Dexlansoprazole Side Effects

Some side effects of dexlansoprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dexlansoprazole: oral delayed release capsule

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

Call your doctor at once if you have a serious side effect such as:

• chest pain, fast or pounding heartbeats;

• severe stomach pain;

• diarrhea that is watery or bloody;

• worsening heartburn; or

• low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure).

Less serious side effects of dexlansoprazole may include:

• nausea, vomiting, stomach pain, gas;

• mild diarrhea; or

• stuffy nose, sneezing, 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.

For Healthcare Professionals

Applies to dexlansoprazole: oral delayed release capsule

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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