat psychiatric disorders
• Diuretics (water tablets): medicine used to treat high blood pressure
• Entacapone: medicine used to treat Parkinson’s disease
• Baclofen: medicine used to treat muscle cramps
• Nitrates: medicine used to treat angina
• Oral contraceptives: medicines used to prevent pregnancies
• Anticholinergic medicines (e.g. atropine): medicines that block a neurotransmitter called acetylcholine
• Cimetidine: medicine used to treat heartburn or stomach ulcers
• St. John’s Wort: herbal medicine used to treat depression
• Thyroid hormones: medicines used to treat a thyroid gland disorder

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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