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tiratricol

Emcitate · ATC code H03AA04

Also known as: Tiratrikol

Key facts
Active substance
tiratricol
Drug class
Thyroid hormone
ATC code
H03AA04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Emcitate 350 microgram dispersible tablets
Marketing authorisation holder
Rare Thyroid Therapeutics International AB
Information as of
2026-10-29

Key facts

Tiratricol is a thyroid hormone-like (thyromimetic) agent. It is used from birth to treat peripheral thyrotoxicosis in MCT8 deficiency (Allan-Herndon-Dudley syndrome).

What it is used for

  • Treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome), from birth (Emcitate).

Dosing

  • Emcitate 350 microgram dispersible tablets: titrate individually by thyroid hormone levels, increasing about every two weeks, generally until serum T3 is below the midpoint of the normal range for age.
  • 10 kg or above: starting dose 350 micrograms daily, increased by 350 micrograms every two weeks until maintenance.
  • Below 10 kg: starting dose 175 micrograms (half tablet) daily, increased by 175 micrograms every two weeks.
  • Give the daily dose in 1 to 3 doses. Do not exceed 80 micrograms/kg at 10-40 kg, 60 micrograms/kg at 40-60 kg and 50 micrograms/kg above 60 kg.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Hyperthyroidism for reasons other than MCT8 deficiency (e.g. Graves' disease).
  • Pregnancy.

Important warnings

  • Hypermetabolic signs (hyperhidrosis, irritability, anxiety, insomnia, tachycardia, diarrhoea) may occur at initiation or during titration; reduce the dose if they do not resolve within 2 weeks.
  • Caution in cardiac disease and diabetes.
  • Tiratricol cross-reacts with T3 in immunoassays; an LC/MS/MS method is recommended for T3 measurement.
  • Hepatic impairment: see the full text.

Side effects

  • Most common: hyperhidrosis (7%), diarrhoea (6%), irritability (2%), anxiety (2%) and nightmares (2%), usually at start or after dose increases and resolving within a few days.
  • Frequency not known: insomnia, tachycardia, hyperthermia.

Interactions

  • Antacids, charcoal, calcium, cationic resins (e.g. cholestyramine), iron and sucralfate may interfere with absorption; separate by more than 2 hours if possible.
  • See the full text for other possible interactions (including antidiabetic medicines).

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; tiratricol crosses the placenta. Women of childbearing potential must use contraception.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • EmcitateRare Thyroid Therapeutics International AB · EMEA/H/C/005220

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Emcitate
Liechtenstein
Emcitate
Norway
Emcitate

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Emcitate – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/emcitate-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC H03AA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.