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Cholbam

cholic acid
Used for Bile Acid Synthesis Disorder
Used for Bile Acid Synthesis Disorder

Cholbam (cholic acid) is approved for use to treat certain adults and children with rare genetic conditions that affect the liver called bile acid synthesis disorders and peroxisomal disorders. This medication belongs to a drug class called bile acids that work to help your body make more bile acid. Side effects aren't typically common, but can sometimes include diarrhea. This medication might raise your risk for worsening liver problems.

Reviewed by:
reviewer
Ashley Wong, PharmD
reviewer
Cydnee Ng, PharmD
Last reviewed on December 20, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageCostReferencesPricesMedicare
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What is Cholbam (cholic acid)?

What is Cholbam (cholic acid) used for?

How Cholbam (cholic acid) works

People with bile acid synthesis disorders and certain peroxisomal disorders can't make healthy bile acid. Bile acid normally helps the body break down and absorb nutrients, the liver to work properly, and get rid of waste from the body. Without enough healthy bile acid, toxic waste builds up in the body, which can lead to liver damage.

Cholbam (cholic acid) is a bile acid replacement medication. It's not completely clear how the medication works, but it's thought to help keep the right amount of healthy bile acids in your body. This might help your body absorb essential nutrients and lessen harm to the liver.

Are you looking for information on Ocaliva (obeticholic acid) or Kybella (deoxycholic acid) instead?

Drug Facts

Common BrandsCholbam
Drug ClassBile acid
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Cholbam (cholic acid)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Diarrhea (3%)

Other Side Effects

  • Acid reflux
  • Nausea
  • Stomach pain
  • Tiredness
  • Yellowing of your skin or eyes (jaundice)
  • Unusual growth on your skin
  • Weakness or numbness in your hands and feet
  • Growth on the lining of your intestine (polyp)
  • Urinary tract infection (UTI)

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Worsening liver problems: yellowing of the skin or eyes (jaundice), severe pain in the upper right side of your stomach, nausea, vomiting, dark urine, bleeding, bruising that occurs more easily than normal, tiredness

Source: DailyMed

pros-and-cons

Pros and cons of Cholbam (cholic acid)

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Pros

Only medication approved for rare genetic conditions that cause abnormal bile acid levels and liver problems

Safe to use in infants and children

Can open capsules and sprinkle contents on soft foods or milk for easy swallowing

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Cons

Might have to take twice a day

Requires frequent blood tests to check on your liver

Brand-name medication only

pharmacist-tips

Pharmacist tips for Cholbam (cholic acid)

pharmacist

  • Take Cholbam (cholic acid) with food. Swallow the capsules whole. Don't crush or chew the capsules.

    • If you have trouble swallowing pills or if you're giving Cholbam (cholic acid) to a child, you can open the capsule and mix the medication into soft food (e.g., applesauce, mashed potatoes), infant formula, or breast milk. This can help the medication taste better. After you carefully pour the medication over 1 or 2 tablespoons of food or liquid, stir for 30 seconds. The medication won't dissolve and it will look like fine sand. Take or give the mixture right away.

      • Make sure to get your regular blood work done on time while you're taking Cholbam (cholic acid). These blood tests help your provider make sure the medication isn't damaging your liver.

        faqs

        Frequently asked questions about Cholbam (cholic acid)

        Is Cholbam (cholic acid) the same as cyclobenzaprine?
        No, Cholbam (cholic acid) and cyclobenzaprine are two completely different medications. Cholbam (cholic acid) is a medication that helps treat adults and children with rare genetic conditions that can affect the liver called bile acid synthesis disorders and certain peroxisomal disorders. On the other hand, cyclobenzaprine is a muscle relaxant that helps relieve muscle discomfort and muscle spasms.
        When was Cholbam (cholic acid) first approved?
        Cholbam (cholic acid) was first approved by the FDA in March 2015. It's currently the only medication that can treat certain rare genetic conditions called bile acid synthesis disorders and peroxisomal disorders.
        Can I open Cholbam (cholic acid) capsules?
        Yes. For children or adults who can't swallow pills, you can open the Cholbam (cholic acid) capsule and mix the medication into soft foods (like applesauce or mashed potatoes), infant formula, or breast milk. Mixing the medication into food can help it taste better. Carefully follow the instructions to open the capsule and pour the contents over the food or liquid. Once it's mixed, you should take or give the medication right away. Speak with your provider or pharmacist if you have any questions about how to prepare Cholbam (cholic acid) after you open the capsules.
        How often will I need lab work done while I'm taking Cholbam (cholic acid)?
        Your provider will order blood tests every month for the first 3 months after you start taking Cholbam (cholic acid). You'll need blood work done every 3 months for the following 9 months and then every 6 months for the following 3 years. Afterwards, you'll get lab work done once per year. These blood tests will help your provider check your liver to make sure the medication is working properly and isn't harming your liver.
        Is it safe to take Cholbam (cholic acid) during pregnancy?
        It's not known whether Cholbam (cholic acid) is safe for you or your unborn baby. There haven't been any studies about using the medication during pregnancy in humans or animals. Speak with your provider if you're pregnant or thinking about getting pregnant to discuss the risks and benefits of taking Cholbam (cholic acid). Also tell your provider right away if you become pregnant during treatment. There's a surveillance program you can enroll in that will keep track of your health and your baby's health if exposed to the medication during pregnancy; call 1-844-202-6262 to enroll.
        Can I take antacids while I'm taking Cholbam (cholic acid)?
        Yes, but there are specific instructions that you should follow to take them together. Take Cholbam (cholic acid) at least 1 hour before or 4 to 6 hours after you take any antacids have aluminum in them (for example, Mylanta). Taking Cholbam (cholic acid) too close to these types of antacids can lower the amount of Cholbam (cholic acid) your body absorbs, which might make the medication work less well. Check with your pharmacist or provider if you're not sure whether your antacid medication contains aluminum.
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        What are the risks and warnings for Cholbam (cholic acid)?

        Cholbam (cholic acid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

        risk-warning

        Worsening liver problems

        • Risk factors: History of liver problems

          Some people had worsened liver problems during treatment with Cholbam (cholic acid). Tell your provider if you have any types of liver problems before you start taking this medication so your care team can follow up with you more closely. You'll need to get blood tests done often while you're taking Cholbam (cholic acid) so your provider can check on your liver.

          You'll need to stop Cholbam (cholic acid) if your lab results show signs of worsening liver problems or if you start to have worsening symptoms. Get medical help right away if you have yellowing of the skin or eyes (jaundice), dark urine, pain in the upper right side of your stomach, nausea, or vomiting because these can be signs of liver damage.

          dosage

          Cholbam (cholic acid) dosage forms

          Typical dosing for Cholbam (cholic acid)

          Your provider will calculate the dose based on your body weight. The typical dose is 10 mg/kg to 15 mg/kg of weight taken by mouth once per day. This dose can also be split into 2 equal doses throughout the day.

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          References

          Best studies we found

          Demczko, M., et al. (2022). Peroxisomal disorders. Merck Manual Consumer Version.

          Global Foundation for Peroxisomal Disorders. (n.d.). Peroxisomal disorders.

          Manchester Pharmaceuticals, LLC. (2023). Cholbam- colic acid capsule [package insert]. DailyMed.

          View All References (6)

          MedlinePlus. (2023). Vitamins.

          National Organization for Rare Disorders. (2020). Bile acid synthesis disorders.

          National Organization for Rare Disorders. (2020). Zellweger spectrum disorders.

          Shulpekova, Y., et al. (2022). The role of bile acids in the human body and in the development of diseases. Molecules.

          Tholey, D., et al. (2023). Cholestasis. Merck Manual Consumer Version.

          U.S. Food and Drug Administration. (2020). Drug trials snapshot: Cholbam (peroxisomal disorders).

          GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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