Amoxicillin / clarithromycin / lansoprazole Side Effects

Some side effects of amoxicillin / clarithromycin / lansoprazole 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: oral kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking amoxicillin / clarithromycin / lansoprazole: 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:

• diarrhea that is watery or bloody;

• signs of new infection, such as fever, chills, body aches, flu symptoms, mouth sores;

• easy bruising or bleeding, unusual weakness;

• agitation, confusion, unusual thoughts or behavior;

• dizziness, fainting, fast or pounding heartbeat; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of amoxicillin / clarithromycin / lansoprazole may include:

• unusual or unpleasant taste in your mouth;

• headache;

• nausea, vomiting, stomach pain;

• constipation, dark colored stools;

• dry mouth, increased thirst; or

• vaginal itching or discharge.

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 amoxicillin / clarithromycin / lansoprazole: oral kit

Gastrointestinal

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

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

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

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

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.

Genitourinary

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

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.

Hepatic

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

Metabolic side effects have included gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, and weight gain/loss with the use of lansoprazole.

Ocular

Ocular side effects have included abnormal vision, blurred vision, conjunctivitis, dry eyes, eye pain, photophobia, retinal degeneration, and visual field defect.

Cardiovascular

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

Hypersensitivity side effects associated with amoxicillin / clarithromycin / lansoprazole including anaphylactic and anaphylactoid reactions have been reported in postmarketing experience.

Other

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

Endocrine side effects have included diabetes mellitus, goiter, and hypothyroidism with the use of lansoprazole.

Other

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.

Renal

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.

Local

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.

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