Sun Pharma introduced Fexuclue 40 mg in India in April 2025 after fexuprazan hydrochloride tablets 40 mg were approved by India’s Central Drugs Standard Control Organisation for erosive esophagitis. Sun Pharma obtained the Indian rights to manufacture and commercialise the medicine from Daewoong Pharmaceutical, the company that developed fexuprazan.

Fexuclue Tablet 40 mg is an acid-suppressing prescription medicine containing fexuprazan. It belongs to a newer group of medicines known as potassium-competitive acid blockers, usually abbreviated as P-CABs. Doctors may prescribe it to adults with erosive esophagitis, a form of gastroesophageal reflux disease in which repeated exposure to stomach contents inflames and damages the lining of the esophagus.

When acidic stomach contents repeatedly flow back into the esophagus, they can cause heartburn, sour-tasting regurgitation and irritation. Erosive esophagitis involves visible breaks in the esophageal lining, usually assessed during an endoscopy. By reducing gastric acid, Fexuclue creates a more favorable environment for this lining to heal and may ease acid-related symptoms.

Fexuclue is not an antacid. Antacids neutralize some acid already in the stomach for a limited period. Fexuprazan acts at the acid-producing proton pump and is intended to provide sustained acid control when taken as prescribed.

Fexuclue 40 mg is approved in India for the treatment of erosive esophagitis in adults. Erosive esophagitis is commonly caused by gastroesophageal reflux, but a clinician may need to confirm the diagnosis and assess its severity before prescribing treatment. Symptoms can include heartburn, acid regurgitation, discomfort behind the breastbone, painful swallowing or difficulty swallowing. Some people have limited symptoms despite visible esophageal injury, while similar symptoms can also arise from other conditions.

The medicine’s goals are to suppress gastric acid, support healing of erosions and help control acid-related symptoms during the prescribed treatment period. In Sun Pharma’s announced Phase 3 study in Indian adults, healing was confirmed by endoscopy and more than 95% of patients achieved healing by eight weeks. A separate randomized Phase 3 study conducted in Korea found fexuprazan 40 mg non-inferior to esomeprazole 40 mg for cumulative healing at eight weeks. Individual results still vary, and clinical trial outcomes cannot predict a particular patient’s response.

Fexuclue is not a self-treatment for every episode of acidity

Do not assume that recurring chest pain, indigestion, nausea or swallowing difficulty is simply acid reflux. Heart disease, ulcers, infections, medication-related injury and other disorders can produce overlapping symptoms. Fexuclue may reduce acid-related discomfort and could mask warning signs, so professional evaluation is important, especially when symptoms are new, severe, persistent or unusual.

Specialized parietal cells in the stomach produce hydrochloric acid. A key final step in this process is controlled by the gastric hydrogen-potassium adenosine triphosphatase enzyme, commonly written as H+/K+-ATPase and often called the proton pump. Potassium ions participate in the pump’s operation.

Fexuprazan binds competitively and reversibly at the potassium-binding area of this proton pump. By interfering with potassium-dependent pump activity, it reduces the release of hydrogen ions into the stomach and therefore suppresses gastric acid secretion. Unlike conventional proton pump inhibitors, fexuprazan can inhibit the pump directly without first requiring acid activation.

Sun Pharma describes a fast onset, stable acid suppression and an approximately nine-hour half-life. Food did not meaningfully change exposure or acid-control measurements in the cited product information, supporting administration with or without food. Healing still takes time, so continue the prescribed course unless your doctor tells you to stop or a serious reaction occurs.

When prescribed for a suitable adult patient with erosive esophagitis, Fexuclue offers several practical and therapeutic features:

• Targeted acid suppression: Fexuprazan acts at the final pathway responsible for gastric acid secretion.
• Supports healing: Consistent acid control gives esophageal erosions a better opportunity to recover.
• May improve acid-related symptoms: Heartburn and regurgitation may ease as acid exposure decreases and healing progresses.
• Convenient administration: Available prescribing information permits use with or without food.
• Clinical evidence: Comparative studies have supported fexuprazan’s effectiveness for healing erosive esophagitis.

These features are not a guarantee of cure. A doctor should decide whether Fexuclue is suitable after considering the diagnosis, other medicines, pregnancy status and overall health.

Take Fexuclue exactly as directed by your doctor and follow the instructions printed on your supplied pack. The available prescribing information for adults with erosive esophagitis describes 40 mg taken orally once daily for four weeks. If the esophagitis has not healed or symptoms persist, a doctor may continue treatment for a further four weeks. Do not extend the course yourself.

• Take the tablet at approximately the same time each day to support consistent use.
• It may be taken with or without food.
• Swallow it with water. Follow the local product label regarding splitting; do not crush or chew it unless a pharmacist confirms that this is acceptable for the supplied formulation.
• Do not take more tablets, take them more frequently or continue longer than prescribed.
• Do not share your prescription with another person, even if their symptoms seem similar.

If you miss a dose

Follow the patient leaflet or your prescriber’s instructions. In general, take a missed dose when you remember unless it is nearly time for the next scheduled dose. If the next dose is close, skip the missed dose and return to the usual schedule. Never take two doses together to compensate without medical advice.

If you take too much

Contact a doctor, pharmacist, poison information service or emergency department promptly, even if you currently feel well. Bring the medicine strip or package so healthcare staff can identify the product and amount. The available information reports no specific antidote; management is based on monitoring and supportive care as clinically required.

Like all medicines, Fexuclue can cause side effects, although not everyone experiences them. Events reported in clinical trials of fexuprazan 40 mg included indigestion, diarrhea, nausea, abdominal discomfort, headache, skin redness and back pain. Less frequently reported events included dizziness, altered taste, itching, facial swelling, muscle pain, chest discomfort and runny nose. An event observed during a trial is not always proven to have been caused by the medicine.

Many gastrointestinal effects are mild, but persistent or severe symptoms deserve medical advice. Watery or prolonged diarrhea, especially with fever, abdominal pain, dehydration or blood, should be assessed promptly because strong acid suppression may slightly increase susceptibility to certain gastrointestinal infections.

Get urgent medical help if you develop:

• swelling of the face, lips, tongue or throat;
• difficulty breathing or swallowing;
• a widespread or rapidly worsening rash, blistering or faintness;
• severe or persistent chest pain;
• black stools, vomiting blood or material that looks like coffee grounds;
• severe weakness, confusion, irregular heartbeat or seizures.

This list is not exhaustive. Read the leaflet supplied with the medicine and tell your doctor about any new or troubling symptom. Do not drive or operate machinery if you feel dizzy or otherwise impaired.

Tell your doctor about all current illnesses, allergies, test results and medicines before starting Fexuclue. Extra caution or a different treatment plan may be needed in some situations.

Warning symptoms and possible malignancy

Acid suppression can improve symptoms even when a more serious disorder is present, potentially delaying diagnosis. Seek medical evaluation if you have unintended weight loss, recurrent vomiting, difficulty or pain when swallowing, vomiting blood, black stools, anemia, a new stomach ulcer or symptoms that continue despite treatment. A clinician may need to exclude malignancy or another cause before or during therapy.

Liver, kidney and older patients

Safety and efficacy have not been established in patients with hepatic or renal impairment in the cited prescribing information. Tell your doctor if you have liver or kidney disease. Older adults may be more likely to have reduced organ function or multiple interacting medicines and should use Fexuclue carefully under professional supervision.

Long-term acid suppression

Any longer-term use should be medically reviewed. Prolonged acid-suppressing therapy has been associated with concerns such as low magnesium and osteoporosis-related fractures. Patients using digoxin, diuretics or medicines that lower magnesium may require monitoring.

Allergies and lactose

Do not take Fexuclue if you are allergic to fexuprazan or any ingredient in the supplied tablet. Some Fexuclue formulations contain lactose and Yellow No. 4 (tartrazine). The referenced product information contraindicates use in people with certain rare hereditary conditions involving galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption and advises caution with tartrazine allergy. Check your local pack because excipients can differ.

Children and adolescents

Safety and effectiveness have not been established in children or adolescents. Do not give this medicine to a child unless a qualified specialist specifically directs it.

Give your doctor and pharmacist a complete list of prescription drugs, over-the-counter medicines, vitamins, herbal products and supplements. Do not start, stop or change a medicine because of information on this page.

By raising gastric pH, fexuprazan can change the absorption of oral medicines whose bioavailability depends on an acidic stomach. The referenced prescribing information lists medicines containing atazanavir, nelfinavir or rilpivirine as contraindicated because reduced absorption may compromise antiviral treatment. Other pH-dependent medicines may also require assessment.

Fexuprazan is metabolized mainly by the CYP3A4 enzyme, with lesser involvement from CYP2B6, CYP2C19 and CYP2D6. In a studied regimen, co-administration with clarithromycin produced only a small change in fexuprazan exposure that was not considered clinically significant. This finding should not be generalized to every CYP3A4 inhibitor, inducer or combination. Your prescriber should review possible interactions individually.

Tell your clinician if you use digoxin, diuretics or another medicine associated with low magnesium, especially if prolonged acid suppression is planned. Also mention antifungals, cancer medicines, immunosuppressants and other therapies that may depend on gastric pH or have a narrow therapeutic range. A pharmacist can check the most current interaction database for your exact medicines and doses.

Pregnancy

The referenced Fexuclue prescribing information contraindicates use during pregnancy because adequate clinical trial data in pregnant women are unavailable. Tell your doctor immediately if you are pregnant, planning a pregnancy or think you may be pregnant. Do not use the medicine based only on internet advice.

Breastfeeding

It is not known whether fexuprazan passes into human breast milk; transfer into milk has been reported in animal studies. The referenced product information advises discontinuing breastfeeding if treatment is used. A healthcare professional should help weigh the importance of treatment against the benefits of breastfeeding and discuss suitable alternatives.

Alcohol

No simple interaction statement makes alcohol automatically safe. Alcohol can trigger or worsen reflux, irritate the upper gastrointestinal tract and interfere with healing habits. Ask your doctor whether you should avoid it during treatment; limiting or avoiding alcohol is often sensible when reflux symptoms are active.

Driving and machinery

Dizziness has been reported. Until you know how Fexuclue affects you, use caution with driving, riding, machinery or work requiring full alertness. Do not perform these activities if you feel dizzy, faint or visually impaired.

Medicine works best as part of a plan tailored to the causes and pattern of your reflux. The following measures may help some people, but not every trigger affects everyone:

• Eat smaller portions and avoid very large or heavy meals late in the evening.
• Allow about two to three hours between the final meal and lying down, if your doctor agrees.
• Identify personal food or drink triggers instead of unnecessarily restricting everything.
• For night symptoms, ask about safely elevating the head end of the bed.
• Work toward a healthy weight when excess abdominal weight contributes to reflux.
• Avoid tobacco and limit alcohol.

Lifestyle changes do not replace prescribed treatment for documented erosive injury. Arrange follow-up if symptoms persist, return quickly after the course, or include difficulty swallowing, bleeding or weight loss.

• Store Fexuclue according to the temperature and moisture instructions printed on the original pack.
• Keep the tablets in their original strip or container until it is time to take a dose.
• Protect the medicine from excessive heat, moisture and direct sunlight.
• Keep it out of the sight and reach of children and pets.
• Do not use tablets after the printed expiry date or if the packaging is damaged or the tablet appearance has changed.
• Do not dispose of unused medicine in wastewater or household rubbish unless local guidance allows it. Ask a pharmacist about safe disposal.

Buy prescription medicines only through a lawful, reputable pharmacy that requires the documentation applicable in your country. Check the product name, strength, manufacturer, batch number, expiry date and seal when it arrives. Contact the dispensing pharmacy before use if anything appears incorrect.