Chemotherapy Side Effects

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

Part of cancer treatment side effects.

What is chemotherapy?

Chemotherapy medicines covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• cyclophosphamide — CYCLOCORD 500 mg & 1g, Accord Healthcare (Pty) Ltd (Powder for solution for injection/infusion)
• doxorubicin — DOXOPEG, KEY ONCOLOGICS (PTY) LTD (Liposomal infusion.)
• cisplatin — CISACOR, Accord Healthcare (Pty) Ltd (Solution for infusion.)
• carboplatin — SPALCARB 50/150/450, Ruby Pharmaceuticals (Pty) Ltd (CONCENTRATE FOR SOLUTION FOR INFUSION)
• methotrexate — Methotrexate 500 mg/20 mL Fresenius, Methotrexate 50 mg/2 mL Fresenius, Fresenius Kabi South Africa (Pty) Limited (Injection)
• paclitaxel — Loxat, Oethmaan Biosims (Pty) Ltd (Concentrate solution for infusion)
• docetaxel — TAXOCAN 20 / 80, Zydus Healthcare SA (Pty) Ltd (Solution for infusion)

Common side effects of chemotherapy

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Cyclophosphamide (CYCLOCORD 500 mg & 1g)

• Loss of hair (alopecia)
• Burning sensations or pains during urination and frequent need to urinate (bladder infection)
• Appearance of blood in the urine
• Fever
• Suppression of the immune system
• Infections
• Inflammation of mucous membranes
• Abnormal liver function
• Infertility in men
• Chills
• Feeling of weakness
• Generally feeling unwell

The leaflet lists 98 more. Read the full leaflet.

Doxorubicin (DOXOPEG)

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• yellowing of your skin and eyes, also called jaundice
• These are all very serious side effects. If you have them, you may have had a serious reaction to DOXOPEG. 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: Side effects that occur frequently:
• you develop fever, feel tired, or if you have signs of bruising or bleeding
• redness, swelling, peeling or tenderness, mainly on the hands or feet (‘hand- foot’ syndrome). These effects have been seen very commonly and are sometimes severe. In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely. The doctor may wish to delay the start and/or reduce the dose of the next treatment
• sores in mouth, severe diarrhoea or vomiting or nausea
• infections, including lung infections (pneumonia) or infections that may affect your vision
• being short of breath
• severe stomach pain
• severe weakness/ fainting. Side effects that occur less frequently:

The leaflet lists 64 more. Read the full leaflet.

Cisplatin (CISACOR)

• low sodium levels (you may experience headache, nausea, vomiting, confusion and fatigue)
• changes to your heart rhythm
• nausea and vomiting
• ringing in the ears or changes in your hearing
• loss of appetite, hiccups
• sores in the mouth
• seizures (fits)
• slurred speech
• loss of taste
• memory loss
• Lhermitte’s sign (an electrical sensation that runs down the back and into the legs)
• temporary loss or changes in your eyesight

The leaflet lists 9 more. Read the full leaflet.

Carboplatin (SPALCARB 50/150/450)

• tiredness, shortness of breath and paleness caused by anaemia (a condition in which there is a decreased number of red blood cells)
• feeling sick (nausea) or being sick (vomiting)
• stomach pain and cramp
• signs of infection such as fever or sore throat
• flu-like symptoms
• symptoms of severe allergic reaction include sudden wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, low blood pressure, rapid heart beat, hives, shortness of breath, dizziness and anaphylactic shock
• tingling or numbness in your hands, feet, arms or legs
• burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• temporary worsening of eyesight or changes to your vision
• ringing in the ears or changes in your hearing

The leaflet lists 29 more. Read the full leaflet.

Methotrexate (Methotrexate 500 mg/20 mL Fresenius, Methotrexate 50 mg/2 mL Fresenius)

• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• inflammation of the lung with breathlessness – you may develop a persistent cough, experience pain or difficulty breathing, or become breathless. This may be associated with changes in a particular type of white cell in your blood
• symptoms of an infection e.g. fever, chills, achiness, sore throat
• unexpected bleeding e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue
• skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus (back passage)
• diarrhoea
• stroke/ weakness on one side of the body
• abdominal pain, fatty stools, vomiting
• chest pain (which may be due to heart or lung problems)
• unconsciousness Taking Methotrexate Fresenius incorrectly can result in severe side effects and even death

The leaflet lists 40 more. Read the full leaflet.

Paclitaxel (Loxat)

• Infection – usually of the urinary tract or upper respiratory tract. This may be associated with low blood cell count resulting from receiving paclitaxel. This can sometimes be fatal
• Decreased production of blood cells and platelets (myelosuppression), low haemoglobin level (anaemia), low white blood cells, low platelet count, bleeding
• Mild allergic reactions (mainly flushing and rash)
• Nerve problems – these may appear as pins and needles in the hands and feet (can persist beyond 6 months of paclitaxel discontinuation)
• Abnormal ECG, slow heart rate
• Low blood pressure
• Nausea, vomiting, diarrhoea, sores in the mouth or lips
• Hair loss, temporary mild changes to the nails and skin
• Pain in the muscle or joints
• Injection site reactions (local swelling, pain, redness, hardening of tissues, death of skin tissue, extravasation (leaking of drug outside the vein) resulting in cellulitis (painful swelling and redness)
• Changes in blood tests that show how your liver is working
• Shock due to infections (known as ‘septic shock’), pneumonia, peritonitis, blood poisoning (sepsis)

The leaflet lists 28 more. Read the full leaflet.

Docetaxel (TAXOCAN 20 / 80)

• Infections (may include any infection of the lungs, skin, nails, ear, eye, stomach, bladder and vagina, thrush in the mouth)
• Feeling depressed or anxious
• Sleeplessness or tiredness
• Bleeding and bruising easily
• Nose bleeding
• Sensations of tingling, prickling, burning, or numbness
• Seizures or fits
• Fluid retention resulting in swelling
• Nail discolouration
• Poor nail formation. Over time your nail may break away from the nail bed, until it detaches completely
• Dry skin, lips, mouth or throat
• Changing of skin colour

The leaflet lists 28 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

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

Cautions from each medicine’s approved leaflet.

Cyclophosphamide (CYCLOCORD 500 mg & 1g)

Do not use it at all if:

• if you are allergic to cyclophosphamide or to any of the other ingredients listed in section 6.1
• if you currently have any infection
• if you have severe bone marrow disorder (in particular after chemotherapy or radiation therapy). You will have blood tests to check how well your bone marrow is working Initials:
• if you have urinary tract infection, which can be recognised as pain when passing urine (cystitis)
• if you have ever had kidney or bladder problems as a result of previous chemotherapy or radiotherapy
• if you have a condition which decreases your ability to urinate (urinary outflow obstruction)

Use with care, and tell your doctor, if:

• low blood cell counts
• severe infections
• liver or kidney problems. Your doctor will check how well your liver and kidneys are working by doing a blood test
• had your adrenal glands removed
• or already having, or have recently had, radiotherapy or chemotherapy
• heart problems or have had radiotherapy in the area of your heart

Doxorubicin (DOXOPEG)

Do not use it at all if:

• If you are allergic to doxorubicin hydrochloride or any of the other ingredients of DOXOPEG
• If you are pregnant or breastfeeding
• If you have a condition called AIDS-related Kaposi’s sarcoma that may be treated effectively with other treatment, such as local therapy or systemic alpha-interferon
• If you or your child is under the age of 18 years

Use with care, and tell your doctor, if:

• If you have or develop a bone marrow disorder or mouth ulcers after treatment with DOXOPEG. Your doctor will perform blood counts if this occurs
• If you have a liver disorder. You doctor will draw blood prior to the treatment to test your liver function
• If you have a heart disorder, as DOXOPEG may worsen your condition
• If you develop any heart problems during your treatment with DOXOPEG. Your doctor will do regular tests to monitor your heart function. You are at higher risk of developing heart problems if you are elderly, a child or if you have Down’s syndrome
• If you develop blood clots in your veins or your lungs while you receive DOXOPEG (pain in the area affected, swelling of your ankles or feet, difficult or rapid breathing, or pain when you breathe)
• If you are taking other anti-cancer medicines

Cisplatin (CISACOR)

Do not use it at all if:

• you are hypersensitive (allergic) to cisplatin, any other platinum containing product or any ingredient contained in Cisacor
• you have kidney or hearing impairment
• you have problems with your bone marrow (i.e decreased blood cells)
• you are pregnant or breast-feeding
• you have recently received a live vaccination

Use with care, and tell your doctor, if:

• Your doctor should monitor your blood counts
• Your doctor should perform nerve testings before and during Cisacor treatment
• Inform your doctor immediately if you experience pins and needles in your hands and legs, swelling of the eye, blindness and seizures (fits)
• Your doctor should conduct blood tests to detect any kidney damage before each treatment with Cisacor
• Your doctor should also perform hearing tests before each treatment with Cisacor
• If you are of child bearing age, or able to conceive a child, you should use non-hormonal birth control (e.g barrier contraception) during treatment with Cisacor

Carboplatin (SPALCARB 50/150/450)

Do not use it at all if:

• if you are allergic to carboplatin or to any of the ingredients of this medicine (listed in section 6)
• if you have had hypersensitivity to similar platinum containing medicines in the past
• if you have severe kidney disease
• if you have fewer blood cells than normal (your doctor will check this with a blood test)
• if you have a tumour that bleeds
• if you are pregnant and breast feeding

Use with care, and tell your doctor, if:

• if you have mild renal disease. Your doctor will want to monitor you more regularly
• if you are elderly (over 65 years old)
• if you have been treated with cisplatin or similar anti-cancer medicines in the past, carboplatin may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor may regularly assess you
• if you have headache, altered mental functioning, seizures and abnormal vision (from blurriness to vision loss)
• if you develop extreme tiredness and shortness of breath with decreased number of red blood cells, (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome)
• if you have fever (temperature greater than or equal to 38oC), or chills, which could be signs of infection. You may be at risk of getting an infection of the blood. During treatment with SPALCARB you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells that release their content to the bloodstream. Children Safety and efficacy have not been established

Methotrexate (Methotrexate 500 mg/20 mL Fresenius, Methotrexate 50 mg/2 mL Fresenius)

Do not use it at all if:

• if you are allergic (hypersensitive) to Methotrexate or any of the other ingredients of Methotrexate Fresenius
• if you have significant kidney or liver problems
• if you consume excessive amounts of alcohol
• if you have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anaemia) or platelets
• if your immune system is not working as well as it should
• if you are pregnant or breastfeeding. Safety and efficacy in children have not been established other than in cancer chemotherapy

Use with care, and tell your doctor, if:

• if you have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut)
• if you have an infection
• if you have liver or kidney problems (you should be closely monitored by your doctor for any liver or kidney problems)
• if you have a medical condition which causes a buildup of fluid in the lining of your lungs or in your abdomen (the fluid will need to be drained before methotrexate treatment is started)
• if you have abnormal red, white blood cell levels, or platelet levels
• if you are to have radiotherapy (risk of tissue and bone damage may be increased)

Paclitaxel (Loxat)

Do not use it at all if:

• If you are allergic (hypersensitive) to paclitaxel or any of the other ingredients (especially polyoxyl 35 castor oil) of LOXAT listed in section 6
• If your white blood cell counts are abnormal (this is checked by blood tests)
• If you are pregnant or breastfeeding a baby
• If you a child

Use with care, and tell your doctor, if:

• you have, or have previously had liver disease, heart disease or vascular disease
• you have recently had, or are going to have radiotherapy or chemotherapy
• you had and infection or have been vaccinated recently
• you have decreased blood cells and bone marrow function. If you develop a fever, bleeding or think you may be suffering from an infection, please inform your doctor immediately
• you experience chills, fever, rapid heart rate, difficulty breathing, low blood pressure while receiving LOXAT. You may be having a severe allergic reaction to LOXAT
• you experience high or low blood pressure or changes in your heart rate

Docetaxel (TAXOCAN 20 / 80)

Do not use it at all if:

• If you are allergic (hypersensitive) to docetaxel, polysorbate 80 or any of the other ingredients of TAXOCAN (listed in section 6)
• If your doctor has confirmed that your baseline neutrophil count (your white blood cell counts) is lower than 1 500 cells/mm³
• If you are pregnant or breastfeeding. TAXOCAN is harmful to the fetus. Consult your doctor immediately if you become pregnant while receiving treatment with TAXOCAN
• If you are a child. The safety of TAXOCAN in children has not been established
• If you have a serious liver disorder

Use with care, and tell your doctor, if:

• It is very important that your doctor check your progress during regular visits to make sure that your treatment with TAXOCAN is working as it should and to check for unwanted effects. Your doctor will monitor certain stomach reactions (stomach pain, tenderness, fever and diarrhoea), your heart function and your bone marrow
• Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhoea, rectal haemorrhage, blood in your stools or fever. These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal. Your doctor should address them immediately
• TAXOCAN may cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis or acute generalised exanthematous pustulosis. Please If you develop severe skin reactions, immediately contact your doctor
• If you suffer from pain in your side, or reduced amount or darkening of urine after TAXOCAN infusion, tell your doctor immediately
• TAXOCAN can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. Before each treatment with TAXOCAN some blood tests need to be done to check that you have enough blood cells and good liver function before receiving TAXOCAN
• Your doctor may give you other medicines to maintain the number of your blood cells

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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