Tramadol Side Effects

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

What is tramadol?

Tramadol contains the active ingredient Tramadol hydrochloride.

• Active ingredient — Tramadol hydrochloride
• Registration number — 50/2.9/0401
• Registration holder — Unimed Healthcare (Pty) Ltd

It is approved for:

• Tramadol hydrochloride is the active ingredient in TRAMADOL UNIMED
• It is a painkiller belonging to the class of opioids that acts on the central nervous system
• It relieves pain by acting on specific nerve cells of the spinal cord and brain
• TRAMADOL UNIMED is used for the treatment of moderate to severe pain

Common side effects of tramadol

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

• headaches, drowsiness
• fatigue
• constipation, dry mouth, being sick (vomiting)
• sweating (hyperhidrosis)

Less frequent side effects

• effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain
• urge to sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea
• abdominal pain, inflammation of the pancreas (pancreatitis)
• skin reactions (e.g. itching, rash)
• allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
• Epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits
• hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
• psychological complaints may appear after treatment with TRAMADOL UNIMED. Their intensity and nature may vary (according to the patient’s personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement )
• drug dependence may occur. When treatment is stopped abruptly, signs of withdrawal may appear
• blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis)
• If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down (respiratory depression)
• weak muscles
• passing urine with difficulty or pain, passing less urine than normal (dysuria)
• hepatic enzyme increased
• decrease in blood sugar level

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 tramadol or any of the other ingredients of TRAMADOL UNIMED (listed in section 6)
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with TRAMADOL UNIMED
• if you are an epileptic
• as a substitute in narcotic withdrawal
• if you have difficulty in breathing
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease)
• if you are pregnant or breastfeeding
• if you or your child are younger than 18 years of age and you or your child have had an operation to remove your tonsils or adenoids
• if you or your child are younger than 12 years of age

Use with care, and tell your doctor, if

• if you think that you are addicted to other pain relievers (opioids) because TRAMADOL UNIMED may lead to physical and psychological addiction. When TRAMADOL UNIMED is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development). Please also inform your doctor if one of these problems occurs during TRAMADOL UNIMED treatment or if they applied to you in the past
• if you are sensitive to addictive substances (opiates)
• if you are taking other centrally depressant medicines. Respiratory depression (slow and ineffective breathing) may develop if TRAMADOL UNIMED are given concomitantly with other centrally depressant medicines
• if you are in a state of shock (cold sweat may be a sign of this)
• if you suffer from a liver or kidney disease, as the elimination of TRAMADOL UNIMED is delayed Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking TRAMADOL UNIMED and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite
• if you have a history of mental health disorders (difficulty in thinking, understanding and judging clearly which causes loss of touch with reality), if you have depression, anxiety and suffer from alcohol or drug abuse. Sleep-related breathing disorders TRAMADOL UNIMED contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnoea (shallow/pause of breathing during sleep) and sleep- related hypoxemia (low level of oxygen in the blood). The risk of experiencing central sleep apnoea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnoea. Epilepsy or seizures Tell your doctor if you are suffering from epilepsy or are susceptible to seizures as TRAMADOL UNIMED is not recommended in the presence of these conditions. Children TRAMADOL UNIMED capsules are not suitable for children younger than 12 years of age. Other medicine and TRAMADOL UNIMED Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
• TRAMADOL UNIMED should not be taken together with MAO inhibitors (certain medicines for the treatment of depression)
• The pain-relieving effect of TRAMADOL UNIMED may be reduced and the length of time it acts may be shortened, if you take medicines which contain carbamazepine (for epileptic fits)
• TRAMADOL UNIMED might decrease the anti-nausea effect of ondansetron and increase the requirement for TRAMADOL UNIMED in patients with postoperative pain. if you are taking other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking TRAMADOL UNIMED. you may feel drowsier or feel that you might faint. Concomitant use of TRAMADOL UNIMED and tranquillizers or sleeping pills (e.g. benzodiazepines), increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes TRAMADOL UNIMED together with sedating medicines the dose and the duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating medicines you are taking and follow your doctor’s dose recommendation closely
• if you are taking medicines which may cause convulsions (fits), such as certain tricyclic antidepressants, antipsychotics or other threshold lowering medicine. The risk having a fit may increase if you take TRAMADOL UNIMED at the same time
• if you are taking certain medicine that stimulate serotonin (chemical that contributes to happiness) receptors, TRAMADOL UNIMED may interact with these medicines and it may cause serotonin toxicity with symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 °C. Withdrawal of the serotonergic medicines usually brings about a rapid improvement
• if you are taking coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with TRAMADOL UNIMED. The effect of these medicines on blood clotting may be affected and bleeding may occur
• interactions are unlikely to occur with concomitant or previous administration of cimetidine (antacid)
• if you suffer from a liver disease. Ketoconazole (anti-fungal) and erythromycin (antibiotic) inhibit the liver enzymes CYP3A4. TRAMADOL UNIMED with food and alcohol Do not drink alcohol during treatment with TRAMADOL UNIMED as its effect may be intensified. Food does not influence the effect of TRAMADOL UNIMED

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 health care provider for advice before taking TRAMADOL UNIMED
• There is very little information regarding the safety of tramadol in human pregnancy
• Therefore, you should not use TRAMADOL UNIMED if you are pregnant
• The child may experience withdrawal symptoms after birth
• Tramadol is excreted into breast milk
• For this reason, you should not take TRAMADOL UNIMED during breast-feeding, or alternatively, if you take TRAMADOL UNIMED, you should stop breast- feeding

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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