- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- What is Dexilant (dexlansoprazole) indicated for?
- What are the most common side effects of Dexilant (dexlansoprazole)?
- Can I continue to use brand name Dexilant?
- Does Dexilant have any cost saving programs?
- Dexilant Overview
How does this medication work? What will it do for me?
Dexlansoprazole belongs to the family of medications called proton pump inhibitors (PPIs). It is used to treat erosive esophagitis (acid-related damage to the tube that connects your mouth to your stomach), maintain the healing of erosive esophagitis, and to treat heartburn associated with gastroesophageal reflux disease (GERD). Dexlansoprazole works by reducing the amount of acid the stomach produces.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each opaque, blue and gray capsule with ‘TAP” and “30” imprinted on the capsule contains 30 mg of dexlansoprazole. Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, low-substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 8000, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate; capsule shell: black ferric oxide, carrageenan, FD&C Blue No. 2 Aluminum Lake, hypromellose, potassium chloride, and titanium dioxide.
Each opaque, blue capsule with “TAP” and “60” imprinted on the capsule contains 60 mg of dexlansoprazole. Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, low-substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 8000, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate; capsule shell: carrageenan, FD&C Blue No. 2 Aluminum Lake, hypromellose, potassium chloride, and titanium dioxide.
How should I use this medication?
For the treatment of erosive esophagitis, the usual dose of dexlansoprazole is 60 mg once daily for up to 8 weeks.
To maintain the healing of erosive esophagitis, the usual dose is 30 mg once daily for up to 6 months.
For heartburn associated with GERD, the usually dose is 30 mg once daily for 4 weeks.
Dexlansoprazole can be taken with or without food. It should be swallowed whole with lots of water. Alternatively, the contents of the capsule can be sprinkled on one tablespoon of applesauce and swallowed immediately. The granules should not be chewed.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Dexlansoprazole should not be taken by anyone who:
- is allergic to dexlansoprazole or to any of the ingredients of the medication
- is taking the medication rilpivirine
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- diarrhea (mild)
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- diarrhea (watery and severe; may also be bloody)
- symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- convulsion or seizure
- signs of a severe skin reaction (e.g., high fever; rash; skin peeling off; or painful blisters on the skin, mouth, or eyes)
- symptoms of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
April 4, 2013
Health Canada has issued new information concerning the use of Dexilant® (dexlansoprazole). To read the full report, visit Health Canada’s website at www.hc-sc.gc.ca.
Previous advisories on Dexilant® were issued on February 16, 2012 and on October 19, 2012.
To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Bone health: Studies suggest that the use of dexlansoprazole, like other PPIs, may be related to an increased risk of fractures, particularly for people who take this medication for a year or longer. The lowest dose of this medication to control the symptoms, taken for the shortest period of time, is less likely to cause these problems.
Diarrhea: When gastric acid is decreased, the number of bacteria normally in the digestive system increases. Occasionally, this can cause serious infection in the digestive tract. If you experience watery, foul-smelling bowel movements after starting to take dexlansoprazole, contact your doctor as soon as possible.
Fractures: Long-term use of proton-pump inhibitors has been associated with an increased risk for osteoporosis-related fracture of the hip, wrist, or spine. If you have osteoporosis or have risk factors for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver problems: People with liver problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Magnesium levels: In rare instances, dexlansoprazole may cause low magnesium levels in people who take this medication for a prolonged period of time. Low magnesium may occur after at least 3 months, but usually after a year of treatment. If you have low magnesium levels in your blood, you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Methotrexate interaction: Dexlansoprazole, like other medications in this group, may interact with methotrexate when the two medications are used at the same time. This combination may lead to higher than expected amounts of methotrexate in the body and can cause serious side effects, including kidney damage, irregular heartbeat, anemia, or infection. If you take dexlansoprazole and are also going to receive a dose of methotrexate, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Other stomach problems: Even if you experience improvement in acid-related symptoms, it is still possible to have serious underlying stomach problems such as stomach cancer. Talk to your doctor if you have other symptoms of stomach problems such as loss of appetite, nausea, vomiting, a bloated feeling after eating, changes in bowel habits, or unexplained weight loss or fatigue.
Vitamin B12: Long-term use of dexlansoprazole may lead to vitamin B12 deficiency. If you are a vegetarian or have low vitamin B12 levels, discuss with your doctor whether any special monitoring is required.
Pregnancy: This medication should not be taken during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if dexlansoprazole passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between dexlansoprazole and any of the following:
- amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- bisphosphonates (e.g., alendronate, etidronate)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- iron supplements
- multivitamins with iron, folate
- “statin” anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
- tyrosine kinase inhibitors (e.g., crizotinib, dasatinib, imatinib, nilotinib)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Dexilant
Heartburn, also known as acid reflux or gastroesophageal reflux disease (GERD), is a digestive disease in which stomach acid of bile irritates the food pipe lining.
These days, many heartburn medications are conveniently available over-the-counter. However, some of these medications still require a prescription from your doctor. Common treatments include medications like Nexium (esomeprazole), Protonix (pantoprazole) and Dexilant—which now has a generic.
On May 16th, 2017, the FDA approved the generic for Dexilant, dexlansoprazole, which can help you save at the pharmacy!
What is Dexilant (dexlansoprazole) indicated for?
Dexilant (dexlansoprazole) capsules are indicated for healing and maintenance of erosive esophagitis, heartburn relief, and treatment of symptomatic gastroesophageal reflux disease (GERD).
Dexlansoprazole will be available as a capsule in a strength of 60 mg. Brand name Dexilant is also available as a 30 mg capsule, but it has not been approved in a generic form yet.
Dexlansoprazole is unique in that it delivers 2 releases of medicine in one capsule. The first release occurs within an hour of taking dexlansoprazole and the second occurs 4 – 5 hours later.
What are the most common side effects of Dexilant (dexlansoprazole)?
The most common side effects associated with dexlansoprazole include diarrhea, nausea, stomach pain, vomiting, common cold and gas. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
Can I continue to use brand name Dexilant?
If you would like to continue taking brand name Dexilant, make sure your doctor hand writes “brand medically necessary” on your prescription. This means the pharmacy is not permitted to substitute and give you the generic product. If your doctor doesn’t indicate this on your prescription, you can also request it from your pharmacist before having your prescription filled.
Keep in mind that because the generic product is now available, your insurance company may not be willing to cover the cost of the more expensive brand medication. Be sure to check your prescription insurance company to find out if it is covered before taking a trip to the pharmacy.
Does Dexilant have any cost saving programs?
Yes! The manufacturer of Dexilant, Takeda Pharmaceuticals, has an instant savings card available for commercially insured patients. Eligible patients can pay no more than $20 for their dexilant capsule prescription and refills.
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Interstitial Nephritis
- Clostridium difficile-Associated Diarrhea
- Bone Fracture
- Cutaneous and Systemic Lupus Erythematosus
- Cyanocobalamin (Vitamin B12) Deficiency
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of DEXILANT capsules were evaluated in 4548 adult patients in controlled and single-arm clinical trials, including 863 patients treated for at least six months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on DEXILANT 30 mg capsules, 2218 patients on DEXILANT 60 mg capsules, and 1363 patients on lansoprazole 30 mg once daily.
Common Adverse Reactions
The most common adverse reactions (≥2%) that occurred at a higher incidence for DEXILANT capsules than placebo in the controlled studies are presented in Table 2.
Table 2. Common Adverse Reactions in Controlled Studies in Adults
Adverse Reactions Resulting in Discontinuation
In controlled clinical studies, the most common adverse reaction leading to discontinuation from DEXILANT capsules was diarrhea (0.7%).
Less Common Adverse Reactions
Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system:
Blood and Lymphatic System Disorders: anemia, lymphadenopathy
Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia
Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo
Endocrine Disorders: goiter
Eye Disorders: eye irritation, eye swelling
Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett’s esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage, retching
General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia
Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly
Immune System Disorders: hypersensitivity
Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection
Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn
Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase
Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia
Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia
Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia
Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes
Renal and Urinary Disorders: dysuria, micturition urgency
Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder
Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, sore throat
Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritus, rash, skin lesion, urticaria
Vascular Disorders: deep vein thrombosis, hot flush, hypertension
Additional adverse reactions that were reported in a long-term single-arm trial and were considered related to DEXILANT by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, bursitis, central obesity, cholecystitis acute, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gout, herpes zoster, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, rectal tenesmus, restless legs syndrome, somnolence, tonsillitis.
The safety of DEXILANT capsules were evaluated in controlled and single-arm clinical trials including 166 pediatric patients,12 to 17 years of age for the treatment of symptomatic non-erosive GERD, healing of EE, maintenance of healed EE and relief of heartburn .
The adverse reaction profile was similar to that of adults. The most common adverse reactions that occurred in ≥5% of patients were headache, abdominal pain, diarrhea, nasopharyngitis and oropharyngeal pain.
Other Adverse Reactions
See the full prescribing information for lansoprazole for other adverse reactions not observed with DEXILANT.
The following adverse reactions have been identified during post-approval of DEXILANT. 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.
Blood and Lymphatic System Disorders: autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura
Ear and Labyrinth Disorders: deafness
Eye Disorders: blurred vision
Gastrointestinal Disorders: oral edema, pancreatitis
General Disorders and Administration Site Conditions: facial edema
Hepatobiliary Disorders: drug-induced hepatitis
Immune System Disorders: anaphylactic shock (requiring emergency intervention), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
Infections and Infestations: Clostridium difficile-associated diarrhea
Metabolism and Nutrition Disorders: hypomagnesemia, hyponatremia
Musculoskeletal System Disorders: bone fracture
Nervous System Disorders: cerebrovascular accident, transient ischemic attack
Renal and Urinary Disorders: acute renal failure
Respiratory, Thoracic and Mediastinal Disorders: pharyngeal edema, throat tightness
Skin and Subcutaneous Tissue Disorders: generalized rash, leukocytoclastic vasculitis
Read the entire FDA prescribing information for Dexilant (Dexlansoprazole Capsules and Tablets)
Dexilant is a proton pump inhibitor, a kind of drug that reduces stomach acid and treats symptoms of gastroesophageal reflux disease. Dexilant used to be called Kapidex and is made by Japanese pharmaceutical company Takeda. Dexilant has recently been found to have possible connections to some very serious side effects when used over the long-term. These range from pneumonia to chronic kidney disease, and may cause people to suffer from devastating illnesses, or even to die from them. If you have been harmed by Dexilant, now may be the right time to file a lawsuit against Takeda.
What is Dexilant?
Dexilant is a prescription drug developed and manufactured by Takeda Pharmaceuticals, a Japanese-based company. It belongs to the class of drugs called proton pump inhibitors, or PPIs, and is used to treat symptoms of GERD, gastroesophageal reflux disease, among other similar uses. The generic name of the drug is dexlansoprazole and it was first created in the 2000s and approved by the U.S. Food and Drug Administration (FDA) in 2009.
The FDA also approved a name change for the drug. It was originally called Kapidex, but this was similar to the names of two other medications: Kadian and Casodex. Takeda got permission from the FDA to start marketing dexlansoprazole as Dexilant in the spring of 2010. The name change was triggered by reports of errors in dispensing the medication because of confusion with the others. The three drugs are not similar and are used to treat different things.
Uses for Dexilant
Dexilant is used to treat the heartburn associated with GERD. This is a condition that is characterized by stomach acid flowing backwards and up the esophagus. This causes heartburn, but also serious damage to the esophagus. Using Dexilant to treat the heartburn gives the esophagus a chance to heal and it prevents even more damage. This damage is called esophageal erosion. Dexilant works in these ways by inhibiting the proton pumps in the stomach, which reduces the amount of acid that is made.
The most common side effects that patients report experiencing when taking Dexilant include abdominal pains, upper respiratory tract infections, vomiting, diarrhea, nausea, and flatulence. These are not considered to be serious side effects in most patients, but they should be reported to a doctor if they become severe or do not lessen over time.
There are also some uncommon, but potential side effects of Dexilant. Anyone who experiences these should seek immediate emergency medical attention. The serious symptoms include a rash and hives, itchy skin, trouble breathing or swallowing, a fast heartbeat, an irregular heartbeat, lightheadedness, dizziness, shaking, severe diarrhea, a fever, excessive tiredness, and muscle spasms.
Long-Term Side Effects
GERD is a chronic condition, which means that some people use Dexilant and other PPIs over the long term. Doing so has long been considered safe and low-risk, but with more research, long-term consequences of using these drugs are emerging and are troubling. Dexilant inhibits the formation and release of stomach acid, but that acid is necessary for digesting food and as a first line defense against infectious agents.
Of the many consequences of using Dexilant for a long time, one may be pneumonia. Pneumonia is an infection in the lungs. During the night, when a person is laying down, stomach contents may come up the esophagus and enter the trachea, which leads to the lungs. This happens in most people, but healthy people are able to combat any potential infection before it starts. In people on PPIs, however, the stomach is less acidic and more likely to contain bacterial cells that cause pneumonia. This means that people using PPIs are at a greater risk of developing the infection.
Another potential issue is another type of bacterium that causes severe diarrhea. It is called Clostridium difficile and infection caused by this bacterium causes a kind of diarrhea that can be life-threatening. Usually a person gets infected by it through ingestion in food. With the lower stomach acidity in people on Dexilant, the bacteria have a greater chance of surviving and causing an infection that can become severe.
Connections have also been found between PPIs like Dexilant and vitamin and mineral deficiencies. These drugs seem to affect how a person absorbs calcium, which can lead to weak bones, osteoporosis, and bone fractures. The drugs may also impact vitamin B12 levels and cause a deficiency that can lead to a type of anemia.
Chronic Kidney Disease
One of the most troubling of all potential risks of using Dexilant is the potential for kidney damage and chronic kidney disease. A couple of recent studies found this connection and has suggested that it explains why the number of cases of kidney disease has risen recently. Dexilant and similar drugs are widely used by many people.
One of the studies looked at over 10,000 people from another study to look for connections between PPI use and chronic kidney disease. The connection was clearly seen, although it wasn’t possible to be sure that Dexilant or other PPIs caused the kidney disease. The link between the two, however, was significant. Chronic kidney disease is a serious condition. If left untreated it will ultimately lead to the failure of the kidneys and death. If an underlying cause can be found the disease may be cured, but often it is a condition someone must live with forever.
Lawsuits over Dexilant are likely to be filed in the near future. The information about potential serious side effects from long-term use of the drug is just now coming to light thanks to research studies. Patients who have suffered, and possibly even died, from pneumonia, diarrhea, or kidney disease may be able to make a case against manufacturers of PPIs like Takeda, the maker of Dexilant. Living with a chronic condition like kidney disease is expensive, disruptive, and can be painful and even debilitating. It can be difficult to live a normal life when living with something like chronic kidney disease.
Because research is only just now finding out how serious some of the side effects of Dexilant are, lawsuits have not yet been filed. There is still time, if you believe you were harmed by long-term use of this drug, to make your case and seek justice and compensation. Further investigations may make the connection between Dexilant and serious illnesses clearer, but may also uncover information about what Takeda knew and didn’t know about these consequences. If the company can be found to have known about the risks, the cases against it will be strong and people like you may be able to recover monetary damages.