Betaine
Amino Acids and Derivatives
Sold as CYSTADANE · GUNA-AWARENESS
- Drug class
- Amino Acids and Derivatives
- Availability
- Over-the-counter
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 4
- FDA reports (12 mo)
- 69
Overview
Betaine is an active pharmaceutical ingredient in the Amino Acids and Derivatives group (A16AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 2 | April 10, 2026 |
| US United States | FDA | 1 | November 15, 2022 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
2 products
Uses
Adjunctive treatment of homocystinuria, involving deficiencies or defects in: • cystathionine beta-synthase (CBS), • 5,10-methylene-tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl). Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
How to take
USUnited States· FDA
1 product
Uses
Take 15 minutes before meals
How to take
CACanada· Health Canada
1 product
Uses
7 cc scoop none For a complete listing see Dosage Forms, Composition and Packaging section INDICATIONS AND CLINICAL USE CYSTADANE (betaine anhydrous powder for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.
Included within the category of homocystinuria are deficiencies or defects in: 1. cystathionine beta-synthase (CBS), 2. 5,10-methylenetetrahydrofolate reductase (MTHFR), 3. cobalamin cofactor metabolism (cbl). Patient response to CYSTADANE can be monitored by homocysteine and methionine plasma levels (See DOSAGE AND ADMINISTRATION).
Response usually occurs within a week and maximum response within four to six weeks. Cystadane® Product Monograph Page 4 of 19 CYSTADANE has been administered concomitantly with vitamin B6 (pyridoxine), B12 (cobalamin), and folate.
Geriatrics:
Clinical data differentiating younger adults and adults >65 years are not available.
Sources & citations
- [1]MHRA (UK) · PLGB152660020 · revised April 10, 2026
- [2]FDA DailyMed · 10e46b39-7903-43… · revised November 15, 2022 [PDF]
- [3]Health Canada (DPD) · 02238526 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.