Fluconazole Side Effects

Home › Medicine Side Effects › fluconazole

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

What is fluconazole?

Fluconazole contains the active ingredient Fluconazole.

• Active ingredient — Fluconazole
• Registration number — 48/20.2.2/0455
• Registration holder — B. Braun Medical (Pty) Ltd

It is approved for:

• Fluconazole B Braun is one of a group of medicines called ‘antifungals’
• The active substance is fluconazole
• Fluconazole B Braun I.V Infusion is used to treat infections caused by fungi including yeasts and may also be used to stop you from getting a fungal infection

Common side effects of fluconazole

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
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash

Less frequent side effects

• reduction in red blood cells which can make skin pale and cause weakness of breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
• constipation, difficult digestion, wind, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• wheals, blistering (hives), itching, increased sweating
• tiredness, general feeling of being unwell, fever
• lower normal white blood cells that help defend against infections and blood cells that help to stop bleeding
• red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
• blood chemistry changes (high blood levels of cholesterol, fats)
• shaking
• low blood potassium
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• liver failure
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
• hair loss If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet

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

• are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Fluconazole B Braun. The symptoms may include itching, reddening of the skin or difficulty in breathing
• are taking astemizole, terfenadine (antihistamine medicines for allergies)
• are taking cisapride (used for stomach upsets)
• are taking pimozide (used for treating mental illness)
• are taking quinidine (used for irregular/uneven heartbeats)
• are taking erythromycin (an antibiotic for treating infections)
• are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• if you have liver or kidney problems
• if you suffer from heart disease, including heart rhythm problems
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
• If you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using Fluconazole B Braun
• if the fungal infection does not improve, as alternative antifungal therapy may be needed. Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Fluconazole B. Braun treatment. Stop using Fluconazole B. Braun and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4

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 this medicine
• You should not be given Fluconazole B Braun if you are pregnant, think you may be pregnant, are trying to become pregnant or breastfeeding, unless your doctor has told you to
• Fluconazole B Braun may harm your baby
• Fluconazole B Braun taken during the first trimester of pregnancy may increase the risk of miscarriage
• Fluconazole taken at low doses during the first trimester may slightly increase the risk of a baby being born with birth defects affecting the bones and/or muscles
• You should not be given Fluconazole B Braun if you breastfeed you baby as it may harm your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• rifampicin or rifabutin (antibiotics for treating tuberculosis)
• alfentanil, fentanyl (used as anaesthetic)
• amitriptyline, nortriptyline (used as anti-depressant)
• amphotericin B, voriconazole (anti-fungal)
• medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines used to help you sleep or for anxiety)
• carbamazepine, phenytoin (used for treating fits)
• nifedipine, isradipine, amlodipine, felodipine and losartan (used for
• hypertension/high blood pressure)
• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines used for treating cancer)
• halofantrine (used for treating malaria)
• statins (atorvastatin, simvastatin, fluvastatin or similar medicines used for reducing high cholesterol levels)
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam and diclofenac (Non- Steroidal Anti-Inflammatory Drugs (NSAID) used for pain and inflammation)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• vitamin A (nutritional supplement)
• ivacaftor (used for treating cystic fibrosis)
• amiodarone (used for treating irregular/uneven heartbeats )
• hydrochlorothiazide (a diuretic)

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.

Related pages

• minoxidil side effects

← Back to more medicine side effects.