Provera Side Effects

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

What is Provera?

Provera contains the active ingredient Medroxyprogesterone acetate.

• Active ingredient — Medroxyprogesterone acetate
• Registration number — S/21.8.2/1; W/21.8.2/462
• Registration holder — Pfizer Laboratories (Pty) Ltd

It is approved for:

• PROVERA is used in the treatment of cancer of the lining of the womb, cancer of the kidney(s)
• Breast cancer in postmenopausal women

Common side effects of Provera

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 swallowing or breathing
• Rash or itching
• Yellowing of the skin and eyes, also called jaundice
• Cerebral infarction (stroke resulting from a blockage in the blood vessels supplying blood to the brain)
• Heart failure, heart attack
• Blood clots in the veins
• Blood clots in the lungs These are all very serious side effects
• If you have them, you may have had a serious reaction to PROVERA. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following: Frequently side effects
• Change in weight
• Increased appetite
• Difficulty sleeping
• Headache
• Dizziness
• Tremors
• Vomiting
• Constipation
• Feeling sick (nausea)
• Increased sweating
• Inability to maintain an erection
• Swelling of feet and ankles
• Fluid retention
• Extreme tiredness Less frequent side effects
• Medicine sensitivity
• Corticosteroid-like effects
• Worsening of diabetes
• Increased calcium levels in the blood
• Depression
• Intense feeling of happiness or excitement
• Change in sex drive
• Nervousness
• Drowsiness/sleepiness
• Inflammation of the veins
• Diarrhoea
• Dry mouth
• Acne
• Excessive hair growth
• Hair loss
• Rash
• Muscle spasms
• Irregular and/or increased/decreased menstrual bleeding, spotting
• Breast pain
• Feeling unwell
• Fever
• Decreased glucose tolerance
• Increased blood pressure Frequency not known
• Noncancerous tumour of the tissue surrounding the brain and spinal cord
• Delayed ovulation
• Confusion
• Loss of concentration
• Increased heart and/or breathing rate and/or increased sweating
• Blood clot in the eye, blurry vision, impaired vision
• Fast, irregular heartbeat, palpitations
• Itchiness, red/itchy bumps on skin
• Increased glucose levels in urine
• Absence of menstrual period
• Changes to the cervix
• Cervical discharge
• Milk flow from the breasts not as a result of pregnancy or breastfeeding
• Abnormal liver function test
• Increased white blood cell count
• Increased red blood cell count Other side effects reported during post marketing
• Rounded appearance of the face
• Severe depression with a higher risk of suicidal thoughts/behaviour and suicide
• Loss of fat tissue
• Breast tenderness

Serious side effects and warning signs

The leaflet lists these as serious side effects needing immediate attention.

Less frequent

• Medicine sensitivity
• Corticosteroid-like effects
• Worsening of diabetes
• Increased calcium levels in the blood
• Depression
• Intense feeling of happiness or excitement
• Change in sex drive
• Nervousness
• Drowsiness/sleepiness
• Inflammation of the veins
• Diarrhoea
• Dry mouth
• Acne
• Excessive hair growth
• Hair loss
• Rash
• Muscle spasms
• Irregular and/or increased/decreased menstrual bleeding, spotting
• Breast pain
• Feeling unwell
• Fever
• Decreased glucose tolerance
• Increased blood pressure

Frequency not known

• Noncancerous tumour of the tissue surrounding the brain and spinal cord
• Delayed ovulation
• Confusion
• Loss of concentration
• Increased heart and/or breathing rate and/or increased sweating
• Blood clot in the eye, blurry vision, impaired vision
• Fast, irregular heartbeat, palpitations
• Itchiness, red/itchy bumps on skin
• Increased glucose levels in urine
• Absence of menstrual period
• Changes to the cervix
• Cervical discharge
• Milk flow from the breasts not as a result of pregnancy or breastfeeding
• Abnormal liver function test
• Increased white blood cell count
• Increased red blood cell count

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 medroxyprogesterone acetate or to any of the other ingredients in PROVERA (listed in section 6)
• if you are, or think you may be pregnant
• if you have unexplained vaginal bleeding
• if you have liver problems

Use with care, and tell your doctor, if

• if you experience unexpected vaginal bleeding, please contact your doctor who will investigate further
• if you have a condition that may be affected by weight gain or fluid retention as PROVERA may cause these conditions to worsen
• if you have suffered from depression, please tell your doctor and stop treatment if it reoccurs
• if you suffer from diabetes as PROVERA may decrease your glucose tolerance
• if there is a sudden partial or complete loss of vision, double vision or migraine you should stop taking PROVERA
• if you develop inflammation of the veins or blood clots in the veins, PROVERA treatment should be stopped
• if you suffer from a decreased bone mineral density, long-term use of PROVERA may worsen this
• if you are using a combined oral hormonal treatment post menopause (menopausal hormone therapy (MHT) with PROVERA, this may increase your risk of getting certain cancers like breast cancer and cancer of the ovaries
• if you have a history of stroke, heart attack, heart disease or a blood clot in the lungs
• if you are diagnosed or had a history of meningioma (a usually benign tumour that forms in the layers of tissue that cover your brain and spinal cord)
• if you suffer from dementia
• if you have or have had breast cancer (unless you have been prescribed PROVERA for breast cancer) Meningioma Use of PROVERA has been linked to the development of a usually benign tumour of the tissue surrounding the brain and spinal cord (meningioma). The risk increases especially when you use it for longer duration (several years). If you are diagnosed with meningioma, your doctor will reconsider your treatment with PROVERA Tablets. If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your health care provider straightaway. PROVERA may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression, contact your doctor for advice. Before starting treatment, you should undergo a complete medical and family history examination. During treatment, periodic examinations should include blood pressure, breasts, abdomen, pelvic organs and a pap smear. The results of some laboratory tests can be affected if you are taking PROVERA it is important to tell the health care provider you are taking PROVERA if tests and/or samples are being taken

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 PROVERA
• PROVERA is not to be used in women who are pregnant
• You should not take PROVERA if you are breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine
• (This includes complementary or traditional medicines.) Tell your doctor or health care provider if you are taking a medicine called aminoglutethimide (medicine use to treat breast and prostate cancer) as this may affect the way PROVERA works

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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