Betaine
Betaine is an ingredient used in oral powder products to treat homocystinuria (a rare metabolic disorder causing dangerous amino acid buildup), and in a topical product as a skin protectant.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Betaine: Patient Information Guide
A plain-language walkthrough of Betaine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Betaine is an ingredient found in multiple products used for distinct purposes depending on the form and brand.
- Betaine Anhydrous For Oral Solution, Betaine Anhydrous, Betaine (oral powder), and Cystadane are all oral powder products used to treat homocystinuria — a rare inherited metabolic disorder — by lowering elevated homocysteine levels in the blood. They are approved for both pediatric and adult patients.
- These oral products are used specifically in three types of homocystinuria: CBS (cystathionine beta-synthase) deficiency, MTHFR (5,10-methylenetetrahydrofolate reductase) deficiency, and cobalamin cofactor metabolism (cbl) defect.
- Dr. Jucre Rebirth Activating Toner is a topical product containing betaine used as a skin protectant applied directly to the skin.
⚙️How it works▾
In homocystinuria, the body cannot break down homocysteine properly, causing it to build up to harmful levels. The oral betaine products work as a methyl group donor — they supply a small chemical unit that drives a reaction converting homocysteine into methionine, a different and useful amino acid. This lowers the dangerous homocysteine levels in the blood. Betaine is a natural compound in the body, derived from choline, and is also found in small amounts in beets, spinach, cereals, and seafood.
In patients with MTHFR deficiency or cobalamin cofactor defects, betaine also helps raise low levels of methionine and a related compound called SAM (S-adenosylmethionine), which are important for normal body function. Patients have been treated with these oral products for many years without evidence of the drug becoming less effective over time.
💊How it's taken▾
The oral betaine powder products are taken by mouth twice daily. The powder must be measured carefully with the measuring scoop that comes with the product, then dissolved completely in 4 to 6 ounces of water, juice, milk, or formula — or mixed with food — and taken right away after mixing.
- Dosing is individualized and adjusted by your doctor based on regular blood tests measuring your homocysteine (and in some cases methionine) levels.
- Children under 3 years old start at a lower dose that is increased gradually week by week under medical supervision.
- Treatment should always be directed by a physician experienced in managing homocystinuria.
🤒Side effects — in detail▾
The most commonly reported side effects from the oral betaine products are nausea and general stomach upset. Other reported side effects include:
- Diarrhea
- Vomiting
- Stomach discomfort
- Unpleasant taste
- Loss of appetite
- Body or skin odor changes
- Hair loss
- Hives
- Urinary incontinence (loss of bladder control)
- Mood or personality changes, agitation, irritability, or depression
The most serious reported reaction is cerebral edema (brain swelling) in patients with CBS deficiency whose methionine levels became very high — seek medical attention immediately if you develop a severe headache, confusion, or sudden changes in thinking.
⚠️Warnings & precautions▾
- Risk of brain swelling (cerebral edema) in CBS deficiency: Betaine converts homocysteine into methionine — but in patients who already have elevated methionine (common in CBS deficiency), this can push levels dangerously high. Severely high methionine has been linked to cerebral edema. This is the most serious known risk of the oral betaine products.
- Your doctor will monitor your methionine blood levels regularly. If levels rise too high, your diet may need to change and your dose may need to be reduced.
- Brain swelling has been reported within 2 weeks to 6 months of starting therapy in CBS-deficient patients with very high methionine levels; patients fully recovered after stopping the medication.
- For the topical product Dr. Jucre Rebirth Activating Toner: do not use on broken or wounded skin, avoid contact with eyes, and stop use if irritation or a rash develops.
🔀What it interacts with▾
The FDA labels for betaine oral products do not list specific drug, food, or supplement interactions. However, always tell your doctor and pharmacist about everything you take, since dosing is guided by ongoing blood tests.
- No specific drug-drug or drug-food interactions are listed in the oral betaine product labels.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- CBS deficiency: If your homocystinuria is caused by CBS deficiency, you are at higher risk for methionine buildup — your doctor will monitor your blood levels closely throughout treatment.
- Pregnancy: Limited data from case reports have not shown clear harm, but there is not enough information to be certain. Talk to your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is not known whether betaine passes into breast milk or affects a nursing baby. Discuss the risks and benefits with your doctor.
- Children: The oral betaine products are established as safe and effective in pediatric patients, including very young infants. Children under 3 years require a different starting dose adjusted gradually by a physician.
- No contraindications: The oral betaine product labels list no absolute contraindications — meaning there is no group categorically told not to use it — but medical supervision is essential for everyone.
🚑If you take too much▾
There is no reported information on what happens if a person takes too much betaine oral solution. Animal studies in rats showed that very high doses were fatal, but this has not been studied in humans.
If you suspect an overdose, contact Poison Control or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
The oral betaine products measurably lower homocysteine levels in the blood across all three types of homocystinuria — CBS deficiency, MTHFR deficiency, and cobalamin cofactor defects. An initial drop in homocysteine levels is typically seen within several days, and blood levels stabilize within about a month. In people with CBS deficiency, betaine treatment can cause significant increases in methionine levels — which requires monitoring. In patients with MTHFR deficiency or cobalamin defects, betaine also raises methionine and SAM levels, which are often low in those conditions.
🔬Pharmacokinetics — how your body processes it▾
Formal pharmacokinetic studies — measuring how the body absorbs, processes, and clears betaine — have not been conducted for these oral products. Blood levels of betaine have not been routinely measured in patients, and no relationship between betaine blood levels and homocysteine levels has been established. Dosing is therefore guided by monitoring homocysteine (and methionine) blood levels rather than by betaine concentrations.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Protect from moisture.
📄 Written from Betaine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Betaine
17 supplements and herbal products have documented interactions with Betaine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Betaine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is homocystinuria, and why do I need this medication for it? ▾
How do I prepare and take the oral powder correctly? ▾
What side effects should I expect, and which ones should make me call my doctor? ▾
I have CBS deficiency — is there anything extra I need to watch out for? ▾
Can I take this if I'm pregnant or breastfeeding? ▾
Does betaine stop working over time, and how will my doctor know if it's helping? ▾
Is Betaine available over the counter? ▾
When was Betaine first available? ▾
Who makes Betaine? ▾
💬 Answers drafted from Betaine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Betaine comes
Betaine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Oral solution
How this form is used
- Betaine Anhydrous For Oral Solution is used to treat homocystinuria and lower elevated homocysteine blood levels in adults and children
- Betaine Anhydrous is used to treat homocystinuria caused by CBS deficiency, MTHFR deficiency, or cobalamin cofactor metabolism defect
- Cystadane is used to treat homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients
- Betaine (oral powder) is used to treat homocystinuria and reduce high homocysteine levels in pediatric and adult patients
- Betaine Anhydrous For Oral Solution: measure the prescribed amount with the scoop provided, dissolve completely in 4–6 ounces of water, juice, milk, or formula, or mix with food, and take immediately
- Cystadane: measure the prescribed amount with the scoop provided, dissolve in 4–6 ounces of water, juice, milk, or formula until fully dissolved, or mix with food, and ingest right away
- Betaine Anhydrous: taken orally in divided doses twice daily; dose is adjusted by your doctor based on homocysteine blood level monitoring
- Betaine (oral powder): measure with the provided scoop, dissolve in 4–6 ounces of water, juice, milk, or formula until fully dissolved, or mix with food, and take immediately
Topical solution
How this form is used
- Dr.Jucre Rebirth Activating Toner is used on the skin as a skin protectant
- Dr.Jucre Rebirth Activating Toner: apply an appropriate amount evenly on the skin
- Dr.Jucre Rebirth Activating Toner: for external use only — avoid contact with eyes
- Dr.Jucre Rebirth Activating Toner: do not use on wounded or broken skin; replace the cap after each use
- Dr.Jucre Rebirth Activating Toner: stop use and consult a doctor if signs of irritation or rash appear
📊 Betaine across the U.S. market
How Betaine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Betaine is used
A general measure of how commonly Betaine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Betaine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Betaine prescribed? Of the 1,596 medications we measure, Betaine ranks #1,139 by Medicaid prescriptions — more than 29% of them.
Utilization by Betaine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
betaine 1000 MG Powder for Oral Solution
Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 562847
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Betaine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Betaine NDCs with Medicaid activity.
🔍 Compare Betaine products
A representative set of FDA-listed product records for Betaine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 1 g/g | Oral | Cosette Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 1 g/g | Oral | Eton Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 1 g/g | Oral | Lukare Medical, LLC | ANDA | View NDC → |
| 1 g/g | Oral | Oakrum Pharma, Llc | ANDA | View NDC → |
| 1 g/g | Oral | Recordati Rare Diseases × 3 listings | NDA | View NDC → |
| 💊Topical solution | ||||
| 0.001 g/100 mL | Topical | Naturecell Co., Ltd. | UNAPPROVED DRUG OTHER | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | AMINO GmbH | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited | BULK INGREDIENT | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Betaine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Betaine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Betaine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Betaine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1512 4 dose forms · 3 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 437937No current FDA listingClinical drug / strength (SCD) hydrochloride 300 MGRxCUI 2725631 -
Dose form (SCDF) Oral Solution RxCUI 437935In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 374870No current FDA listingClinical drug / strength (SCD) 300 MGRxCUI 199239 -
Dose form (SCDF) Powder for Oral Solution RxCUI 1806653In current FDA listingsClinical drug / strength (SCD) 1000 MGRxCUI 562847
Look up RxCUI 1512 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Betaine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Betaine belongs to the Methylating Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Recordati Rare Diseases is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.