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Cystadane (Betaine) - Side Effect Reports to FDA

 
 



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)Abortion Induced (2)Influenza (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 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 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 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 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 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 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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