Summary

More frequently reported side effects include: diarrhea. Continue reading for a comprehensive list of adverse effects.

Applies to dexlansoprazole: oral capsule delayed release.

Serious side effects of Dexlansoprazole

Along with its needed effects, dexlansoprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dexlansoprazole:

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, tightness, or heaviness
• confusion
• continuing stomach pain
• diarrhea
• difficult or labored breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• incoherent speech
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• muscle pain, cramps, or weakness
• nausea
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, leg, back, or neck
• pounding in the ears
• rash, hives
• shakiness in the legs, arms, hands, or feet
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual bleeding or bruising
• vomiting
• vomiting of blood or material that looks like coffee grounds
• watery or bloody diarrhea

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine
• bloody nose
• bone fracture
• chills
• confusion
• cough
• decreased urine output
• drowsiness
• dry mouth
• heavier menstrual periods
• increased thirst
• itching
• joint or muscle pain
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• swelling of the body, feet, or ankles
• swollen glands
• trembling
• trouble speaking, thinking or walking
• unusual tiredness or weakness
• unusual weight gain

Other side effects of Dexlansoprazole

Some side effects of dexlansoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abnormal dreams
• body aches or pain
• bloated or full feeling
• burning or itching around the anus
• change in taste or bad, unusual, or unpleasant (after) taste
• continuing ringing or buzzing or other unexplained noise in the ears
• difficult or painful urination
• difficulty with moving
• ear congestion
• ear pain
• excess air or gas in the stomach or bowels
• falls
• feeling of constant movement of self or surroundings
• loss in sexual ability, desire, drive, or performance
• loss of voice
• metallic taste
• muscle or bone pain
• passing gas
• redness of the face, neck, arms, and occasionally, upper chest
• runny or stuffy nose
• sensation of spinning
• sneezing
• sunburn
• trouble sleeping

Incidence not known

• Blurred vision
• decreased interest in sexual intercourse
• inability to have or keep an erection

For Healthcare Professionals

Applies to dexlansoprazole: oral delayed release capsule.

General

The most commonly reported adverse reactions included diarrhea, abdominal pain, and nausea.^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, diarrhea, flatulence, nausea, vomiting

Frequency not reported: Abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett's esophagus, bezoar, bowel sounds abnormal, breath odor, Clostridium difficile-associated diarrhea, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, fundic gland polyps, 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 herpes, oral mucosal blistering, oropharyngeal pain, painful defecation, proctitis, paresthesia oral, rectal hemorrhage, rectal tenesmus, retching

Postmarketing reports: Oral edema, pancreatitis^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection

Frequency not reported: Influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, aspiration, asthma, bronchitis, cough, dysphonia, hiccups, hyperventilation, respiratory tract congestion, sore throat, epistaxis, tonsillitis, dyspnea

Postmarketing reports: Pharyngeal edema, throat tightness^[Ref]

Other

Frequency not reported: Adverse drug reaction, asthenia, chills, ear pain, falls, feeling abnormal, inflammation, mucosal inflammation, nodule, overdose, pain, procedural pain, pyrexia, tinnitus

Postmarketing reports: Deafness^[Ref]

Metabolic

Frequency not reported: Appetite changes, blood glucose increased, blood potassium increased, central obesity, cyanocobalamin (vitamin B12) deficiency, dehydration, diabetes mellitus, gout, hypercalcemia, hyperlipidemia, hypokalemia, hypomagnesemia, total protein increased, weight increased

Postmarketing reports: Hyponatremia^[Ref]

Nervous system

Frequency not reported: Altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, restless legs syndrome, somnolence, tremor, trigeminal neuralgia, vertigo

Postmarketing reports: Cerebrovascular accident, transient ischemic attack^[Ref]

Cardiovascular

Frequency not reported: Angina, arrhythmia, bradycardia, chest pain, deep vein thrombosis, edema, heart valve thickening risk, hot flush, hypertension, myocardial infarction, palpitation, tachycardia^[Ref]

Dermatologic

Frequency not reported: Acne, cutaneous lupus erythematosus, dermatitis, erythema, folliculitis, pruritus, rash, skin lesion, sunburn, urticaria

Postmarketing reports: Exfoliative dermatitis, facial edema, generalized rash, leukocytoclastic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)^[Ref]

Hepatic

Frequency not reported: Acute cholecystitis, ALP increased, ALT increased, AST increased, biliary colic, bilirubin decreased/increased, cholelithiasis, hepatomegaly, liver function test abnormal

Postmarketing reports: Drug-induced hepatitis^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthritis, bone fracture/fractures, bursitis, joint sprains, muscle cramps, musculoskeletal pain, myalgia, systemic lupus erythematosus^[Ref]

Genitourinary

Frequency not reported: Dysmenorrhea, dyspareunia, dysuria, menorrhagia, menstrual disorder, micturition urgency, vulvovaginal infection

Hematologic

Frequency not reported: Anemia, increased neutrophils, lymphadenopathy, mean corpuscular hemoglobin concentration (MCHC) decreased, neutropenia, platelet count decreased

Postmarketing reports: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura^[Ref]

Psychiatric

Frequency not reported: Abnormal dreams, anxiety, auditory hallucinations, depression, insomnia, libido changes^[Ref]

Immunologic

Frequency not reported: Candida infections, herpes zoster, influenza, viral infection^[Ref]

Endocrine

Frequency not reported: Blood gastrin increased, goiter, hypothyroidism^[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, hypersensitivity

Postmarketing reports: Anaphylactic shock (requiring emergency intervention)

Renal

Common (1% to 10%): Upper respiratory tract infection

Frequency not reported: Aspiration, asthma, bronchitis, cough, dysphonia, dyspnea, epistaxis, hiccups, hyperventilation, nasopharyngitis, pharyngitis, respiratory tract congestion, sinusitis, sore throat, tonsillitis

Postmarketing reports: Pharyngeal edema, throat tightness^[Ref]

Ocular

Frequency not reported: Eye irritation, eye swelling

Postmarketing reports: Blurred vision^[Ref]

Oncologic

Frequency not reported: B-cell lymphoma