Morphine Side Effects

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

What is morphine?

Morphine contains the active ingredient Morphine sulphate.

• Active ingredient — Morphine sulphate
• Registration holder — FRESENIUS KABI MANUFACTURING SA

It is approved for:

• Morphine Sulphate Fresenius contains the active ingredient morphine sulphate
• Morphine Sulphate Fresenius is used for the relief of severe and persistent pain where non-narcotic pain relief medication is ineffective

Common side effects of morphine

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

• A feeling of light-headedness (which would be due to lowering of blood pressure) especially when standing
• Increased sweating
• Warm sensation of the face
• Drowsiness
• Nausea (feeling sick), vomiting (being sick), constipation
• Unusual tiredness or weakness

Less frequent side effects

• Loss of appetite
• False sense of well-being (unpleasant or uncomfortable mood)
• A feeling of restless
• Decreased in sexual drive, inability to get an erection
• Sleeplessness
• Confusion
• Hallucinations (seeing, feeling or hearing things that are not there)
• Headache
• Dry mouth
• Stomach cramps or pain
• A condition when the bowel does not work properly (paralytic ileus)
• Inflammation of the colon
• Feeling faint when getting up from a seated position
• Biliary spasm (spasms in the lower stomach area)
• Rash
• Muscle rigidity (muscle stiffness)
• Trembling or uncontrolled muscle movements
• Difficulty in urinating
• Pain and irritation at the site of injection
• Abdominal pain, including inflamed and irritated pancreas. Side effects with frequency unknown
• Nightmares or unusual dreams
• Convulsions
• Blurred vision
• Dependence
• Mood changes
• Sensation of whirling and loss of balance (vertigo)
• Increased sensitivity to pain
• Feeling of extreme happiness
• The pupil of your eye becomes smaller
• Ringing or buzzing in the ears (tinnitus)
• Changes in body temperature from feeling cold to sweating
• Sleep apnoea (breathing pauses during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system, e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever

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 morphine sulphate or any of the other ingredients of Morphine Sulphate Fresenius
• if you are taking medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs) (e.g. phenelzine, tranylcypromine, moclobemide or selegiline) or have taken them in the last 10 days
• if you have difficulty in breathing, shortness of breath, suffer from chronic asthma, chronic lung disease and any obstructive airway disease
• if you have excessive bronchial secretion
• if you are an alcoholic
• if you have convulsive disorders (fits and seizures)
• if you have head injuries or increased pressure in the head
• if you suffer from heart problems
• if you have severe stomach cramps caused by a condition known as biliary colic
• if you are at risk of having a blocked intestine (paralytic ileus)
• if you are suffering from a tumour of the adrenal gland known as a phaeochromocytoma
• if you suffer from severe diarrhoea
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if

• Hypothyroidism – underactive thyroid gland
• Adrenocortical insufficiency – undersupply of corticosteroid hormones by the body
• Impaired kidney or liver function
• Enlarged prostate
• Convulsions (fits and seizures)
• Shock (the symptoms of which include sweating, a fast pulse and cold, clammy skin)
• Inflammatory or obstructive bowel disorders
• Myasthenia gravis – weakness of selected muscles
• Lung and/or breathing disorders
• Hypotension – low blood pressure (the symptoms of which include dizziness or light- headedness)
• Biliary tract disease
• If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
• Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production
• Abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the interval between doses. Take special care with Morphine Sulphate Fresenius
• Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphine Sulphate Fresenius treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Morphine Sulphate Fresenius or other opioids. Stop using Morphine Sulphate Fresenius and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever
• Sleep-related breathing disorders: Morphine Sulphate Fresenius can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor
• Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system. Tolerance, dependence, and addiction Morphine Sulphate Fresenius contains morphine which is an opioid medicine. Repeated use of opioids can result in the medicine being less effective (you become accustomed to it, known as tolerance). Repeated use of Morphine Sulphate Fresenius can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Morphine Sulphate Fresenius if:
• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• You are a smoker
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs whilst taking Morphine Sulphate Fresenius, it could be a sign that you have become dependent or addicted:
• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’) If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely

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 receiving Morphine Sulphate Fresenius

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to treat depression, e.g. antidepressants
• Consuming alcohol
• Medicines use to help you sleep, e.g. sleeping tablets
• Medicines used to treat anxiety, tension, seizures, panic or sleep disorders, e.g. sedatives
• Medicines used to control heart rhythm or rate, e.g. mexiletine
• Medicines used to treat bacterial infections, e.g. ciprofloxacin
• Medicines used to treat psychiatric or mental disorders (such as phenothiazines)
• Medicines used to treat diarrhoea, e.g. loperamide, kaolin
• Medicines used as premedication before operations and after heart attacks, e.g. atropine
• Medicines used to treat nausea and vomiting, e.g. metoclopramide, domperidone
• Medicines used to treat blood clots, e.g. clopidogrel, prasugrel, ticagrelor
• Medicines used to treat tuberculosis, e.g. rifampicin
• Concomitant use of Morphine Sulphate Fresenius and sedative medicines such as benzodiazepines or related medicines, 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 does prescribe Morphine Sulphate Fresenius together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. A large number of medicines can interact with Morphine Sulphate Fresenius which can significantly alter their effects. These medicines include:
• Gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain) Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Morphine Sulphate Fresenius with alcohol You should not drink alcohol whilst being given Morphine Sulphate Fresenius, as it will increase its effect

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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