Applies to betaine: oral powder for solution, oral tablet.
Serious side effects of Betaine
Along with its needed effects, betaine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Other side effects of Betaine
Some side effects of betaine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Diarrhea
- nausea
- stomach upset
Betaine may cause a body odor. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
For Healthcare Professionals
Applies to betaine: compounding powder, oral powder for reconstitution.
Gastrointestinal
Common (1% to 10%): Nausea, gastrointestinal distress
Uncommon (0.1% to 1%): Diarrhea
Postmarketing reports: Dental disorders, glossitis, stomach discomfort, vomiting[Ref]
Nervous system
Postmarketing reports: Cerebral edema[Ref]
Severe cerebral edema and hypermethioninemia have occurred with 2 weeks to 6 months of starting therapy, with complete recovery after discontinuation. All patients had cystathionine beta-synthase (CBS) deficiency with hypermethioninemia and severe plasma methionine elevations (1000 to 3000 micromol/L). The mechanism of action is postulated as secondary hypermethioninemia due to betaine therapy.[Ref]
Other
Uncommon (0.1% to 1%): "Bad taste", "caused odor", questionable psychological changes, "aspirated the powder"
Postmarketing reports: Severe elevation in plasma methionine[Ref]
Psychiatric
Postmarketing reports: Agitation, depression, irritability, personality disorder, sleep disturbed[Ref]
Dermatologic
Postmarketing reports: Hair loss, hives, skin odor abnormality[Ref]
Metabolic
Postmarketing reports: Anorexia[Ref]
Genitourinary
Postmarketing reports: Urinary incontinence[Ref]
