Home FDA labels 7D587A24-732D-934E-FCA3-381D68D37BBC FDA label 7D587A24-732D-934E-FCA3-381D68D37BBC openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 05964DAE-8B84-467C-AF97-C82706A3CAD2
SPL ID 7D587A24-732D-934E-FCA3-381D68D37BBC
Version 1
Effective date 2007-03-31
Source export date 2026-10-12
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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adverse reactions ADVERSE REACTIONS Adverse reactions to betaine have been minimal. In a survey study of physicians who had treated a total of 111 homocystinuria patients with betaine, the types of adverse effects and the number of patients experiencing them were as follows: Nausea 2 “Caused odor” 1 GI distress 2 Questionable psychological changes 1 Diarrhea 1 “Aspirated the powder” 1 Unspecified problem 1 A few cases of cerebral edema have been reported secondary to severe hypermethioninemia in patients with cystathionine beta-synthase (CBS) deficiency treated with Cystadane. See PRECAUTIONS : Hypermethioninemia .
adverse reactions table <table ID="ID_439E6994-DC89-45DF-B304-64B67C2A4B55" border="single" frame="box" width="360.79999999999995"> <col width="33.315%"/> <col width="4.850%"/> <col width="56.984%"/> <col width="4.850%"/> <tbody> <tr ID="ID_BE81B5C2-D957-41EF-9A2F-8DC536242A41"> <td align="left" valign="top">Nausea</td> <td align="left" valign="top">2</td> <td align="left" valign="top">“Caused odor”</td> <td align="left" valign="top">1</td> </tr> <tr ID="ID_CE04FAB9-7290-482D-901D-2ACD808A820E"> <td align="left" valign="top">GI distress</td> <td align="left" valign="top">2</td> <td align="left" valign="top">Questionable psychological changes</td> <td align="left" valign="top">1</td> </tr> <tr ID="ID_6195ABD8-E489-49F6-8D32-9DE149F593E7"> <td align="left" valign="top">Diarrhea</td> <td align="left" valign="top">1</td> <td align="left" valign="top">“Aspirated the powder”</td> <td align="left" valign="top">1</td> </tr> <tr ID="ID_0A062E59-4851-48D8-B86F-BF03A2B27F61"> <td align="left" valign="top">Unspecified problem</td> <td align="left" valign="top">1</td> <td align="left" valign="top"/> <td align="left" valign="top"/> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.