What is tranexamic acid? Melasma, side effects, how to take it and treatment reviews

Prescribing Transamin for melasma falls outside its approved indications in Japan. At our clinic, the doctor assesses your skin and medical history before deciding. Not every area of pigmentation that you regard as a “dark spot” is melasma, so treatment should not be chosen by a medicine's name alone.

How have its effects on melasma been studied?

Clinical studies have examined its use for melasma. A double-blind randomized controlled trial at a single center outside Japan enrolled 44 people with moderate-to-severe melasma; 39 completed the trial. Both groups used sunscreen and took either tranexamic acid or placebo for 3 months. The tranexamic acid group showed a greater improvement in the modified Melasma Area and Severity Index (mMASI). Del Rosario et al.: randomized trial in melasma

However, this was a small study, and most participants were Hispanic women. The findings cannot be assumed to apply to every type of pigmentation or every person, and the study was not large enough to adequately assess rare adverse events. These results do not mean that the treatment is approved for melasma in Japan or that the same effects have been established for the product and dose used at our clinic. They should inform a discussion with a doctor about expectations and risks after a skin assessment and review of your medical history.

How is it different from OTC melasma medicines?

Transino EX is an OTC combination medicine containing tranexamic acid that is approved in Japan for melasma, a specific type of pigmentation. However, its combination of ingredients and directions differ from prescription Transamin. The indications or treatment duration for an OTC product cannot simply be applied to a prescription single-ingredient medicine. Manufacturer: Transino EX package insert / Product information

Check the strength of your prescribed product and follow your doctor's instructions. Different products may contain different amounts of the active ingredient even when described as “one tablet.” Also check your own prescription and dispensing label for how often and when to take it.

Do not treat the dose for an approved indication as a standard dose for melasma, or calculate and increase the number of tablets yourself. Transamin prescribing information, section 6

Melasma treatment involves protection from sunlight as well as medication. Alongside sunscreen, combine measures such as wearing a hat and seeking shade. Taking tranexamic acid does not replace sunscreen. American Academy of Dermatology: melasma treatment and sun protection

If sunscreen or a topical medicine irritates your skin, consult your doctor instead of forcing yourself to continue using it. Choose care suitable for your skin and review it together with your response to treatment.

If you suddenly develop difficulty breathing or severe chest pain, or your lips, tongue or throat suddenly swell while taking the medicine, seek emergency care without waiting for a routine online appointment. In Japan, call 119 for an ambulance. These symptoms require urgent assessment for possible blood clots, severe allergy or other causes.

Also seek prompt medical advice if you develop pain, swelling or redness in a limb on one side, or changes in your vision. Tell the clinician the medicine's name and how you have been taking it, and ask what to do about your next dose. NHS: side effects of tranexamic acid and when to seek help

Even if symptoms seem mild, contact the prescriber if a rash, nausea or other symptoms persist. Do not keep taking it while simply putting up with symptoms, or increase the dose yourself.

The Japanese prescribing information for Transamin states that it should be used during pregnancy only when the therapeutic benefit outweighs the risk. During breastfeeding, a decision also needs to consider the benefits of treatment and breastfeeding. Do not take it for cosmetic purposes on your own; discuss possible pregnancy or breastfeeding with your doctor. Transamin prescribing information, sections 9.5 and 9.6

Transamin is stored at room temperature. Follow the instructions on the dispensing label or packaging provided. Remove tablets from blister packaging before taking them; do not swallow the packaging. Transamin prescribing information: storage and section 14

If you notice a change in appearance or damaged packaging, do not judge quality or whether it can be used by color alone. Ask the medical institution or pharmacy that supplied the medicine.

1. Distinguish melasma from other pigmentation and understand the explanation of off-label use.
2. Check the product strength and prescription instructions; do not increase the dose yourself.
3. Tell the doctor about blood clots, kidney function, pregnancy and breastfeeding.
4. Share all other medicines, including OTC products, so overlapping ingredients can be checked.
5. Continue sun protection and review your skin response and general health with the doctor when deciding whether to continue.