Eticholic 5mg Tablet (Obeticholic Acid): Complete Medicine Guide
When to Call Your Doctor IMMEDIATELY
- Yellowing of the skin or eyes (jaundice)
- Confusion, disorientation, or difficulty concentrating
- Swelling of the abdomen (ascites)
- Vomiting blood or black, tarry stools
- Severe itching that interferes with sleep or daily activities
- Dark urine or pale-colored stools
- Sudden severe abdominal pain, especially in the upper right side
- Signs of allergic reaction such as swelling of the face, lips, tongue, or throat, or difficulty breathing
If experiencing severe symptoms, call emergency services immediately.
What is fxr 5 tablet used for?
This medicine contains obeticholic acid 5 mg, an FXR agonist used to treat primary biliary cholangitis in adults who do not respond adequately to ursodeoxycholic acid. It works by reducing bile acid production and improving bile flow, which helps lower liver enzyme levels and slow liver damage. It is taken orally once daily, usually starting at 5 mg, and may be increased to 10 mg after 3 months if needed. Regular liver function monitoring is essential.
- Generic Name: Obeticholic acid (5mg)
- Manufacturer: Dr Reddy's Laboratories Ltd
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 fxr 5 tablet के बारे में (Hindi Summary)
उपयोग: यह दवा ओबेटिकोलिक एसिड 5 मिलीग्राम की गोली है, जिसे मुख्य रूप से प्राइमरी बिलियरी कोलैंगाइटिस (पीबीसी) नामक लिवर की बीमारी के इलाज के लिए इस्तेमाल किया जाता है। यह उन वयस्कों के लिए दी जाती है जिनका यूर्सोडीऑक्सीकोलिक एसिड से पूरा फायदा नहीं होता या जो उसे सहन नहीं कर पाते। यह दवा लिवर में पित्त एसिड के उत्पादन को कम करती है और पित्त के प्रवाह को सुधारती है, जिससे लिवर की सूजन और नुकसान कम होता है। यह दवा लिवर एंजाइम के स्तर को कम करने में मदद करती है और बीमारी की प्रगति को धीमा कर सकती है। यह दवा लिवर विशेषज्ञ की देखरेख में ही लेनी चाहिए और नियमित रूप से लिवर फंक्शन टेस्ट कराते रहना चाहिए।
साइड इफेक्ट्स: इस दवा के सबसे आम दुष्प्रभावों में खुजली, थकान, पेट दर्द, जी मिचलाना, चक्कर आना, कब्ज, जोड़ों में दर्द और हाथ-पैरों में सूजन शामिल हैं। कुछ लोगों को गले में खराश, बुखार या अस्वस्थता महसूस हो सकती है। एक गंभीर लेकिन दुर्लभ दुष्प्रभाव लिवर की कार्यप्रणाली का बिगड़ना है, खासकर उन लोगों में जिन्हें पहले से उन्नत लिवर रोग है। अगर आपको आंखों या त्वचा का पीला पड़ना, गहरे रंग का पेशाब, भ्रम, या पेट में सूजन महसूस हो, तो तुरंत डॉक्टर से संपर्क करें। इस दवा से कोलेस्ट्रॉल का स्तर भी बढ़ सकता है, इसलिए समय-समय पर जांच कराते रहें।
सुरक्षा सलाह: इस दवा को अपने लिवर विशेषज्ञ के बताए अनुसार ही लें और अपनी मर्जी से डोज न बदलें। गोली को पानी के साथ पूरा निगलें, इसे चबाएं या तोड़ें नहीं। इसे हर दिन एक ही समय पर लें। अगर आप कोई अन्य दवा, हर्बल उत्पाद या सप्लीमेंट ले रहे हैं, तो डॉक्टर को बताएं, क्योंकि इससे दवाओं में परस्पर क्रिया हो सकती है। नियमित रूप से लिवर फंक्शन टेस्ट, कोलेस्ट्रॉल की जांच और खुजली का मूल्यांकन कराते रहें। गर्भावस्था, गर्भधारण की योजना या स्तनपान के दौरान डॉक्टर से सलाह लें। इस दवा के सेवन के दौरान शराब बिल्कुल न पिएं। अगर आपको गंभीर खुजली, आंखों या त्वचा का पीलापन, भ्रम या पेट में सूजन हो, तो तुरंत डॉक्टर से मिलें। दवा को कमरे के तापमान पर, मूल डिब्बे में, नमी और धूप से दूर रखें।
💊 fxr 5 tablet Uses & Benefits
[{"condition":"Primary biliary cholangitis (PBC) with inadequate response to ursodeoxycholic acid","description":"This medicine is added to ursodeoxycholic acid therapy in adults with primary biliary cholangitis who have not achieved an adequate reduction in alkaline phosphatase or who still have raised liver enzymes.","evidence":"Well-established"},{"condition":"Primary biliary cholangitis (PBC) in patients who cannot tolerate ursodeoxycholic acid","description":"This medicine may be used as monotherapy in adults with primary biliary cholangitis who are unable to take ursodeoxycholic acid because of side effects or intolerance.","evidence":"Well-established"}]
Off-label uses: [{"condition":"Non-alcoholic steatohepatitis (NASH)","description":"This medicine has been studied in non-alcoholic steatohepatitis, but it is not approved for this use and is not recommended outside clinical trials.","evidence":"Limited"},{"condition":"Primary sclerosing cholangitis (PSC)","description":"Some small studies have explored this medicine in primary sclerosing cholangitis, but evidence is insufficient and it is not an approved indication.","evidence":"Limited"}]
Primary treatment for: Primary biliary cholangitis (PBC)
Also treats: Chronic liver disease with cholestasis, Non-alcoholic steatohepatitis (investigational)
📋 Drug Information
| Generic Name(s) | Obeticholic acid (5mg) |
| Brand Name | fxr 5 tablet |
| Manufacturer | Dr Reddy's Laboratories Ltd |
| Packaging / Form | Varies by brand (Allopathy) |
| Therapeutic Class | GASTRO INTESTINAL |
| Action Class | |
| Route of Administration | Oral |
| Storage | Store this medicine at room temperature between 15°C and 30°C (59°F to 86°F). Keep it in the original container, tightly closed, away from moisture and direct sunlight. Do not store it in the bathroom. Keep out of reach of children and pets. |
| Shelf Life | The shelf life of this medicine is not established from the available information. Do not use beyond the expiry date printed on the pack. |
| WHO Guideline | Not established from the available information. Guidelines from professional liver societies may recommend this medicine for primary biliary cholangitis in patients with inadequate response to ursodeoxycholic acid. Consult your doctor for guideline-based recommendations. |
| ICMR Guideline | Not established from the available information. ICMR guidelines for primary biliary cholangitis may include this medicine as a second-line option. Consult your doctor for specific recommendations. |
👨⚕️ Doctor's Practical Tips
Evidence-based practical advice from experienced clinicians
🔍 Is This Medicine Right for Your Symptom?
Educational reference. Always consult a doctor for diagnosis.
🔬 How This Medicine Works (Pharmacology)
Pharmacokinetics
How It Works
This medicine works by activating the farnesoid X receptor (FXR), a nuclear receptor that is highly expressed in the liver and intestine. Activation of FXR reduces the production of bile acids in the liver and decreases their absorption from the intestine, which lowers the amount of toxic bile acids reaching the liver. It also improves bile flow and reduces liver inflammation and fibrosis. Through these actions, this medicine helps lower liver enzymes such as alkaline phosphatase and slows the progression of liver damage in primary biliary cholangitis.
Mechanism Steps
💡 How to Take fxr 5 tablet
Strength: Immediate-release tablet containing 5 mg of obeticholic acid.
Dosage Information
| Adult Dosage | The usual starting dose of this medicine for adults with primary biliary cholangitis is 5 mg taken by mouth once daily. The dose may be increased to 10 mg once daily after 3 months if needed and if tolerated, based on liver enzyme response and side effects. For patients with moderate or severe hepatic impairment, the starting dose and titration schedule may be different. Dose must be individualized by a qualified clinician based on indication, age, weight, renal and hepatic function, and response to treatment. Do not change the dose without consulting your doctor. |
| Pediatric Dosage | Pediatric dosing is not established from available information. Consult a pediatrician. |
| Elderly Dosage | No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may have reduced liver or kidney function and may be more sensitive to side effects. Dose should be individualized by a qualified clinician based on overall health, liver function, and other medicines being taken. |
| Renal Impairment | No dose adjustment is recommended for patients with mild to moderate renal impairment. The safety and efficacy of this medicine in patients with severe renal impairment or end-stage renal disease have not been established. Use with caution and under specialist supervision in such patients. |
| Hepatic Impairment | For patients with moderate hepatic impairment (Child-Pugh B), the recommended starting dose is 5 mg once weekly, and the dose may be increased to 5 mg twice weekly based on response and tolerability. For patients with severe hepatic impairment (Child-Pugh C), this medicine is contraindicated or should be used with extreme caution under specialist supervision. Dose must be individualized by a qualified clinician based on liver function tests and clinical status. |
| Maximum Daily Dose | The maximum recommended daily dose of this medicine is 10 mg once daily for adults with normal liver function. For patients with moderate hepatic impairment, the maximum dose is 5 mg twice weekly. Do not exceed the dose prescribed by your doctor. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of fxr 5 tablet
✅ Common Side Effects
🚨 Serious Side Effects
⚠️ Rare Side Effects
Consult your doctor if you experience any unusual symptoms.
🔬 Drug Interactions
| Drug | Severity | Effect |
|---|---|---|
| Cholestyramine | Major | |
| Warfarin | Major | |
| Theophylline | Major | |
| Atorvastatin | Moderate | |
| Amlodipine | Moderate | |
| Antacids | Minor | |
| St. John's wort | Minor |
🚨 Major Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol, colesevelam)
- Warfarin and other vitamin K antagonists
- CYP1A2 substrates (e.g., theophylline, caffeine)
⚡ Moderate Interactions
- Statins (e.g., atorvastatin, simvastatin)
- Antihypertensive medicines
🍷 Alcohol Interaction
Alcohol should be avoided completely while taking this medicine. Alcohol can worsen liver damage and may increase the risk of liver-related side effects. If you have a history of alcohol use, discuss it with your doctor before starting this medicine.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Complete biliary obstruction","Decompensated cirrhosis (e.g., ascites, encephalopathy, variceal bleeding) or a history of decompensation events","Known hypersensitivity to obeticholic acid or any component of this medicine","Use in patients with a history of liver transplant or those awaiting liver transplant is not recommended","Severe hepatic impairment (Child-Pugh C) without specialist supervision"]
⚠️ Warnings & Precautions
["This medicine should only be prescribed by a liver specialist experienced in managing primary biliary cholangitis.","Liver function should be monitored closely, especially during the first year of treatment and after any dose adjustment.","Patients with advanced liver disease are at higher risk of liver decompensation; this medicine is contraindicated in such patients.","Itching is a common side effect and may require dose reduction or additional treatment. Report severe itching to your doctor.","This medicine may increase cholesterol levels. Lipid levels should be monitored and managed appropriately.","Women of childbearing potential should use effective contraception during treatment.","Avoid alcohol consumption while taking this medicine.","Do not take this medicine with bile acid sequestrants at the same time; separate doses by at least 4 hours.","Inform your doctor about all other medicines, supplements, and herbal products you are taking.","Keep all follow-up appointments and laboratory tests as scheduled."]
🤱 Lactation Safety
It is not known whether this medicine passes into breast milk. Because of the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue breastfeeding or to discontinue the medicine, taking into account the importance of the medicine to the mother. Consult your doctor before breastfeeding.
💊 Overdose Management
There is limited information on overdose with this medicine. In case of suspected overdose, contact your doctor or a poison control center immediately. Treatment should be supportive and symptomatic. Monitor liver function and vital signs closely. There is no specific antidote. If overdose is recent, activated charcoal may be considered if appropriate. Do not attempt to induce vomiting unless instructed by a healthcare professional.
⏰ Missed Dose
If you miss a dose of this medicine, take it as soon as you remember if it is less than half the dosing interval away. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed dose. If you are unsure, contact your doctor or pharmacist for advice.
Additional Safety Advice
Take this medicine exactly as prescribed by your liver specialist, and never change the dose on your own. Swallow the tablet whole with water, with or without food, at the same time each day. Do not start or stop any other medicine, herbal product, or supplement without asking your doctor, because some medicines can interact with this medicine. Keep all your follow-up appointments and get your liver function tests, cholesterol levels, and itching assessment done as advised. Tell your doctor if you are pregnant, planning pregnancy, or breastfeeding, because the safety of this medicine in these situations is not fully established. Avoid alcohol completely while taking this medicine, as alcohol can worsen liver disease. If you develop severe itching, yellowing of the skin or eyes, confusion, or swelling of the abdomen, contact your doctor immediately. Store the tablets in their original container at room temperature, away from moisture and direct sunlight, and keep them out of reach of children.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients may be more sensitive to the side effects of this medicine, especially dizziness and fatigue. They may also have reduced liver or kidney function, which can affect how the medicine is processed. Dose should be individualized by a qualified clinician based on overall health and liver function. Regular monitoring is particularly important in this age group.
🤰 Pregnancy Planning (TTC)
If you are planning to become pregnant, discuss with your doctor before starting or continuing this medicine. The safety of this medicine during pregnancy is not established. Effective contraception should be used while taking this medicine. If you become pregnant while taking this medicine, inform your doctor immediately.
🏥 Post-Surgery Considerations
If you are undergoing surgery, inform your surgeon and anesthesiologist that you are taking this medicine. There is limited information on the use of this medicine around surgery. Your doctor may recommend temporary discontinuation or dose adjustment based on your liver function and the type of surgery. Do not stop the medicine without medical advice.
🦷 Dental Procedures
Inform your dentist that you are taking this medicine before any dental procedure. There are no specific contraindications for dental work, but your dentist may need to know about your liver condition and any other medicines you are taking. Maintain good oral hygiene to prevent infections.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
Moderate exercise is generally safe while taking this medicine, but you should avoid strenuous activities if you feel tired or dizzy. If you have advanced liver disease or experience swelling, consult your doctor before starting any new exercise routine. Listen to your body and rest when needed.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause dizziness or tiredness in some people. If you experience these effects, avoid driving or operating heavy machinery until you know how the medicine affects you. Most people can continue their normal daily activities, but you should discuss any specific work-related concerns with your doctor. Regular monitoring and follow-up may require time off work for appointments.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your doctor. Your doctor may consider stopping the medicine if you develop serious side effects such as liver decompensation, severe itching that cannot be managed, or if the medicine is not providing sufficient benefit. If you experience any red-flag symptoms, seek immediate medical attention. Always discuss with your doctor before making any changes to your treatment.
📅 Long-Term Use Effects
Long-term use of this medicine may help slow the progression of primary biliary cholangitis and improve liver enzyme levels. However, it can also cause persistent itching, increased cholesterol levels, and in rare cases, liver decompensation. Regular monitoring of liver function, lipid profile, and itching severity is essential. Your doctor will assess the benefit-risk balance periodically and may adjust the dose or stop treatment if needed. Do not stop the medicine on your own.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
First-line treatment for primary biliary cholangitis. This medicine is often used as add-on therapy when response to ursodeoxycholic acid is inadequate.
Evidence: Well-establishedMay be used off-label as add-on therapy in patients with inadequate response to ursodeoxycholic acid.
Evidence: LimitedA healthy diet, avoiding alcohol, and regular exercise can support liver health and overall well-being.
Evidence: Well-established💉 Vaccination Considerations
💉 If You're Getting Vaccinated
There are no specific vaccine interactions reported with this medicine. However, patients with chronic liver disease should discuss vaccination against hepatitis A and hepatitis B with their doctor, as these infections can worsen liver disease. Follow your doctor's recommendations for routine vaccinations.
📦 Storage Guide
✅ DO
Store at room temperature between 15°C and 30°C (59°F to 86°F).
❌ DON'T
Do not refrigerate or freeze unless specified.
✅ DO
Keep in the original container, tightly closed.
❌ DON'T
Do not transfer to unmarked containers.
✅ DO
Keep away from direct sunlight and moisture.
❌ DON'T
Do not store in the bathroom cabinet.
✅ DO
Keep out of reach of children and pets.
❌ DON'T
Do not use after the expiry date.
✈️ Traveling with This Medicine
When traveling, carry this medicine in its original packaging with the prescription label clearly visible. Bring a copy of your prescription and a letter from your doctor explaining your medical condition and the need for this medicine, especially for international travel. Keep the medicine in your carry-on luggage to avoid loss or temperature extremes. Store it at room temperature, away from direct sunlight and moisture. If you are crossing time zones, continue taking your dose at the same time each day as much as possible, but consult your doctor for specific advice if you are unsure. Check customs regulations for carrying prescription medicines in your destination country.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: This medicine may take several weeks to months to show its full effect on liver enzyme levels. Your doctor will monitor your progress with regular blood tests.
A: Yes, this medicine can be taken with or without food. Taking it with food may help if you experience stomach upset.
A: If you miss a dose, take it as soon as you remember if it is less than half the dosing interval away. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double dose.
A: No, do not stop taking this medicine without consulting your doctor. Stopping suddenly may cause your liver enzymes to rise again and worsen your condition.
A: The safety of this medicine during pregnancy is not established. Inform your doctor if you are pregnant, planning pregnancy, or breastfeeding. Use effective contraception while taking this medicine.
A: Seek immediate medical attention if you notice yellowing of the skin or eyes, confusion, swelling of the abdomen, vomiting blood, or severe itching. These may be signs of liver decompensation or other serious problems.
🤔 Common Patient Concerns
🔄 Substitutes for fxr 5 tablet
View AllAlternative brands with exact same active ingredient:
-
obiholic 5mg tabletMankind Pharma Ltd ₹150.00 57.3% CHEAPER
-
filoca 5 tabletFourrts India Laboratories Pvt Ltd ₹168.75 52% CHEAPER
-
obstela 5mg tabletSun Pharmaceutical Industries Ltd ₹168.75 52% CHEAPER
-
ocafib 5mg tabletCadila Healthcare Limited ₹168.75 52% CHEAPER
-
obetas 5mg tabletTas Med India Pvt Ltd ₹178.13 49.3% CHEAPER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: This medicine can cure primary biliary cholangitis.
Fact: This medicine does not cure primary biliary cholangitis. It helps manage the condition by improving liver enzyme levels and slowing liver damage, but it is not a cure. - Myth: I can stop taking this medicine once my liver enzymes are normal.
Fact: You should not stop taking this medicine without consulting your doctor. Stopping suddenly may cause your liver enzymes to rise again and worsen your condition. - Myth: This medicine is safe for everyone with liver disease.
Fact: This medicine is not safe for everyone. It is contraindicated in patients with complete biliary obstruction or decompensated cirrhosis. It should only be used under specialist supervision. - Myth: Itching is not a serious side effect and can be ignored.
Fact: Itching is a common side effect and can sometimes be severe. It should be reported to your doctor, as it may require dose adjustment or additional treatment.
🔄 Alternative Options
Generic Alternatives
- Obeticholic acid 5 mg tablet (generic)
Brand Alternatives
- Eticholic 5mg Tablet