Kapidex side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Kapidex: 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; or
- worsening heartburn.
Less serious Kapidex side effects may include:
- nausea, vomiting, stomach pain, gas;
- 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. You may report side effects to FDA at 1-800-FDA-1088.
Some side effects of Kapidex 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 capsule delayed release
Along with its needed effects, dexlansoprazole (the active ingredient contained in Kapidex) 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:
- Acid or sour stomach
- black, tarry stools
- bleeding after defecation
- bleeding from the rectum or bloody stools
- bloated or full feeling
- blurred vision
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chest tightness or heaviness
- continuing diarrhea
- continuing stomach pain
- cracked lips
- decreased urine
- deep or fast breathing with dizziness
- difficult or labored breathing
- dry mouth
- excess air or gas in the stomach
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of heat
- gaseous abdominal or stomach pain
- headache, severe and throbbing
- incoherent speech
- increased thirst
- increased urination
- joint pain, stiffness, or swelling
- lightheadedness, dizziness, or fainting
- loss of appetite
- metallic taste
- mood changes
- muscle pain or cramps
- muscle weakness
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain or burning in the throat
- pain or discomfort in the arms, jaw, leg, back, or neck
- pale skin
- passing of gas
- pounding in the ears
- recurrent fever
- redness of the skin
- right upper abdominal or stomach pain and fullness
- shakiness in the legs, arms, hands, or feet
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach cramps
- stomach discomfort, fullness, upset, or pain
- swelling of the eyelids, face, lips, hands, or feet
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tenderness in the stomach area
- troubled breathing with exertion
- uncomfortable swelling around the anus
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- watery or bloody diarrhea
- weight loss
- yellow eyes or skin
Incidence not known
- muscle spasms (tetany) or twitching
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:
- Abnormal dreams
- blemishes on the skin
- blistering, crusting, irritation, itching, or reddening of the skin
- body aches or pain
- bumps on the skin
- burning or itching around the anus
- burning while urinating
- change in taste or bad, unusual, or unpleasant (after) taste
- changes in appetite
- changes in menstrual periods
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, or scaly skin
- decreased interest in sexual intercourse
- decreased sexual ability in males
- difficult or painful urination
- difficulty with moving
- dry, puffy skin
- ear congestion
- ear pain
- excess air or gas in the stomach or intestines
- feeling cold
- feeling of constant movement of self or surroundings
- feeling of warmth
- frequent strong or increased urge to urinate
- general feeling of discomfort or illness
- hearing loss
- heavy bleeding
- hives or welts
- inability to have or keep an erection
- lack or loss of strength
- longer or heavier menstrual periods
- loss in sexual ability, desire, drive, or performance
- loss of voice
- muscle or bone pain
- muscle stiffness
- noisy breathing
- pain around the anus
- pain or tenderness around the eyes and cheekbones
- pain, swelling, or redness in the joints
- painful sexual intercourse
- red, sore eyes
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- sore throat
- stuffy or runny nose
- sudden sweating
- thick, white, or curd-like vaginal discharge
- trouble remembering
- trouble sleeping
- unable to sleep
- voice changes
- weight gain
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.
Drugs & Medications – Kapidex Oral
KAPIDEX ORAL USES
Dexlansoprazole is used to treat certain stomach and esophagus problems (such asacid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Dexlansoprazole may also be used to treat stomach ulcers.
How to use Kapidex oral
Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking dexlansoprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily with or without food. If your symptoms usually occur after a meal, your doctor may direct you to take your dose every day before the same meal for best results. Dosage and length of treatment are based on your medical condition and response to treatment.
Do not crush or chew the capsules. Swallow this medication whole. If you have trouble swallowing this medication whole, you may open the capsule and sprinkle the contents onto 1 tablespoon (15 milliliters) of applesauce. Swallow all of the drug/food mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.
If you are giving this drug with a liquid medication measuring device/syringe, or through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take dexlansoprazole at least 30 minutes before sucralfate.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.
Tell your doctor if your condition persists or worsens.
Kapidex Delayed Release Capsules
Kapidex (dexlansoprazole delayed release capsules) is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid). It decreases the amount of acid produced in the stomach. Common side effects include nausea, vomiting, stomach pain, gas, diarrhea, or stuffy nose, sneezing, or other cold symptoms.
The recommended adult dose of Kapidex is 30 mg or 60 mg, taken once daily as directed. Kapidex may interact with ampicillin, atazanavir, clopidogrel, digoxin, ketoconazole, blood thinners, or iron. Tell your doctor all medications and supplements you use. Kapidex is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Kapidex (dexlansoprazole delayed release capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Clinical Trials Experience
The safety of KAPIDEX (dexlansoprazole delayed release capsules) 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 (dexlansoprazole delayed release capsules) 30 mg, 2218 patients on KAPIDEX (dexlansoprazole delayed release capsules) 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
Adverse Reactions Resulting in Discontinuation
In controlled clinical studies, the most common adverse reaction leading to discontinuation from KAPIDEX (dexlansoprazole delayed release capsules) 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