Kapidex Side Effects

Generic Name: dexlansoprazole

Please note - some side effects for Kapidex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Kapidex - for the Consumer

Kapidex Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kapidex Delayed-Release Capsules:

Diarrhea; gas; nausea; stomach pain; upper respiratory tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Kapidex Delayed-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; calf pain, swelling, or tenderness; chest pain, numbness of an arm or leg, sudden severe vomiting or dizziness, or vision changes; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain, tenderness, swelling, or warmth; red, swollen, blistered, or peeling skin; seizures; shortness of breath; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Kapidex Side Effects - for the Professional

Kapidex

Clinical Trials Experience

The safety of Kapidex was evaluated in 4548 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 Kapidex 30 mg, 2218 patients on Kapidex 60 mg, and 1363 patients on lansoprazole 30 mg once daily.

As 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.

Most Commonly Reported Adverse Reactions

The most common adverse reactions (≥2%) that occurred at a higher incidence for Kapidex than placebo in the controlled studies are presented in Table 2.

Table 2: Incidence of Treatment-Emergent Adverse Reactions in Controlled Studies

	Placebo	Kapidex 30 mg	Kapidex 60 mg	Kapidex Total	Lansoprazole 30 mg
Adverse Reaction	(N=896) %	(N=455) %	(N=2218) %	(N=2621) %	(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 Kapidex therapy was diarrhea (0.7%).

Other 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, nausea and vomiting, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage

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, dyspnoea, hiccups, hyperventilation, respiratory tract congestion, sore throat

Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritis, rash, skin lesion, urticaria

Vascular Disorders: deep vein thrombosis, hot flush, hypertension

Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to Kapidex by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, bursitis, central obesity, cholecystitis acute, decreased hemoglobin, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gastrointestinal pain, gout, herpes zoster, hyperglycemia, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, oral soft tissue disorder, polydipsia, polyuria, rectal tenesmus, restless legs syndrome, somnolence, thrombocythemia, tonsillitis.

Other adverse reactions not observed with Kapidex, but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4.7% to 5.1%), abdominal pain (3.5% to 4%), nausea (2.8% to 3.3%), vomiting (1.4% to 2.2%), and flatulence (1.4% to 2.6%). Other gastrointestinal side effects reported in clinical studies at an incidence of less than 2% were abnormal feces, anal discomfort, Barrett's esophagus, bezoar, abnormal bowel sounds, breath odor, microscopic colitis, 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, oral paresthesia, and rectal hemorrhage.

The most common adverse reaction leading to discontinuation of dexlansoprazole in clinical studies was diarrhea (0.7%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (1.7% to 2.9%). Other respiratory side effects reported in clinical studies at an incidence of less than 2% were aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, and sore throat.

Musculoskeletal

Musculoskeletal side effects reported in clinical studies at an incidence of less than 2% were arthralgia, arthritis, muscle cramps, musculoskeletal pain, bursitis, and myalgia. Postmarketing studies have shown an increased risk of bone fracture.

Metabolic

Metabolic side effects reported in clinical studies at an incidence of less than 2% were appetite changes, hypercalcemia, hypokalemia, dehydration, diabetes mellitus, hyperglycemia, hyperlipidemia, and weight increase. FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.

Cardiovascular

Cardiovascular side effects reported in clinical studies at an incidence of less than 2% were angina, arrhythmia, bradycardia, tachycardia, chest pain, edema, myocardial infarction, palpitation, hypertension, and vertigo.

Nervous system

Nervous system side effects reported in clinical studies at an incidence of less than 2% were convulsion, dizziness, headaches, migraine, paresthesia, psychomotor hyperactivity, tremor, pain, chills, pyrexia, auditory hallucination, trigeminal neuralgia, restless legs syndrome, and somnolence.

Renal

Renal system side effects reported in clinical studies at an incidence of less than 2% were dysuria and micturition urgency.

Psychiatric

Psychiatric system side effects reported in clinical studies at an incidence of less than 2% were abnormal dreams, anxiety, depression, insomnia, memory impairment, and libido changes.

Endocrine

Endocrine system side effects reported in clinical studies at an incidence of less than 2% were dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder, hot flushes, hypothyroidism, gout, lymphadenopathy, and goiter.

Ocular

Ocular system side effects reported in clinical studies at an incidence of less than 2% were eye irritation and eye swelling.

Hematologic

Hematologic system side effects reported in clinical studies at an incidence of less than 2% were anemia, epistaxis, neutropenia, thrombocythemia, increased neutrophils, MCHC decrease, and deep vein thrombosis.

Immunologic

Immunologic system side effects reported in clinical studies at an incidence of less than 2% were candida infections, influenza, pharyngitis, nasopharyngitis, oral herpes, sinusitis, viral infection, herpes zoster, and vulvovaginal infection. Postmarketing immunologic system side effects have included anaphylactic shock (requiring emergency intervention), Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal).

Hepatic

Hepatic system side effects reported in clinical studies at an incidence of less than 2% were biliary colic, cholelithiasis, and hepatomegaly.

Dermatologic

Dermatologic side effects reported in clinical studies at an incidence of less than 2% were acne, dermatitis, erythema, pruritus, rash, skin lesion, and urticaria.

General

General side effects reported in clinical studies at an incidence of less than 2% were ear pain, tinnitus, asthenia, chills, mucosal inflammation, nodule, sunburn, dysphonia, folliculitis, tonsillitis, altered taste, oral soft tissue disorder, and feeling abnormal.

Other

Other side effects reported in clinical studies at an incidence of less than 2% were ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, liver function test abnormal, platelet count decreased, and total protein increased.

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