Betaine: uses, dosing, side effects & brands
Betaine is a medicine sold in the U.S. under one brand, for homocystinuria. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Homocystinuria
- Available as
- Powder
- Sold as
- Cystadane
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How betaine is dosed
From the FDA label for Cystadane (application NDA020576). Other betaine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adults and Pediatric Patients 3 Years of Age and Older The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. ( 2.1 ) Pediatric Patients Less than 3 Years of Age The recommended starting dosage is 100 mg/kg/day, administered orally in divided doses of 50 mg/kg twice daily, and then increased weekly by 50 mg/kg increments. ( 2.1 ) Monitor patient response by plasma homocysteine concentrations. ( 2.1 ) Increase the dosage gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. ( 2.1 ) Preparation and Administration Instructions Prescribed amount of CYSTADANE should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula until completely dissolved, or mixed with food for immediate ingestion. ( 2.2 ) 2.1 Dosage Therapy with CYSTADANE should be directed by physicians knowledgeable in the management of patients with homocystinuria. Adults and Pediatric Patients 3 Years of Age and Older The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. Pediatric Patients Less than 3 Years of Age The recommended starting dosage is 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments. Monitoring Monitor patient response to CYSTADANE by homocysteine…
Betaine side effects
The following serious adverse reactions are described elsewhere in labeling: Hypermethioninemia and cerebral edema in patients with CBS deficiency [ see Warnings and Precautions ( 5.1 ) ]. Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with CYSTADANE. Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey. Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported (Table 1): Table 1: Number of Patients with Adverse Reactions to CYSTADANE by Physician Survey Adverse Reactions Number of Patients Nausea 2…
Who shouldn’t take betaine
None. None ( 4 )
Every betaine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Cystadane.
How long betaine keeps
No betaine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does betaine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about betaine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 439 reports naming betaine, and the FDA flagged 73% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue40 reports
- nausea39 reports
- headache28 reports
- dizziness25 reports
- diarrhoea22 reports
- fall22 reports
- asthenia21 reports
- arthralgia20 reports
Read these as a signal, not a rate. A report does not mean betaine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is betaine?
CYSTADANE (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. It contains no ingredients other than anhydrous betaine. CYSTADANE is a white, granular, hygroscopic powder, which is diluted in water and administered orally.
Can you take betaine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run betaine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does betaine come in?
Across the brands we track, betaine is currently marketed as powder, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic betaine?
We do not currently list a generic-labelled betaine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Betaine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/betaine
- MLA
- “Betaine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/betaine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for betaine on DailyMed (NIH) ↗.