Cystadane Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Cystadane (betaine anhydrous 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 plasma levels (see DOSAGE AND ADMINISTRATION). Response usually occurs within a week and steady state within a month.

Cystadane has been administered concomitantly with vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate.


There is currently no drug history available for this drug.

Other Information

Cystadane® (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. Cystadane is a white, granular, hygroscopic powder. It contains no ingredients other than anhydrous betaine. Betaine anhydrous powder is very soluble in water, soluble in methanol and ethanol, and sparingly soluble in ether.

The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:

Image from Drug Label Content

Cystadane Manufacturers

  • Jazz Pharmaceuticals, Inc.
    Cystadane (Betaine, Anhydrous) Powder, For Solution [Jazz Pharmaceuticals, Inc.]
  • Rare Disease Therapeutics, Inc.
    Cystadane (Betaine) Powder, For Solution [Rare Disease Therapeutics, Inc.]

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