Prevpac Side Effects
Generic Name: amoxicillin / clarithromycin / lansoprazole
Note: This document contains side effect information about amoxicillin / clarithromycin / lansoprazole. Some of the dosage forms listed on this page may not apply to the brand name Prevpac.
Some side effects of Prevpac 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 amoxicillin / clarithromycin / lansoprazole: delayed-release therapy pack
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking amoxicillin / clarithromycin / lansoprazole:
Changes in taste; dry mouth; headache; indigestion; mild diarrhea or stomach pain; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or watery stools; bone pain; chest pain; confusion; decreased urination; dizziness; fast, slow, or irregular heartbeat; hallucinations; loss of taste or sense of smell; mental or mood changes (eg, depression); muscle pain or weakness; nightmares; one-sided weakness; pain, swelling, sores, or white patches in the mouth; purple spots on the skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; severe or persistent stomach pain (with or without nausea or vomiting); slurred speech; stomach cramps; tremor; trouble sleeping; unexplained weight loss; unusual bruising or bleeding; vaginal discharge, pain, or itching; unusual tiredness or weakness; vision changes.
For Healthcare Professionals
Applies to amoxicillin / clarithromycin / lansoprazole: oral kit
Gastrointestinal side effects have included diarrhea (7%) and taste perversion (5%). Dark stools, dry mouth/thirst, glossitis, rectal itching, nausea, oral moniliasis, stomatitis, tongue discoloration, tongue disorder, and vomiting have also been reported. Other side effects associated with the use of lansoprazole have included: abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, GI anomaly, GI disorder, GI hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, oral moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, and ulcerative stomatitis. Hemorrhagic/pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin and clarithromycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.
Musculoskeletal side effects have rarely included myalgia. Arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, and synovitis have been reported with the use of lansoprazole.
Nervous system side effects have included confusion and dizziness. Abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, and vertigo have been reported with the use of lansoprazole.
Respiratory side effects have included respiratory disorders. Asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, and stridor have been reported with the use lansoprazole.
Dermatologic side effects have included skin reactions. Acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, and urticaria have been reported during the use of lansoprazole. Severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, with some fatal cases, have been reported during the postmarketing of lansoprazole. Drug rash with eosinophilia and systemic symptoms (DRESS) and Henoch-Schonlein Purpura have been reported postmarketing for clarithromycin.
Genitourinary side effects have included vaginitis and vaginal moniliasis. Abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary tract infection, urinary urgency, and urination impaired have been reported with the use of lansoprazole. Urinary retention has been reported during the postmarketing period of lansoprazole, although a direct relationship has not been established.
Hematologic side effects have included anemia, hemolysis, and lymphadenopathy with the use of lansoprazole. Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura have been reported during the postmarketing of lansoprazole. Although a direct relationship has not been established. Hemorrhaging has been reported postmarketing with clarithromycin.
Hepatic side effects have included moderate elevations of AST (SGOT) and/or ALT (SGPT) levels with the use of amoxicillin and lansoprazole. Cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis with the use of amoxicillin. Abnormal liver function tests, increased alkaline phosphatase, bilirubinemia have also been reported with the use of lansoprazole.
Metabolic side effects have included gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, and weight gain/loss with the use of lansoprazole.
Ocular side effects have included abnormal vision, blurred vision, conjunctivitis, dry eyes, eye pain, photophobia, retinal degeneration, and visual field defect.
Cardiovascular side effects have included angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, and vasodilation with the use of lansoprazole.
Hypersensitivity side effects associated with amoxicillin / clarithromycin / lansoprazole including anaphylactic and anaphylactoid reactions have been reported in postmarketing experience.
Other side effects have included abdominal pain, abdomen enlarged, asthenia, chills, edema, fever, flu syndrome, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, and pelvic pain with the use of lansoprazole.
Endocrine side effects have included diabetes mellitus, goiter, and hypothyroidism with the use of lansoprazole.
Other side effects have included changes in laboratory parameters with the use of lansoprazole. These have included increased creatinine, increased alkaline phosphatase, increased globulins, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, eosinophilia, hyperlipemia, increased/decreased electrolyte, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, and increased gastrin levels. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported.
Amoxicillin can be removed from the body by hemodialysis.
Renal side effects have included kidney calculus and kidney pain. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdose. Renal side effects associated with clarithromycin, including interstitial nephritis, have been reported in postmarketing experience.
Tooth discoloration (brown, yellow, or gray staining) has been reported rarely with amoxicillin use. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Psychiatric side effects have included depression for clarithromycin postmarketing.
More about Prevpac (amoxicillin / clarithromycin / lansoprazole)
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