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Cystadane

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Cystadane

Cystadane Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cystadane (betaine anhydrous for oral solution) is used to reduce homocysteine levels in people with a genetic condition called homocystinuria, in which the amino acid builds up in the body. It is not a cure for homocysteinuria. This medication works by decreasing blood levels of homocysteine. Common side effects include nausea, stomach upset, or diarrhea.

The usual dosage of Cystadane in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams twice daily. In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments. Other drugs may interact with Cystadane. Tell your doctor all medications and supplements you use. During pregnancy, Cystadane should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Cystadane (betaine anhydrous) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cystadane in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using betaine and call your doctor at once if you have a serious side effect such as:

  • unusual headache, dizziness, neck pain or stiffness
  • memory problems;
  • changes in your mental state;
  • vision changes;
  • problems with speech, balance, or walking;
  • decreased consciousness; or
  • seizure (black-out or convulsions).

Less serious side effects may include:

  • nausea, upset stomach;
  • diarrhea;
  • unusual body odor; or
  • unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cystadane (Betaine Anhydrous) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cystadane Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, stomach upset, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent headache, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cystadane (Betaine Anhydrous)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cystadane FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Reactions in Clinical Studies

The most serious adverse reaction reported with Cystadane (betaine anhydrous) treatment is the development of hypermethioninemia and cerebral edema in patients with CBS Deficiency [see WARNINGS AND PRECAUTIONS].

The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Cystadane (betaine anhydrous) . Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey. Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported (Table 1):

Table 1: Number of Patients with Adverse Reactions to Cystadane (betaine anhydrous) by Physician Survey

Adverse Reactions Number of Patients
Nausea 2
Gastrointestinal distress 2
Diarrhea 1
“Bad taste” 1
“Caused odor” 1
Questionable psychological changes 1
“Aspirated the powder” 1

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Cystadane (betaine anhydrous) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with Cystadane (betaine anhydrous) , severe cerebral edema and hypermethioninemia have been reported within 2 weeks to 6 months of starting betaine therapy, with complete recovery after discontinuation of Cystadane (betaine anhydrous) . All patients who developed cerebral edema had homocystinuria due to CBS deficiency and had severe elevation in plasma methionine levels (range 1,000 to 3,000 μM). As cerebral edema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action.

The following adverse reactions have been reported in patients during postmarketing use of Cystadane (betaine anhydrous) : anorexia, agitation, depression, irritability, personality disorder, sleep disturbed, dental disorders, diarrhea, glossitis, nausea, stomach discomfort, vomiting, hair loss, hives, skin odor abnormalities, and urinary incontinence.

Read the entire FDA prescribing information for Cystadane (Betaine Anhydrous) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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