Patient leaflet - Ketoconazole 2% shampoo
1. What Ketoconazole Shampoo is and what it is used for
The name of your medicine is “Ketoconazole 2% Shampoo (Ketoconazole)” but will be referred as “Ketoconazole Shampoo” in this leaflet.
Ketoconazole Shampoo contains a medicine called ketoconazole. This belongs to a group of medicines called ‘Antifungals’. Like other shampoos, it also contains ingredients to clean your hair.
Ketoconazole shampoo is used for fungal infections on the scalp and body such as:
- Dandruff
Dry or greasy scaling of the scalp and other parts of the
body called ‘seborrhoeic dermatitis’
White to brown patches on the body that sometimes
appear after being in the sun called ‘tinea versicolor’ or ‘pityriasis versicolor’
These conditions can be itchy. They are caused by a fungus (yeast) called ‘Malassezia’. This fungus is found on everyone’s skin, but sometimes it can overgrow and cause problems. Ketoconazole Shampoo works by killing the fungus and stopping it from coming back.
2. What you need to know before you use Ketoconazole Shampoo
Do not use Ketoconazole Shampoo if:
You are allergic to anything in Ketoconazole Shampoo
(listed in section 6 below) Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Ketoconazole Shampoo.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:
If you use a lotion or cream on your hair that contains a
steroid, such as betamethasone or hydrocortisone:
You should use less and less of the lotion or cream
during the first 2 to 3 weeks of Ketoconazole Shampoo treatment
This will stop your condition flaring up while
Ketoconazole Shampoo starts to work
If you have any questions about stopping your steroid lotion or cream, ask your doctor or pharmacist.
Children and adolescents
Ketoconazole Shampoo is not recommended for use in infants and children.
Other medicines and Ketoconazole Shampoo
Ketoconazole Shampoo does not normally react with other medicines. However, tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Pregnancy and breast-feeding
Ketoconazole Shampoo can be used if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Ketoconazole Shampoo is not likely to affect you being able to drive or use any tools or machines.
Excipient warnings:
This medicine contains 24% w/w sodium lauryl ether sulfate in each application. Sodium lauryl ether sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
3. How to use Ketoconazole Shampoo
Always use this medicine exactly as your doctor has told you. Ketoconazole Shampoo is for use on your hair or skin only. Check with your doctor or pharmacist if you are not sure.
How often you should use Ketoconazole Shampoo
The recommended dose is:
For dandruff or dry or greasy scaling of the skin
- Start by using the Ketoconazole Shampoo twice a week
- You should use it every 3 or 4 days for 2 to 4 weeks
- You should then use the Ketoconazole Shampoo once every 1 to 2 weeks to stop the symptoms coming back
- Do not use the Ketoconazole Shampoo more often than your doctor has told you
For white to brown patches on the skin
- You should use the Ketoconazole shampoo on the white to brown patches of skin once daily for 1 - 5 days
- Do not use the Ketoconazole shampoo more often than your doctor has told you
Using Ketoconazole Shampoo
Wash your hair or infected part of skin with the
Ketoconazole Shampoo
- Leave it on for 3 to 5 minutes
- Rinse thoroughly
If Ketoconazole Shampoo gets in your eyes
Gently bathe your eyes in cold water.
Using your normal shampoo
If you need to wash your hair between treatments, use
a normal shampoo
If your hair is very thick or long, you can wash it with your
usual shampoo and then use Ketoconazole Shampoo
If you swallow Ketoconazole Shampoo
If you swallow any shampoo, tell your doctor straight away.
If you forget to use Ketoconazole Shampoo
If you miss a treatment with Ketoconazole Shampoo,
you should use it as soon as you remember
Do not use the Ketoconazole shampoo twice to make
up for a missed treatment
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Ketoconazole Shampoo and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Allergic reaction, swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or breathing. This can affect fewer than 1 in 1000 people
Severe irritation or reddening of the skin where the
Ketoconazole shampoo has been used, or other signs of allergy during the first few days of treatment. This can affect fewer than 1 in 100 people Peeling or blistering of the skin. This can affect fewer than 1 in 1000 people
Tell your doctor or pharmacist if you notice or suspect any of the following side effects:
Uncommon side effects (affects fewer than 1 in 100 people)
- Infection of the hair roots
- Increase in production of tears
- Unusual hair loss or thinning
- Dry skin, rash, burning feeling
- Changes in how your hair feels
Rare side effects (affects fewer than 1 in 1000 people)
- Taste impairment
- Irritation of the eyes
- Acne
- Flaking skin
The following side effects have been reported, however the precise frequency cannot be identified and therefore, how often they occur is classed as unknown
- Hives (also known as nettle rash or urticaria)
- Hair colour changes
Reporting of side-effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ketoconazole Shampoo
Keep out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions.
Store in the original pack to protect from light. After first opening use within 60 days.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ketoconazole Shampoo contains
The active substance is ketoconazole.
Each gram (g) of shampoo contains 20 milligrams (mg) of ketoconazole (2 % w/w).
The other ingredients
Cocodiethanolamide, Disodium Laureth Sulfosuccinate,
Allura red AC (E129), Hydrochloric Acid, Imidurea, Laurdimonium Hydroxypropyl Hydrolyzed Collagen, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Sodium Lauryl Ether Sulphate, Sodium Hydroxide and Purified Water.
What Ketoconazole Shampoo look like and contents of the pack
Ketoconazole shampoo comes in a High-density polyethylene bottle containing 120 ml of reddish orange shampoo.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Zydus Pharmaceuticals UK Ltd
Sandretto Building Weedon
Northampton NN7 4PP UK
This leaflet was last revised in Jan-2026.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 9956034 / email: DrugSafety@ZydusUK. com
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