Applies to amoxicillin / clarithromycin / lansoprazole: oral capsule, oral capsule delayed release, oral tablet.

Serious side effects

Along with its needed effects, amoxicillin/clarithromycin/lansoprazole 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 amoxicillin / clarithromycin / lansoprazole:

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• clay colored stools
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness or fainting
• fast, slow, or irregular heartbeat
• fever
• headache
• hives, itching, or skin rash
• joint or muscle pain
• loss of appetite
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or tenderness
• swelling of the body, feet, and ankles
• tightness in the chest
• unusual tiredness or weakness
• unusual weight gain
• vomiting
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

Other side effects

Some side effects of amoxicillin / clarithromycin / lansoprazole 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:

More common

• Bad, unusual or unpleasant (after) taste
• change in taste

Less common

• Confusion
• discoloration of the tongue
• itching of the vagina or genital area
• pain during sexual intercourse
• redness, swelling, or soreness of the tongue
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

For Healthcare Professionals

Applies to amoxicillin / clarithromycin / lansoprazole: oral kit.

General

The most commonly reported side effects included diarrhea, headache, and taste perversion.

Amoxicillin: The most commonly reported side effects included nausea, diarrhea, rash, and vomiting.

Clarithromycin: The most commonly reported side effects included abdominal pain, diarrhea, nausea/vomiting, and dysgeusia.

Lansoprazole: The most commonly reported side effects included abdominal pain, diarrhea, and nausea.^[Ref]

Nervous system

Common (1% to 10%): Headache, taste perversion

Frequency not reported: Dizziness

Amoxicillin:

Common (1% to 10%): Headache, taste perversion

Frequency not reported: Dizziness, hyperactivity/reversible hyperactivity

Clarithromycin:

Common (1% to 10%): Dysgeusia, headache

Frequency not reported: Dizziness, dyskinesia, loss of consciousness, somnolence, tremor, vertigo

Postmarketing reports: Ageusia, anosmia, convulsion, paresthesia, parosmia

Lansoprazole:

Frequency not reported: Amnesia, cerebrovascular accident/cerebral infarction, convulsion, dementia, dizziness, headache, hemiplegia, hyperkinesia, hypertonia, hypesthesia, migraine, paresthesia, parosmia, somnolence, syncope, taste loss/perversion, tremor, vertigo

Postmarketing reports: Speech disorder^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea

Frequency not reported: Abdominal pain, dark stools, dry mouth, glossitis, nausea, oral moniliasis, rectal itching, stomatitis, tongue discoloration/disorder, vomiting

Amoxicillin:

Common (1% to 10%): Diarrhea, nausea, vomiting

Frequency not reported: Black hairy tongue, hemorrhagic/pseudomembranous colitis, tooth discoloration/brown, yellow or gray staining of teeth

Clarithromycin:

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

Frequency not reported: Abdominal distension, constipation, dry mouth, eructation, esophagitis, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, glossitis, proctalgia, stomatitis

Postmarketing reports: Acute pancreatitis, pseudomembranous colitis, tongue/tooth discoloration

Lansoprazole:

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

Frequency not reported: Abnormal stools, bezoar, cardiospasm, colitis, dry mouth, dyspepsia, dysphagia, enlarged abdomen, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, glossitis, gum hemorrhage, halitosis, hematemesis, increased salivation, melena, mouth ulceration, rectal disorder/hemorrhage, stomatitis, tenesmus, tongue disorder, ulcerative colitis/stomatitis, vomiting

Postmarketing reports: Clostridium difficile-associated diarrhea, pancreatitis, positive fecal occult blood^[Ref]

Genitourinary

Frequency not reported: Vaginal moniliasis, vaginitis

Amoxicillin:

Frequency not reported: Crystalluria

Clarithromycin:

Frequency not reported: Vaginal infection

Postmarketing reports: Abnormal urine color

Lansoprazole:

Frequency not reported: Abnormal menses, breast enlargement/pain/tenderness, dysmenorrhea, dysuria, impaired urination, impotence, leukorrhea, menorrhagia, menstrual disorder, pelvic pain, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, vaginitis

Postmarketing reports: Albuminuria, hematuria, presence of crystal urine, urine abnormalities^[Ref]

Dermatologic

Frequency not reported: Skin reactions

Amoxicillin:

Common (1% to 10%): Rash

Frequency not reported: Acute generalized exanthematous pustulosis, erythematous maculopapular rashes, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, mucocutaneous candidiasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Clarithromycin:

Common (1% to 10%): Rash

Frequency not reported: Cellulitis, dermatitis bollus, hyperhidrosis, maculopapular rash, pruritus, urticaria

Postmarketing reports: Acne, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis

Lansoprazole:

Frequency not reported: Acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin disorder, sweating, urticaria

Postmarketing reports: Cutaneous lupus erythematosus, erythema multiforme, severe dermatologic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)/fatal TEN^[Ref]

Psychiatric

Frequency not reported: Confusion

Amoxicillin:

Frequency not reported: Agitation, anxiety, behavioral change, confusion, insomnia

Clarithromycin:

Common (1% to 10%): Insomnia

Frequency not reported: Anxiety, nervousness

Postmarketing reports: Abnormal behavior/dreams, confusion, confusional state, depersonalization, depression, disorientation, hallucination, manic behavior, psychotic disorder

Lansoprazole:

Frequency not reported: Abnormal dreams/thinking, aggravated hostility, agitation, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hallucinations, insomnia, increased/decreased libido, nervousness, neurosis, sleep disorders^[Ref]

Musculoskeletal

Frequency not reported: Myalgia

Clarithromycin:

Frequency not reported: Muscle spasms, myalgia, nuchal rigidity

Postmarketing reports: Myopathy, rhabdomyolysis

Lansoprazole:

Frequency not reported: Arthralgia, arthritis, back pain, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, neck pain/rigidity, synovitis

Postmarketing reports: Bone fracture, myositis, systemic lupus erythematosus^[Ref]

Other

Frequency not reported: Thirst

Clarithromycin:

Frequency not reported: Chills, fatigue, hearing loss, malaise, pyrexia, tinnitus

Postmarketing reports: Deafness, death

Lansoprazole:

Frequency not reported: Asthenia, chills, deafness, ear disorder, fever, malaise, otitis media, pain, thirst, tinnitus

Postmarketing reports: Increased globulins^[Ref]

Respiratory

Frequency not reported: Respiratory disorders

Clarithromycin:

Frequency not reported: Asthma, epistaxis, pulmonary embolism

Lansoprazole:

Frequency not reported: Asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor^[Ref]

Hematologic

Amoxicillin:

Frequency not reported: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura

Clarithromycin:

Frequency not reported: Abnormal albumin globulin ratio, eosinophilia, leukopenia, neutropenia, thrombocythemia

Postmarketing reports: Agranulocytosis, decreased white blood cell count, increased INR, prolonged prothrombin time, thrombocytopenia

Lansoprazole:

Frequency not reported: Anemia, hemolysis, lymphadenopathy

Postmarketing reports: Abnormal AG ratio/red blood cells, abnormal/increased/decreased white blood cells/platelets, agranulocytosis, aplastic anemia, decreased hemoglobin, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura^[Ref]

Hepatic

Amoxicillin:

Frequency not reported: Acute cytolytic hepatitis, cholestatic jaundice, hepatic dysfunction/cholestasis, moderate AST/ALT elevation

Clarithromycin:

Common (1% to 10%): Abnormal liver function tests

Frequency not reported: Cholestasis, hepatitis, increased blood bilirubin

Postmarketing reports: Hepatic dysfunction/failure, hepatocellular jaundice

Lansoprazole:

Frequency not reported: Cholelithiasis

Postmarketing reports: Abnormal liver function tests, bilirubinemia, hepatotoxicity, increased AST/ALT/gamma glutamyl transpeptidase^[Ref]

Hypersensitivity

Amoxicillin:

Frequency not reported: Anaphylaxis, hypersensitivity phenomena

Clarithromycin:

Common (1% to 10%): Anaphylactoid reaction

Frequency not reported: Hypersensitivity

Postmarketing reports: Anaphylactic reaction

Lansoprazole:

Frequency not reported: Allergic reaction

Postmarketing reports: Anaphylactic/anaphylactoid reactions^[Ref]

Metabolic

Clarithromycin:

Frequency not reported: Anorexia, decreased appetite, increased blood alkaline phosphatase/lactate dehydrogenase

Postmarketing reports: Hypoglycemia

Lansoprazole:

Frequency not reported: Anorexia, avitaminosis, dehydration, diabetes mellitus, gout, hyperglycemia, hypoglycemia, increased appetite, weight gain/loss

Postmarketing reports: Hyperlipemia, hypomagnesemia, increased alkaline phosphatase/blood potassium/lactate dehydrogenase, increased/decreased electrolytes/cholesterol^[Ref]

Cardiovascular

Clarithromycin:

Frequency not reported: Atrial fibrillation, cardiac arrest, chest pains, electrocardiogram QT prolonged, extrasystoles, palpitations

Postmarketing reports: Hemorrhage, torsade de pointes, ventricular arrhythmia/tachycardia

Lansoprazole:

Frequency not reported: Angina, arrhythmia, bradycardia, chest pain (not otherwise specified), edema, hypertension/hypotension, myocardial infarction, palpitations, peripheral edema, shock/circulatory failure, tachycardia, vasodilation^[Ref]

Renal

Clarithromycin:

Frequency not reported: Increased blood creatinine/urea

Postmarketing reports: Interstitial nephritis, renal failure

Lansoprazole:

Frequency not reported: Kidney calculus, kidney pain

Postmarketing reports: Glycosuria, increased creatinine/blood urea, interstitial nephritis^[Ref]

Ocular

Lansoprazole:

Frequency not reported: Abnormal vision, amblyopia, blepharitis, blurred vision, cataracts, conjunctivitis, diplopia, dry eyes, eye disorder, eye pain, glaucoma, photophobia, ptosis, retinal degeneration/disorder, visual field defect^[Ref]

Endocrine

Lansoprazole:

Frequency not reported: Goiter, gynecomastia, hypothyroidism

Postmarketing reports: Increased glucocorticoids/gastrin levels^[Ref]

Oncologic

Lansoprazole:

Frequency not reported: Carcinoma, laryngeal neoplasia, skin carcinoma^[Ref]

Immunologic

Amoxicillin:

Frequency not reported: Serum sickness-like reaction

Clarithromycin:

Common (1% to 10%): Candidiasis

Frequency not reported: Infection

Lansoprazole:

Frequency not reported: Candidiasis, flu syndrome, infection (not otherwise specified)^[Ref]