Birth control pill Long-Term Side Effects

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Answer side-effect and tolerability questions around birth control pill, including expected changes, warning signs and safe escalation guidance.

What is birth control pill?

Combined and progestogen-only pills 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:

• levonorgestrel — ERMAFT, PHARMACARE LIMITED (Tablets)
• desogestrel — MERCILON, Organon South Africa (Pty) Ltd (Tablets)
• drospirenone — CONTREZ, INNOVATA PHARMACEUTICALS (PTY) LTD (Tablet)
• gestodene — MIRELLE, Bayer (Pty) Ltd (Coated tablet)
• norethisterone — NUR-ISTERATE, Bayer (Pty) Ltd (Solution for injection)

Who should take extra care

Cautions from each medicine’s approved leaflet.

Levonorgestrel (ERMAFT)

Do not use it at all if:

• If you are hypersensitive (allergic) to levonorgestrel or to any other ingredients of ERMAFT
• If you have severe liver problems
• If you are pregnant or suspect that you are pregnant
• If you suffer from bleeding between your regular menstrual cycles (periods) that has not been diagnosed by your doctor, or if you have a history of or current high risk of arterial disease
• If you had already taken ERMAFT within the same monthly cycle
• If you have depression, which is not well controlled with treatment

Use with care, and tell your doctor, if:

• ERMAFT is only intended for occasional use and should not be taken on a regular basis, or as a substitute for long-term birth control. Talk to your doctor or pharmacist about long-term birth control methods
• If you still become pregnant after using ERMAFT, your doctor will closely evaluate you for an ectopic pregnancy especially if you have a history of an ectopic pregnancy, fallopian tube surgery or a pelvic inflammatory disease
• A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy
• If you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of ERMAFT
• The use of ERMAFT does not protect you against sexually transmitted diseases (STDs). If you are worried about a sexual transmitted disease, talk to your doctor or pharmacist. Tell your doctor before using ERMAFT:
• If you are on treatment for depression

Desogestrel (MERCILON)

Do not use it at all if:

• If you have, or have had in the past a blood clot (thrombosis) in a blood vessel of the leg, S3 lung (embolus) or other organs
• If you have or have had a heart attack or stroke in the past
• If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke)
• If you have a disturbance of blood clotting (e.g., protein C deficiency)
• If you need major surgery (e.g., an operation) and your ability to move around is limited for a long period of time
• If you have (had) a type of migraine called “migraine with aura”

Use with care, and tell your doctor, if:

• you smoke
• you have diabetes
• you are overweight
• you have high blood pressure
• you have a heart valve disorder or a certain heart rhythm disorder
• you have inflammation of your veins (superficial phlebitis)

Drospirenone (CONTREZ)

Do not use it at all if:

• are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of CONTREZ (listed in section 6). This may cause itching, rash or swelling
• have (or had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
• know you have a disorder affecting your blood clotting (for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, or antiphospholipid antibodies)
• Have (or had) a blood clot in your arteries (arterial thromboembolism)
• need an operation or if you are off your feet for a long time
• have ever had a heart attack or stroke

Use with care, and tell your doctor, if:

• you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke. For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”
• a close relative has or has ever had breast cancer
• you have a disease of the liver or the gallbladder
• you have diabetes
• you have depression
• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)

Gestodene (MIRELLE)

Do not use it at all if:

• if you are hypersensitive (allergic) to ethinylestradiol, gestodene or any of the other ingredients in MIRELLE. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body
• if you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• if you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack)
• if you have a high risk of venous or arterial blood clots
• if you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness or numbness in any part of your body)

Use with care, and tell your doctor, if:

• if you smoke
• if you have diabetes
• if you are overweight
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder
• if you have an inflammation of your veins (superficial phlebitis)

Norethisterone (NUR-ISTERATE)

Do not use it at all if:

• If you are pregnant or think you might be pregnant
• If you are suffering from or have a history of a thromboembolic disorder in your veins. Thrombosis is the formation of a blood clot. This may occur for example in the blood vessels of the legs (deep vein thrombosis) and the lungs (pulmonary embolism). See also the section “NUR-ISTERATE and thrombosis”
• If you have or have had a severe arterial, including cardiovascular, disease such as heart attack, stroke or ischaemic heart disease (angina pectoris). See also the section “NUR-ISTERATE and thrombosis”
• If you suffer from increased blood pressure requiring treatment
• If you suffer or have suffered from a severe liver disease (as long as your liver function values have not returned to normal). Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body
• If you have or have had a benign or malignant liver tumour

Use with care, and tell your doctor, if:

• you smoke
• you have diabetes
• you are overweight
• you have had venous thromboembolism or anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age)
• anyone in your immediate family has had breast cancer
• you have high blood pressure

Common side effects of birth control pill

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.

Levonorgestrel (ERMAFT)

• Headaches or dizziness
• nausea (feeling sick), vomiting (being sick), lower abdominal pain, diarrhoea
• changes in your menstrual cycle (period), irregular bleeding, vaginal bleeding not related to your menstrual cycle
• breast tenderness
• fever, feeling tired
• Breast enlargement in men
• changes in your libido (sex drive)
• changes in your liver enzyme results when blood tests are done
• pain in your stomach area
• hives (red, raised, itchy skin rash)
• painful menstruation with abdominal cramps, pelvic pain
• swelling of your face. Side effects with an unknown frequency

The leaflet lists 8 more. Read the full leaflet.

Desogestrel (MERCILON)

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• increase or decrease in body weight Uncommon (occurring in more than one per 1000 users but not more than one per 100 users):
• fluid retention
• decreased or increased sexual drive
• migraine
• vomiting, diarrhoea
• rash, hives
• breast enlargement Rare (occurring in less than one per 1000 users):
• hypersensitivity reactions

The leaflet lists 6 more. Read the full leaflet.

Drospirenone (CONTREZ)

• mood swings
• headache
• nausea
• breast pain, problems with your periods, such as irregular periods, absence of period
• vaginal discharge
• depression, nervousness, sleepiness
• dizziness, ‘pins and needles’
• migraine, varicose veins, increased blood pressure
• stomachache, vomiting, indigestion, intestinal gas, inflammation of the stomach, diarrhoea
• acne, itching, rash
• aches and pains, e.g. back pain, limb pain, muscle cramps
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flushes, inflammation of the vagina (vaginitis), problems with your periods, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear, decreased interest in sex

The leaflet lists 26 more. Read the full leaflet.

Gestodene (MIRELLE)

• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness
• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex
• breast enlargement

The leaflet lists 21 more. Read the full leaflet.

Norethisterone (NUR-ISTERATE)

• uterine/vaginal bleeding including spotting (light bleeding from the vagina similar to, but lighter than, a period)
• short lasting absence of monthly bleeding (amenorrhoea)
• increased weight
• dizziness
• headache
• nausea
• skin disorder such as rashes
• injection site reaction
• depressed mood

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with birth control pill makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

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.

What happens after stopping or changing the method?

What happens after stopping or changing birth control pill depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

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.

Related pages

• Triphasil side effects

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