The road to understanding ursodeoxycholic acid stretches back over a century. Originally extracted from bear bile in traditional East Asian medicine, its use was all about treating jaundice and digestive complaints. Decades passed before Western science dug into the chemical structure, eventually recognizing its potential far beyond folk remedies. In the 1950s, pharmacologists managed to isolate and identify the compound. Enter the 1970s, and researchers began clinical trials, showing benefits for patients with gallstones and certain liver diseases. The pharmaceutical industry quickly embraced synthetic routes, distilling out the bear from the bile and making it with yeast and chemical synthesis instead. Today, ursodeoxycholic acid is recognized as a go-to therapy for primary biliary cholangitis, intrahepatic cholestasis of pregnancy, and more—years of medical history condensed into a bottled tablet on the pharmacist’s shelf.
Walk into any pharmacy with a prescription for primary biliary cholangitis, and you’ll see ursodeoxycholic acid tablets in 250 mg or 500 mg strengths, often labeled as UDCA or ursodiol. These aren’t just branded pills; they have generic versions, reflecting the widespread, off-patent nature of the drug. Some manufacturers also produce capsules and oral suspensions. Patients with rare genetic liver issues have access to this same molecule, which speaks to the broad acceptance in hepatology. Drug instructions mention the necessity of consistent daily use and monitoring of liver function, reminding us that even long-standing medicines demand respect and vigilance in administration.
On the lab bench, ursodeoxycholic acid appears as a white, crystalline powder. It has a faint, almost bitter taste and doesn’t let off any strong odor. The CAS number is 128-13-2. The molecular formula, C24H40O4, tells us it belongs to the steroid family—related to many cholesterol and bile acids in the body. Chemists note a melting point around 202°C, with the substance poorly soluble in water but better dissolved in alcohol and acetone. These characteristics shape its absorption in the gut and its formulation into tablets and suspensions. Polymorphism has rarely shown up in commercial preparations but gets attention in academic circles, especially for those studying improved dissolution or bioavailability.
Pharmaceutical-grade ursodeoxycholic acid packs a minimum purity of 98%, with manufacturers required to demonstrate negligible levels of impurities like chenodeoxycholic acid and related bile acids. The United States Pharmacopeia (USP) and European Pharmacopoeia (EP) jointly set standards for particle size, moisture content, and assay methods, which means every batch lands in a tightly defined chemical window before shipping. Labeling on finished products highlights storage instructions—typically below 25°C and out of direct sunlight. Patient inserts detail possible side effects (stool changes, diarrhea, rarely severe allergic reactions) and interactions with other cholesterol-lowering drugs. Those details matter, especially for prescribers in multidisciplinary teams treating complex liver patients.
The old bear bile route faded away due to cost and ethics. Today, most suppliers use a two-part chemical process that starts with cholic acid, a plentiful bile acid extracted from bovine sources or recreated by microbial fermentation. Enzymatic oxidation and reduction steps shift the stereochemistry, slowly converting cholic acid or chenodeoxycholic acid to the targeted 7-beta isomer—ursodeoxycholic acid. These steps depend on microbial biotransformation, where certain bacteria excel at the required conversion. Chemical purification follows, removing isomers or unreacted starting material by solvent extraction, crystallization, and chromatography. Each change in preparation improves not just yield but purity, meeting tight regulatory standards demanded by authorities worldwide. The complexity in synthesis reflects the intricate dance between chemistry, biology, and regulatory oversight that so many modern pharmaceuticals depend on.
Ursodeoxycholic acid offers a canvas for chemical tweaks, mainly at its hydroxyl groups or the steroid framework. Researchers have tried to produce prodrugs aiming for better bioavailability or targeted delivery. Esterification at the 3- or 7-hydroxyl positions changes solubility, sometimes allowing for sustained release formulations or different therapeutic applications. Oxidative modifications replicate metabolites observed in bile, with some resulting in compounds with unique immunomodulatory effects. Analytical chemists see these reactions as a way to understand both the metabolism and pharmacokinetics of bile acids in the human body. From a pharmaceutical point of view, every modification spawns fresh safety and efficacy evaluations, not to mention attention from drug regulators.
Pharmacists and doctors use several names for this molecule. Ursodiol stands as its international nonproprietary name (INN), while the United States Adopted Name (USAN) stays the same. Trade names include Actigall, Urso, Urso Forte, and Destolit. You’ll spot synonyms like 3α,7β-dihydroxy-5β-cholan-24-oic acid in scientific articles, and “ursodeoxycholicum acidum” on academic ingredient lists. A couple of Asian markets call it “Ursosan,” often in the context of over-the-counter availability for gallstones and liver complaints. Even with the spread of names, the core remains the purified, 7-beta hydroxylated bile acid recognized the world over.
Hospital pharmacists and drug makers take ursodeoxycholic acid safety standards seriously. Occupational exposure to the powder calls for gloves, face masks, and adequate dust extraction, since inhaling even “safe” bioactive compounds can cause health issues. For patients, routine blood draws check liver enzymes and bilirubin, catching rare toxicities early. International guidelines from agencies like the FDA, EMA, and WHO spell out maximum daily exposures, pediatric warnings, contraindications for patients with calcified gallstones or active peptic ulcer disease, and essential precautions for pregnancy and lactation. Drug manufacturers conduct ongoing monitoring for adverse effects, reporting cases of hypersensitivity, cholestatic jaundice, or paradoxical liver dysfunction. Such vigilance pairs well with regular regulatory inspections—the only way to keep medicines safe as they reach millions of users.
Doctors prescribe ursodeoxycholic acid most often for chronic cholestatic liver diseases, especially primary biliary cholangitis and primary sclerosing cholangitis, both diseases marked by slowly progressing bile duct destruction and serious risk of cirrhosis. The medicine’s job is to lower the concentration of toxic bile acids, protect liver cells, and delay transplant or liver failure. For patients with cholesterol gallstones unwilling or unable to have surgery, ursodiol helps dissolve stones over months—sometimes avoiding an operation completely. Specialists treating cystic fibrosis or certain pediatric liver diseases also recommend ursodeoxycholic acid, particularly to improve bile flow. Occasionally, oncologists involve it in clinical trials targeting colorectal and liver cancer risk, following intriguing epidemiological hints. Veterinary medicine even turns to it for dogs and cats with hepatic lipidosis or gallstones. Over-the-counter versions in Asia address broad, less regulated uses, though these lack rigorous supporting evidence compared to prescription therapy in regulated markets.
Pharmaceutical research into ursodeoxycholic acid ebbs and flows, but drug development teams keep pressing for new uses and improved formulations. The challenge is not only refining oral absorption but expanding the therapeutic reach. A steady flow of studies in journals like "Hepatology" or "Journal of Gastroenterology" document its use in rare pediatric liver disorders or autoimmune conditions outside the classic cholestatic diseases. Some scientists debate its utility in metabolic syndrome or non-alcoholic fatty liver disease, given promising early-phase data. Drug delivery experts tinker with nanoparticle suspensions and prodrug constructs, all hunting for ways to outdo the classic pill’s effectiveness. The pipeline includes combined therapies, pairing ursodiol with new antifibrotic agents or immune modulators that target the deeper pathways underpinning liver and bile duct scarring. Collaborative trials help answer whether ursodeoxycholic acid can drive better patient outcomes when traditional therapies fail.
Toxicity studies on ursodeoxycholic acid give it a favorable profile when compared to many other hepatology drugs. Animal studies indicate a high threshold for acute toxicity, with doses hundreds of times higher than those used in humans showing only mild gastrointestinal disturbance. Human case reports flag rare allergic reactions, diarrhea, and paradoxical elevation in liver enzymes as main safety concerns. Prolonged use in infants and children carries risks, especially if underlying metabolic or genetic errors exist, since off-label dosing increases the chance of error. Researchers also look into potential drug-drug interactions, as bile acid metabolism crosses over with statins, cyclosporine, and immunosuppressants. Ongoing pharmacovigilance, rooted in real-world data collection from liver clinics and prescription registries, gives clinicians early warning signals if safety trends start to shift. That diligence becomes more important as off-label use grows or as combination therapy becomes routine in clinical care.
Looking ahead, ursodeoxycholic acid stands poised for both stability and reinvention in liver therapy. Traditional indications remain solid anchors, but innovation pushes into broader metabolic and oncological territory. Clinical trials update old assumptions, asking whether new combinations can slow the march to liver failure in ways never imagined fifty years ago. Regulatory agencies urge stricter monitoring and longitudinal studies, aware of subtle shifts in real-world safety data. The pharmaceutical industry considers cost-pressure, patent cliffs, and demand for generics, prompting creative synthesis techniques and delivery strategies. The race to make this medicine accessible, affordable, and consistently beneficial—especially in developing countries—draws on lessons from history and research. As new generations of patients and clinicians engage with ursodeoxycholic acid, the medicine’s story keeps unfolding, shaped by the science, safety vigilance, and real-world care that anchor modern pharmacotherapy.
People often see long, unfamiliar names on prescription bottles and tune out. Ursodeoxycholic acid—often called UDCA—belongs to that group. Digging into what this medicine does for real people and how it can turn around certain health problems feels more useful than memorizing its chemical structure.
Cholestasis stirs up problems inside the liver. It clogs the natural flow of bile, which cells rely on to get rid of waste. I’ve seen adults with primary biliary cholangitis (PBC), an autoimmune liver disease, struggle with itchiness, fatigue, and confusion that don’t always show up in blood tests. The liver works hard, but even the best machine can break down and let toxic bile acids build up.
Doctors often reach for UDCA because it changes the mix of chemicals in bile, making it less toxic. The medicine helps bile flow better. Over time, liver tests improve. Scars on the liver form slower. Quality of life can climb. According to the American Liver Foundation, about 80% of people with PBC respond to UDCA—something no vitamin can promise. My time in clinics tells me this outcome matters, especially for patients who picture their condition as a slow march without good options.
Every year, people dread the news that a gallstone is causing pain. Surgery comes with risks and time off work. UDCA offers a shot for those who can’t, or won’t, head into the operating room. It shrinks cholesterol stones—the most common type—by dissolving them over several months, which keeps pain and complications at bay. This approach does not fit everyone; stones sometimes return, and it works best with small stones, according to research from Cochrane reviews. The chance to avoid the operating table remains valuable for plenty of people unwilling to take surgical risks.
Kids who deal with genetic liver conditions, such as cystic fibrosis-related liver disease, often have limited choices. UDCA offers a lifeline, helping their bodies process bile better. Some families feel a sense of relief with even modest success, as it can mean less pain and fewer hospital visits.
No drug solves every problem, and UDCA does not fix advanced liver failure or all forms of hepatitis. It carries few side effects, mostly mild stomach troubles. Still, trust in UDCA often comes from experience—patients see real differences in itchiness, energy levels, and lab results.
A medicine earns trust over years, not weeks. Doctors read studies from respected journals like Hepatology or The New England Journal of Medicine confirming its track record. Health agencies in the United States and Europe approve its use, proving it cleared plenty of hurdles.
A medicine like UDCA shows that not all progress happens in tech or gadgets. Evidence pushes doctors to use it where it works—primarily in cholestatic liver diseases and cholesterol gallstones. For those left out—such as people who don’t respond to UDCA—researchers keep searching. Newer medicines like obeticholic acid promise help for those who need alternatives.
Anyone who wonders about this drug deserves to know: it’s more than a tough name. It’s a reliable option, proven by real-world use, and a sign that medical progress doesn’t always require a laboratory breakthrough.
Doctors often prescribe ursodeoxycholic acid for liver problems—bile stones, primary biliary cholangitis, or even certain types of hepatitis. This medicine comes from bile acids naturally found in the body. I’ve seen how a simple tablet can offer real relief for those struggling with liver and gallbladder issues, especially when options get limited. The route of taking this medicine can make all the difference in the results you feel.
I remember a patient who started taking ursodeoxycholic acid every morning without eating, thinking this would “make it work faster.” Pretty quickly, they came back complaining of stomach pain. That’s because the gut doesn’t always appreciate an empty-stomach tablet—especially those tied to bile flow. With this medicine, swallowing the tablet after a meal tends to limit stomach upset. The liver works better with a little food support on board, which helps the drug reach the places it needs to go.
Doctors prescribe the dose based on body weight. Many folks take it in two or three divided doses each day. Trying to cram it all into one gulp at breakfast or dinner can raise the risk of side effects and uneven absorption. Spreading out the dose creates a steadier level in the blood, and the liver gets a more consistent nudge to do its job. Missing tablets isn’t rare, but taking two doses at once doesn’t fix things—skipping ahead to the next scheduled time is usually safer.
Following the routine can be tough, especially when pills pile up or you’re feeling tired from liver problems. What I’ve learned: keeping the bottle in a handy spot, maybe next to your toothbrush or coffee, goes a long way. Tracking doses with a phone reminder—or a good old-fashioned calendar—also helps people avoid missed doses.
Sticking with the treatment makes a difference; stopping early can cause old symptoms to return and new complications to pop up. Ursodeoxycholic acid isn’t a quick fix. Some folks feel better in a month or two. For others, it takes six months—sometimes longer. Patience and regular check-ins with the liver doc are part of the deal. Getting blood work helps your provider catch problems like changes in liver enzymes, so it’s smart not to skip follow-up visits.
Most people handle this medicine just fine, but sometimes there’s diarrhea or mild stomach pain. I always encourage folks to keep a symptom journal; if anything unusual comes up, bring it up at the next appointment. Bad side effects—itching, yellowing skin, or serious stomach pain—call for a quick chat with your doctor.
Mixing medicines can cause problems. Tell your healthcare provider about everything you take, including health store supplements. Some drugs, especially ones that bind bile acids or affect liver metabolism, mess with how this medicine works.
A medicine like ursodeoxycholic acid doesn’t work in a vacuum. Watching your diet, following medical advice, and steering clear of alcohol give your liver a better chance at recovery. Regular doses, smart timing, and honest discussions with your healthcare team turn a simple pill into a cornerstone of liver health. It’s not always easy, but with solid habits, people can see real improvement and avoid complications down the road.
Doctors prescribe Ursodeoxycholic Acid (UDCA) for liver problems like primary biliary cholangitis and sometimes to dissolve certain gallstones. After years of working with patients dealing with liver disease, I’ve seen UDCA help many reclaim their energy and improve blood test results. It doesn’t act like magic, though. Drugs like this always leave a mark, so a closer look at side effects makes a difference for anyone considering or currently using it.
People using UDCA will often notice changes in their gut. Diarrhea tops the list for a lot of patients. In clinics, I’ve seen folks adjust their day around the unpredictable bathroom runs that come with this medication, especially early on. Soft stools or even mild abdominal discomfort show up often too. Not everybody faces the same level of discomfort, but these changes tend to set in within the first weeks. One study found that about one in ten folks will see a real change in their digestive routine.
UDCA sometimes brings on nausea, less often than diarrhea but still enough that patients mention it. Some will describe feeling queasy after taking their dose or struggle to eat a full meal. Bloating and flatulence can pop up, which adds to the discomfort, especially for anyone already trying to gain weight or keep food down. These symptoms tend to fade over time, though some people can’t shake them no matter how they tweak their dose or what time of day they take it.
The liver issues themselves often make people itch, but UDCA sometimes makes this sensation a little worse. Rarely, people break out with a rash. I encourage my patients to bring any new skin changes to the clinic’s attention, as sometimes a new rash can signal an allergy or something more serious going on under the surface. Research so far shows this side effect doesn’t hit most users, but even one case should prompt a quick conversation with a healthcare provider.
Every so often, someone will develop elevated liver enzymes or signs of worsening liver function after starting UDCA. Other hepatic problems can crop up, and these need careful monitoring—regular bloodwork helps catch most issues early. In all the charts I’ve reviewed, this pops up much less than the usual diarrhea or stomach pain, but it stays in the back of every doctor’s mind. Using tools like patient portals and follow-up calls to track symptoms can help spot trouble sooner.
Mood doesn’t always get the attention it deserves. A handful of patients have noted fatigue, headaches, or just feeling “off” mentally. While these aren’t top complaints, they matter. Chronic illness already wears people down, and adding a new medication can tip the balance. Clear and ongoing communication between patients and providers helps here—a simple check-in makes a difference, often catching these less visible side effects before they snowball.
Doctors can sometimes adjust the dose to help with stomach symptoms. Splitting the total into two or three smaller doses and pairing them with meals makes a real difference for some people. Over-the-counter remedies, like fiber supplements, sometimes ease diarrhea, and probiotics may help the gut settle down. If symptoms don’t settle after a few weeks, it makes sense to revisit the treatment plan. No one needs to soldier through miserable days without support—patients and care teams working together can often find a comfortable middle ground.
Pregnancy can bring joy, discomfort, and sometimes health scares that stretch a family’s peace of mind. Some women experience severe itching, yellowing of the skin, or dark urine—signs that point to cholestasis of pregnancy. Ursodeoxycholic acid (UDCA) often pops up in these conversations with medical staff. It’s a bile acid, refined from natural bile, and doctors use it to reduce bile acid build-up that happens with liver-related pregnancy conditions.
I remember a close friend in her third trimester struggling with relentless itching and little rest. Her OB-GYN drew blood and gave her terms that sounded new and terrifying. Intrahepatic cholestasis of pregnancy put her at risk, and after careful deliberation, her team prescribed her UDCA—not without discussing possible risks and benefits.
A lot of studies have centered on whether UDCA really helps the pregnant parent and the developing baby. Trusted bodies, like the Royal College of Obstetricians and Gynaecologists, point out that UDCA often brings quick relief from itching and lowers bile acid levels. For pregnancies complicated by cholestasis, lower bile acids mean less stress placed on both the fetus and mother, reducing the chance of bad outcomes like preterm labor or stillbirth.
Doctors aren’t handing out UDCA at random. They pay attention to the stage of pregnancy, the severity of the disease, and results from blood work. Large reviews cover hundreds of pregnant patients, yet medical experts always add a note of caution: UDCA isn’t a miracle cure or free from scrutiny. Some data question if it truly prevents all poor outcomes, but most point to real benefits in symptom relief. That said, no medicine should slide through unchecked—what works for one person brings risk for another.
Nursing presents another question. After delivery, many mothers hope to continue treatment for persistent liver disease. The research on UDCA entering breastmilk and reaching the baby is slim, but what we do know offers some reassurance. Only tiny amounts pass into milk, and so far, reports of harm in breastfed babies don’t exist in the major medical literature.
Health authorities such as the American Academy of Pediatrics rate UDCA as probably safe for breastfeeding. Doctors often weigh the benefits for the mother’s health against any trace risk. If a mother skips needed medication, her health can dip quickly and hurt her ability to care for a newborn. Every call involves real discussion—not just for safety, but also for mental health and a mother’s right to informed choice.
Every pregnancy writes its own story. I’ve learned that nothing replaces open, expert-guided decision-making. UDCA offers relief for many, but real peace of mind comes from talking through lab values, keeping close tabs on symptoms, and checking in often with a trusted health team.
Anyone facing liver trouble during pregnancy or breastfeeding wants answers, not empty promises. UDCA isn’t a fix for everything, but thousands of doctors find its use justified for real problems faced by their patients. Paying attention to individual health needs, checking guidance from major medical organizations, and using fresh research keep families and babies safer.
Most folks want a straight answer about how long UDCA takes to help. It rarely acts fast. For cholestatic liver problems, changes start to show up in lab results after three to six months, but real life improvements sometimes take up to a year or longer. For dissolving gallstones, six months is common, and treatments occasionally last beyond a year. All this waiting can feel endless, but progress—slow as it comes—builds up through steady effort, open conversation, and not giving up even when changes seem invisible.
People facing a new diagnosis don’t only need a prescription; they also need information that makes sense in everyday life. Doctors, nurses, and pharmacists all have a role in steering those on UDCA through the marathon rather than a sprint. Patience, honesty, and small goals along the way help everyone stay the course and get the outcome they deserve.
| Names | |
| Preferred IUPAC name | (3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid |
| Other names |
Ursodiol
UDCA 3α,7β-Dihydroxy-5β-cholan-24-oic acid |
| Pronunciation | /ˌɜːr.səʊ.diːˌɒk.sɪˈkə.lɪk ˈæs.ɪd/ |
| Preferred IUPAC name | (3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid |
| Other names |
Ursodiol
UDCA 3α,7β-Dihydroxy-5β-cholanic acid |
| Pronunciation | /ˌɜːr.səˌdiː.ˌɒk.sɪˈkə.lɪk ˈæs.ɪd/ |
| Identifiers | |
| CAS Number | 128-13-2 |
| Beilstein Reference | 1364701 |
| ChEBI | CHEBI:9647 |
| ChEMBL | CHEMBL1405 |
| ChemSpider | 204103 |
| DrugBank | DB01586 |
| ECHA InfoCard | euclid string: 100.018.420 |
| EC Number | 5β-cholanic acid-3α,7β-diol |
| Gmelin Reference | 107339 |
| KEGG | C02528 |
| MeSH | D017073 |
| PubChem CID | 4933 |
| RTECS number | YQ0160000 |
| UNII | UXQ3YNB0BM |
| UN number | Not regulated |
| CAS Number | 128-13-2 |
| Beilstein Reference | 3440867 |
| ChEBI | CHEBI:9647 |
| ChEMBL | CHEMBL1405 |
| ChemSpider | 9546 |
| DrugBank | DB01586 |
| ECHA InfoCard | 100.019.385 |
| EC Number | 5.6.1.13 |
| Gmelin Reference | 80989 |
| KEGG | C02528 |
| MeSH | D004203 |
| PubChem CID | 4933 |
| RTECS number | YQ3030000 |
| UNII | UXA9O2I8PR |
| UN number | Not assigned |
| Properties | |
| Chemical formula | C24H40O4 |
| Molar mass | 392.569 g/mol |
| Appearance | White or almost white, crystalline powder |
| Odor | Odorless |
| Density | 1.37 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 2.1 |
| Vapor pressure | 6.38E-19 mmHg |
| Acidity (pKa) | 6.25 |
| Basicity (pKb) | 14.86 |
| Magnetic susceptibility (χ) | -102.0e-6 cm³/mol |
| Refractive index (nD) | 1.613 |
| Viscosity | Viscous liquid |
| Dipole moment | 2.26 D |
| Chemical formula | C24H40O4 |
| Molar mass | 392.57 g/mol |
| Appearance | White or almost white, crystalline powder |
| Odor | Odorless |
| Density | 1.5 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 2.5 |
| Vapor pressure | 7.42E-18 mmHg at 25°C |
| Acidity (pKa) | 6.25 |
| Basicity (pKb) | 12.31 |
| Magnetic susceptibility (χ) | -7.3×10⁻⁶ |
| Refractive index (nD) | 1.613 |
| Viscosity | Viscous liquid |
| Dipole moment | 3.0493 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 695.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | −1.13 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -7900 kJ/mol |
| Std molar entropy (S⦵298) | 759.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -993.6 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -7706 kJ/mol |
| Pharmacology | |
| ATC code | A05AA02 |
| ATC code | A05AA02 |
| Hazards | |
| Main hazards | May cause gastrointestinal disturbances, allergic reactions, and rarely, severe liver toxicity |
| GHS labelling | GHS07, GHS08 |
| Pictograms | Keep out of reach of children; Read the package leaflet before use |
| Signal word | No signal word |
| Hazard statements | Non-hazardous according to Regulation (EC) No. 1272/2008. |
| Precautionary statements | Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Use only as directed by your physician. Store at room temperature, away from moisture and heat. |
| NFPA 704 (fire diamond) | NFPA 704: 1-1-0 |
| Flash point | > 430.1 °C |
| Autoignition temperature | > 438°C |
| Lethal dose or concentration | LD50 (rat, oral): >5,000 mg/kg |
| LD50 (median dose) | LD50 (median dose): Mouse oral LD50 = 7,400 mg/kg |
| NIOSH | Not Listed |
| PEL (Permissible) | Not established |
| REL (Recommended) | 300 mg daily in 2–3 divided doses |
| IDLH (Immediate danger) | Not listed |
| Main hazards | May cause gastrointestinal disturbances, allergic reactions, and rarely severe liver injury. |
| GHS labelling | GHS07, GHS08 |
| Pictograms | keep out of reach of children, read the package leaflet before use, prescription only medicine |
| Signal word | Warning |
| Hazard statements | No hazard statements. |
| Precautionary statements | Keep out of reach of children. Use with caution in patients with liver or biliary tract disorders. Consult your doctor if pregnant or breastfeeding. Do not exceed the recommended dose. Store below 30°C and protect from light and moisture. |
| NFPA 704 (fire diamond) | NFPA 704: 1-1-0 |
| Flash point | > 337.7 °C |
| Autoignition temperature | 680°C |
| Lethal dose or concentration | LD50 (mouse, oral): 5210 mg/kg |
| LD50 (median dose) | Ursodeoxycholic acid LD50 (median dose) is "UDCA LD50 (oral, rat) >5000 mg/kg |
| NIOSH | Not Listed |
| PEL (Permissible) | Not established |
| REL (Recommended) | 300 mg daily in 2–3 divided doses |
| Related compounds | |
| Related compounds |
Chenodeoxycholic acid
Deoxycholic acid Cholic acid Lithocholic acid |
| Related compounds |
Chenodeoxycholic acid
Deoxycholic acid Cholic acid Lithocholic acid |
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