Tadalafil Side Effects

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

What is tadalafil?

Tadalafil contains the active ingredient Tadalafil.

• Active ingredient — Tadalafil
• Registration number — A49/7.1.5/0285; A49/7.1.5/0286
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• TADALAFIL DYNA contains the active substance tadalafil
• TADALAFIL DYNA is a treatment for men with erectile disfunction
• This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity
• Tadalafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors

Common side effects of tadalafil

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

• headache
• reddening of the face (flushing)
• stuffy nose
• discomfort in your stomach
• back pain, pain in your muscle or any part of your body

Less frequent side effects

• dizziness
• loss of consciousness or numbness on one side of the body
• fainting, severe headache (migraine), sudden memory loss
• blurred vision or loss of vision, eye pain, swelling of eyelids, redness or itching of the eye
• ringing in the ears, loss of hearing
• changes in heart rhythm, chest pain or feeling of pressure in chest
• low or high blood pressure
• difficulty breathing, nose bleeds
• stomach pain, nausea, vomiting, heartburn or burning sensation in your throat
• rash, sweating
• blood in urine
• prolonged erections, blood in the sperm or bleeding from the penis
• chest pain, tiredness, swelling of the legs or face
• sudden cardiac death

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 tadalafil or any of the other ingredients of TADALAFIL DYNA
• if you are taking any form of a group of medicines called nitrates
• These are used in the treatment of angina
• if you have serious heart disease or recently had a heart attack within the last 90 days
• if you have chest pains during or after sexual activity, have abnormal heart rhythm or heart failure
• if you recently had a stroke within the last 6 months
• if you have low blood pressure or uncontrolled high blood pressure
• if you have severe hepatic (liver) insufficiency (Child-Pugh Class C)
• if you have ever had loss of vision because of a condition called non-arteritic anterior ischemic optic neuropathy (NAION), also described as “stroke of the eye”. This may or may not have been connected to taking a medicine like tadalafil
• if you have previously experienced loss of hearing in one or both ears, with or without symptoms like vertigo and dizziness
• if you are taking any guanylate cyclase stimulators such as riociguat (this group of medicines is used to treat pulmonary hypertension) as taking these medicines with TADALAFIL DYNA may cause low blood pressure

Use with care, and tell your doctor, if

• if you are taking medicines to control your blood pressure as the dosage of these medicines might have to be adjusted to prevent your blood pressure from dropping too low
• if you notice any symptoms or feel any discomfort when you begin sexual activity, stop immediately and report the incident to your doctor
• if you experience sudden loss of vision or any change in vision let your doctor know immediately
• if you experience a sudden loss of hearing or decrease in ability to hear, advise your doctor immediately. You may experience dizziness and ringing in your ears with this loss of hearing
• if you have kidney or liver disease
• if you experience prolonged erections (4 hours or more) while taking tadalafil. If this is not treated immediately it can lead to permanent damage and loss of potency
• if you have any malformations of the penis
• if you are taking other medication for erectile dysfunction as TADALAFIL DYNA should not be taken with certain other medicines
• it is not known if TADALAFIL DYNA is effective in patients who have had: o pelvic surgery o removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-sparing prostatectomy). Children and adolescents TADALAFIL DYNA is not intended for use by children and adolescents under the age of 18

Pregnancy and breastfeeding

• TADALAFIL DYNA is not indicated for use in women
• If you and your partner are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine
• You should not use this medicine during pregnancy
• You should not breast-feed while using TADALAFIL DYNA

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines to control your blood pressure
• ketoconazole, itraconazole (used to treat fungal infections)
• rifampicin (used to treat tuberculosis)
• medicines used for the treatment and control of seizures (fits)
• ritonavir, saquinavir (used in the treatment of HIV/AIDS)
• antacids (used to neutralise acid in the stomach)
• nitrates for angina (chest pains), see Do not take TADALAFIL DYNA
• any other treatments for erectile dysfunction as the safety of these combinations has not been studied. TADALAFIL DYNA with food and drink and alcohol
• TADALAFIL DYNA may be taken with or without food
• Grapefruit juice may affect how well TADALAFIL DYNA will work and should be taken with caution
• Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take TADALAFIL DYNA, avoid excessive drinking (blood alcohol level of 0,08 % or greater), since this may increase the risk of dizziness when standing up

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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