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Betaine Side Effects

The most commonly reported side effects of betaine include off label use, overdose, and vomiting, based on 1,231 FDA adverse event reports from 2004 to 2025. 2.4% of reports found the drug to be ineffective.

Betaine side effects

Percentages show how often each reaction appears relative to total reports for betaine.

1
Off Label Use12.5%154
2
Overdose7.1%88
3
Vomiting6.7%82
4
Diarrhoea5.7%70
5
Nausea5.4%67
6
Product Dose Omission4.5%55
7
Seizure3.6%44
8
Product Dose Omission Issue3.5%43
9
Product Use Issue3.3%41
10
Pyrexia3.2%40
11
Headache3.2%40
12
Pneumonia3.2%39
13
Abdominal Discomfort3.1%38
14
Inappropriate Schedule Of Product Administration3.0%37
15
Influenza2.8%35

These are voluntary reports and do not establish that betaine caused these reactions.

Report severity

63.3%Serious779 reports
35.8%Hospitalizations441 reports
6.7%Fatal82 reports

Seriousness is determined by the reporter, not by OpenClaim.

Betaine drug interactions

Other drugs that appear in adverse event reports alongside betaine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-oxybate3.7%45
2
Alendronate-sodium0.7%9
3
Prednisone0.7%9
4
Ranitidine0.6%8
5
Adalimumab0.6%7
6
Acetaminophen0.6%7
7
Cyanocobalamin0.6%7
8
Pregabalin0.6%7
9
Dupilumab0.6%7
10
Duloxetine-hydrochloride0.5%6
11
Hydroxocobalamin0.5%6
12
Levetiracetam0.5%6
13
Hydrochlorothiazide0.5%6
14
Lenalidomide0.5%6
15
Baclofen0.5%6

Taken alongside

1
Folic-acid20.2%249
2
Ergocalciferol17.7%218
3
Cyanocobalamin17.1%210
4
Hydroxocobalamin12.3%151
5
Aspirin11.3%139
6
Levocarnitine11.0%136
7
Ascorbic-acid8.0%98
8
Calcium7.9%97
9
Acetaminophen7.2%89
10
Levothyroxine-sodium6.7%83
11
Albuterol6.1%75
12
Gabapentin5.0%61
13
Fluticasone5.0%61
14
Omeprazole5.0%61
15
Levetiracetam4.8%59

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports betaine side effects

39.7% of betaine adverse event reports involve female patients and 36.0% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.7%
Male36.0%
Unknown24.3%

Age group

< 26.8%
2–1121.2%
12–179.0%
18–6446.5%
65+16.6%

What is betaine used for

Conditions and purposes for which patients were taking betaine when the adverse event was reported.

Abdominal DiscomfortAbdominal DistensionAbdominal PainAchlorhydriaAcidosisAmino Acid Catabolism DisorderAmino Acid Level IncreasedAmino Acid Metabolism DisorderAngelman^s SyndromeAmino Acid Level AbnormalAmino Acid Level IncreasedAmino Acid Metabolism DisorderAnaemiaAnaemia Vitamin B12 DeficiencyBlood Disorder

Showing 15 of 81 indications

Betaine brand names and reporting trend

Betaine is sold under the brand name Cystadane.

Brand names

Cystadane375

Quarterly reports (20042025)

20042010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking betaine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.