The following serious adverse reactions are described as follows and elsewhere in monograph: Acute Interstitial Nephritis; Clostridium difficile-Associated Diarrhea; Bone Fracture; Cutaneous and Systemic Lupus Erythematosus; Cyanocobalamin (Vitamin B-12) Deficiency; Hypomagnesemia. (See 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 were evaluated in 4548 adult patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 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 11. (See Table 11.)
Click on icon to see table/diagram/image
Adverse Reactions Resulting in Discontinuation: In controlled clinical studies, the most common adverse reaction leading to discontinuation from DEXILANT therapy 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 as follows 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 uncontrolled studiy 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 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 (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
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.
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.