This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cystadane (Betaine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (20)
Death (2)
Disability (1)
Reports by Reaction Type
Blood Homocysteine Increased (6),
Drug Dose Omission (3),
Pyrexia (3),
Maternal Exposure During Pregnancy (3),
Convulsion (3),
Diarrhoea (3),
Abdominal Pain (2),
Nasopharyngitis (2),
Partial Seizures (2),
Influenza (2),
Abortion Induced (2),
Decreased Appetite (2)
Possible Cystadane side effects in 17 year old male
Reported by a individual with unspecified qualification from France on 2012-07-24
Patient: 17 year old male
Reactions: Back Pain, Blood Homocysteine Increased, Measles, Pneumococcal Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 10 g every day oral
Administration route: Oral
Indication: Vitamin B12 Deficiency
Cystadane
Dosage: 400 mg every day, 10 g every day
Indication: Vitamin B12 Deficiency
Start date: 1998-08-10
Cystadane
Dosage: 400 mg every day, 10 g every day
Indication: Vitamin B12 Deficiency
Start date: 2001-04-01
Other drugs received by patient: Leucovorin Calcium; L-Carnitine; Vitamin B-12; Vitamin B-12
Possible Cystadane side effects in male
Reported by a individual with unspecified qualification from France on 2012-07-20
Patient: male
Reactions: Marfan's Syndrome, Wrist Fracture, Blood Homocysteine Increased, Abnormal Behaviour, Pulmonary Embolism, Enuresis, Kyphosis, Amino Acid Level Increased, Mitral Valve Incompetence, Amino Acid Level Decreased, Inguinal Hernia
Drug(s) suspected as cause:
Cystadane
Dosage: 4 g /1 days, 3 g every day, 4 g every day, 3 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2010-09-07
Cystadane
Dosage: 4 g /1 days, 3 g every day, 4 g every day, 3 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2009-04-09
End date: 2010-04-20
Cystadane
Dosage: 4 g /1 days, 3 g every day, 4 g every day, 3 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2000-11-12
End date: 2009-04-08
Cystadane
Dosage: 4 g /1 days, 3 g every day, 4 g every day, 3 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2010-04-21
End date: 2010-09-06
Other drugs received by patient: Vitamin B6; Folic Acid; Vitamin B-12
Possible Cystadane side effects in 12 month old male
Reported by a individual with unspecified qualification from France on 2012-07-18
Patient: 12 month old male
Reactions: Blood Glucose Decreased, Abdominal Pain, Laboratory Test Abnormal, Blood Homocysteine Increased, Conjunctivitis, Gastroenteritis, Eczema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 300;600 mg every day, oral powder
Administration route: Oral
Indication: Vitamin B12 Deficiency
Start date: 2008-10-27
Cystadane
Dosage: 300;600;1200 mg every day, oral, powder
Administration route: Oral
Indication: Vitamin B12 Deficiency
Start date: 2008-10-27
Other drugs received by patient: Leucovorin Calcium; L-Carnitine; Vitamin B-12
Possible Cystadane side effects in 25 year old female
Reported by a individual with unspecified qualification from France on 2012-05-17
Patient: 25 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Folic Acid; Hydroxocobalamin; Pyridoxine HCL; Heparin
Possible Cystadane side effects in 25 year old female
Reported by a individual with unspecified qualification from France on 2012-05-08
Patient: 25 year old female
Reactions: Blood Homocysteine Increased, Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Hydroxocobalamin; Heparin; Pyridoxine HCL; Folic Acid
Possible Cystadane side effects in 10 year old male
Reported by a individual with unspecified qualification from Spain on 2012-03-12
Patient: 10 year old male
Reactions: Tachycardia, Brain Oedema, Depressed Level of Consciousness, Cerebral Thrombosis, Intracranial Pressure Increased, Septic Shock, Hypertonia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Vitamin B6; Folic Acid
Possible Cystadane side effects in male
Reported by a individual with unspecified qualification from Spain on 2012-03-12
Patient: male
Reactions: Paraparesis, Neuropathy Peripheral, Blood Homocysteine Increased, Incorrect Dose Administered, Myelopathy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 1 200 mg every day, 6 g every day, 7 g every day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2007-06-28
End date: 2009-08-26
Cystadane
Dosage: 1 200 mg every day, 6 g every day, 7 g every day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2010-09-01
End date: 2011-08-23
Cystadane
Dosage: 1 200 mg every day, 6 g every day, 7 g every day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2009-08-27
End date: 2010-08-31
Other drugs received by patient: Folic Acid; Vitamin B-12; L-Carnitine
Possible Cystadane side effects in 17 year old male
Reported by a individual with unspecified qualification from Spain on 2012-03-12
Patient: 17 year old male
Reactions: Foot Fracture, Retinal Detachment
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Vitamin B6; Folic Acid
Possible Cystadane side effects in 3 year old male
Reported by a individual with unspecified qualification from France on 2012-03-12
Patient: 3 year old male
Reactions: Vomiting, Nasopharyngitis, Ear Infection, Tonsillitis, Pyrexia, Ecchymosis, Asthenia, Decreased Appetite, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Coumadin; Keppra (Leveetiracetam); Kardegic (Lysine Acetylsalicylate); Becilan (Pyridoxine); Dodecavit (Vitamin B12); Lovenix (Enoxaparin Sodium); Speciafoldine (Folic Acid); Cystine B6 (Cystine / Vitamin B6)
Possible Cystadane side effects in 3 year old female
Reported by a individual with unspecified qualification from Spain on 2012-03-12
Patient: 3 year old female
Reactions: Grand MAL Convulsion, Partial Seizures, Ataxia, Abnormal Behaviour, Toxicity To Various Agents
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 1 250 mg every day, 3,600 g every day, 5, 400 day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2009-02-18
Cystadane
Dosage: 1 250 mg every day, 3,600 g every day, 5, 400 day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2010-11-15
Cystadane
Dosage: 1 250 mg every day, 3,600 g every day, 5, 400 day, oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2008-07-18
Other drugs received by patient: Leucovorin Calcium; Vitamin B-12
Possible Cystadane side effects in 28 year old male
Reported by a individual with unspecified qualification from France on 2012-03-12
Patient: 28 year old male
Reactions: Diarrhoea, Urinary Incontinence, Pollakiuria, Condition Aggravated, Arachnodactyly, Arthrodesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 8 g every day, oral; 10 g every day
Administration route: Oral
Indication: Homocystinuria
Start date: 1999-06-21
End date: 2009-11-15
Cystadane
Dosage: 8 g every day, oral; 10 g every day
Administration route: Oral
Indication: Homocystinuria
Start date: 2009-11-16
Other drugs received by patient: Leucovorin Calcium; Vitamin B-12; Vitamin B6; Lovenox
Possible Cystadane side effects in 3 year old female
Reported by a individual with unspecified qualification from Spain on 2012-03-07
Patient: 3 year old female
Reactions: Partial Seizures, Grand MAL Convulsion, Blood Homocysteine Increased, Ataxia, Vitamin B12 Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Oral Powder
Cystadane
Dosage: 1 000 mg every day
Administration route: Oral
Indication: Methylenetetrahydrofolate Reductase Deficiency
Start date: 2008-07-21
End date: 2009-01-14
Betaine Anhydrous
Dosage: 4 800 mg every day
Administration route: Oral
Start date: 2009-01-15
Possible Cystadane side effects in 28 year old male
Reported by a individual with unspecified qualification from France on 2012-03-05
Patient: 28 year old male
Reactions: Diarrhoea, Urinary Incontinence, Pollakiuria, Condition Aggravated, Arthrodesis, Arachnodactyly
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 8 g every day, 10 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 1999-06-21
End date: 2009-11-15
Cystadane
Dosage: 8 g every day, 10 g every day oral
Administration route: Oral
Indication: Homocystinuria
Start date: 2009-11-16
Other drugs received by patient: Vitamin B-12; Leucovorin Calcium; Lovenox; Enoxaparin Sodium; Vitamin B6
Possible Cystadane side effects in female
Reported by a individual with unspecified qualification from France on 2012-03-05
Patient: female
Reactions: Musculoskeletal Pain, Maternal Exposure During Pregnancy, Chills, Pyrexia, Musculoskeletal Chest Pain, Abortion Spontaneous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Metformin HCL; Irbesartan; Irbesartan; Glucophage; Lysine-Acetylsalycylate; Aspegic 1000
Possible Cystadane side effects in 6 year old female
Reported by a individual with unspecified qualification from France on 2012-02-21
Patient: 6 year old female
Reactions: Blood Alkaline Phosphatase Increased, Neutrophil Percentage Increased, Abdominal Pain, Vomiting, Blood Urea Increased, Nasopharyngitis, Nausea, Body Temperature Increased, Blood Lactate Dehydrogenase Increased, Varicella, Pyrexia, Diarrhoea, C-Reactive Protein Increased, Heart Rate Increased, Gastroenteritis, Asthenia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Dosage: 350 mg every day
Administration route: Oral
Indication: Vitamin B12 Deficiency
Start date: 2010-01-23
Betaine Anhydrous
Dosage: 1 g every day
Administration route: Oral
Start date: 2010-08-23
Oral Powder
Dosage: 1,500 g every day
Start date: 2011-02-17
Other drugs received by patient: Folic Acid; Vitamin B6; L-Carnitine; Vitamin B-12
Possible Cystadane side effects in male
Reported by a individual with unspecified qualification from France on 2012-02-10
Patient: male
Reactions: Osteonecrosis of JAW, Haematuria, Dermal Cyst, Varicose Ulceration, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Calcium Sandoz -Calcium; Becilan -Pyridoxine; Speciafoldine -Carbamazepine; Vitamin B-12; Plavix; Cystine B6 -L-Cystine; Pravastatin; Tegretol; Speciafoldine -Folic Acid; Forteo
Possible Cystadane side effects in 6 year old male
Reported by a consumer/non-health professional from United States on 2012-01-20
Patient: 6 year old male
Reactions: Drug Dose Omission, Convulsion
Drug(s) suspected as cause:
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2012-01-10
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2010-12-28
Possible Cystadane side effects in 6 year old male
Reported by a consumer/non-health professional from United States on 2012-01-17
Patient: 6 year old male
Reactions: Confusional State, Drug Dose Omission, Convulsion
Drug(s) suspected as cause:
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2012-01-10
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2010-12-28
Other drugs received by patient: Loratadine; Guanfacine Hydrochloride; Oxybutynin; Nitrofurantoin (Furadantin); Amphetamine / Dextroamphetamine (Adderall); Polyethylene Glycol 3350 (Miralax); Hydrococobalamin
Possible Cystadane side effects in 6 year old male
Reported by a consumer/non-health professional from United States on 2012-01-17
Patient: 6 year old male
Reactions: Drug Dose Omission, Disease Recurrence, Convulsion
Drug(s) suspected as cause:
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2012-01-10
Cystadane
Dosage: 3 grams every day
Indication: Homocystinuria
Start date: 2010-12-28
Possible Cystadane side effects in female
Reported by a physician from United States on 2012-01-10
Patient: female
Reactions: General Physical Health Deterioration, Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Cystadane
Other drugs received by patient: Levocaritine; Folic Acid; Enalapril Maleate; Pepcid; Keppra; Aspirin
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