Dexilant

What Is Dexilant?

Dexilant (dexlansoprazole) is a proton pump inhibitor (PPI) used to treat certain stomach and esophagus problems (such as acid reflux). It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough.

What Are Side Effects of Dexilant?

Common side effects of Dexilant include:

• diarrhea,
• nausea,
• vomiting,
• stomach pain,
• gas,
• stuffy nose,
• sneezing, or
• other cold symptoms

Dosage for Dexilant?

Dexilant is available as capsules in doses of 30 mg and 60 mg for adult use.

What Drugs, Substances, or Supplements Interact with Dexilant?

Dexilant may interact with the HIV medication atazanavir, ampicillin esters, digoxin, iron salts, ketoconazole, warfarin, tacrolimus, or clopidogrel. Tell your doctor all medications you are taking.

Dexilant During Pregnancy and Breastfeeding

During pregnancy, Dexilant should be used only when prescribed. It is unknown if this drug passes into breast milk. Similar drugs pass into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.

Additional Information

Our Dexilant (dexlansoprazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Dexilant SoluTab (dexlansoprazole) delayed-release orally disintegrating tablet is a proton pump inhibitor (PPI) indicated in adults for maintaining healing of erosive esophagitis (EE) and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). Common side effects of Dexilant SoluTab include:

• diarrhea
• abdominal pain
• nausea
• upper respiratory tract infection
• vomiting, and
• gas

The recommended dosage of Dexilant SoluTab is 30 mg once daily for up to 6 months for maintenance of healed EE, and 30 mg once daily for 4 weeks to treat symptomatic non-erosive GERD. Dexilant SoluTab may interact with antiretroviral drugs, warfarin, methotrexate, digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenoloate mofetil, ketoconazole/itraconazole, tacrolimus, St. John's Wort, rifampin, ritonavir, voriconazole, and alcohol. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before taking Dexilant SoluTab. It is unknown if Dexilant SoluTab will affect a fetus. It is unknown if Dexilant SoluTab passes into breast milk. Consult your doctor before breastfeeding.

Our Dexilant (dexlansoprazole) delayed-release capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Dexilant Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• a seizure (convulsions);
• sudden pain or trouble moving your hip, wrist, or back;
• kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking dexlansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use dexlansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• nausea, vomiting, stomach pain, gas;
• diarrhea;
• headache;
• mouth pain, sore throat; or
• stuffy nose, sinus pain, or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dexilant (Dexlansoprazole Capsules and Tablets)

 

Dexilant Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Bone Fracture [see WARNINGS AND PRECAUTIONS]
• Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
• Cyanocobalamin (Vitamin B12) Deficiency [see WARNINGS AND PRECAUTIONS]
• Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
• Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

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.

Adults

The safety of DEXILANT was 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, 2218 patients on DEXILANT 60 mg, 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 than placebo in the controlled studies are presented in Table 2.

Table 2: Common Adverse Reactions in Controlled Studies in Adults

Adverse Reaction	Placebo (N=896) %	DEXILANT 30 mg (N=455) %	DEXILANT 60 mg (N=2218) %	DEXILANT Total (N=2621) %	Lansoprazole 30 mg (N=1363) %
Diarrhea	2.9	5.1	4.7	4.8	3.2
Abdominal Pain	3.5	3.5	4.0	4.0	2.6
Nausea	2.6	3.3	2.8	2.9	1.8
Upper Respiratory Tract Infection	0.8	2.9	1.7	1.9	0.8
Vomiting	0.8	2.2	1.4	1.6	1.1
Flatulence	0.6	2.6	1.4	1.6	1.2

Adverse Reactions Resulting In Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from DEXILANT 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.

Pediatrics

The safety of DEXILANT was 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 [see Clinical Studies].

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.

Postmarketing Experience

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, fundic gland polyps

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)