Dexlansoprazole Side Effects
Not all side effects for dexlansoprazole may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to dexlansoprazole: oral capsule delayed release
In addition to its needed effects, some unwanted effects may be caused by dexlansoprazole. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking dexlansoprazole:Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chest tightness or heaviness
- continuing stomach pain
- difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- incoherent speech
- joint pain, stiffness, or swelling
- lightheadedness, dizziness, or fainting
- mood changes
- muscle pain, cramps, or weakness
- nausea or vomiting
- 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 or hives
- shakiness in the legs, arms, hands, or feet
- 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 of blood or material that looks like coffee grounds
- watery or bloody diarrhea
- muscle spasms (tetany) or twitching
Some of the side effects that can occur with dexlansoprazole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common
- Abnormal dreams
- 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 pain
- 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
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- trouble sleeping
For Healthcare Professionals
Applies to dexlansoprazole: oral delayed release capsule
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 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 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 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 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 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 system side effects reported in clinical studies at an incidence of less than 2% were dysuria and micturition urgency.
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 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 system side effects reported in clinical studies at an incidence of less than 2% were eye irritation and eye swelling.
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 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 system side effects reported in clinical studies at an incidence of less than 2% were biliary colic, cholelithiasis, and hepatomegaly.
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 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 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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