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

Serious side effects

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

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cracks in the skin
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever or chills
• hives or welts, itching, or skin rash
• increased sensitivity of the skin to sunlight
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• muscle pain or weakness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, swollen skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness of the skin
• redness or discoloration of the skin
• scaly skin
• severe sunburn
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach tenderness, cramps, or pain
• swelling of the body, feet, and ankles
• tightness in the chest
• unusual tiredness or weakness
• unusual weight gain
• watery and severe diarrhea, which may also be bloody

Other side effects

Some side effects of amoxicillin / clarithromycin / omeprazole 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
• headache

Incidence not known

• Hair loss, thinning of the hair

For Healthcare Professionals

Applies to amoxicillin / clarithromycin / omeprazole: oral kit.

General

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

Clarithromycin: The most commonly reported side effects included diarrhea, nausea, and abnormal taste.

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

Gastrointestinal

Very common (10% or more): Diarrhea (up to 14%), taste perversion (up to 10%)

Frequency not reported: Clostridium difficile-associated diarrhea

Amoxicillin:

Postmarketing reports: Diarrhea, hemorrhagic/Clostridium difficile-associated colitis, nausea, tooth discoloration, vomiting

Clarithromycin:

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

Postmarketing reports: Glossitis, oral moniliasis, pancreatitis, stomatitis, tooth/tongue discoloration, vomiting

Omeprazole:

Common (1% to 10%): Abdominal pain, acid regurgitation, constipation, diarrhea, flatulence, nausea, vomiting

Postmarketing reports: Abdominal swelling, dry mouth, esophageal candidiasis, fecal discoloration, gastric fundic gland polyps, irritable colon, mucosal atrophy of the tongue, pancreatitis/fatal pancreatitis, stomatitis^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Myasthenia gravis

Amoxicillin:

Postmarketing reports: Dizziness, reversible hyperactivity

Clarithromycin:

Common (1% to 10%): Abnormal taste, headache

Postmarketing reports: Altered sense of smell, convulsions, dizziness, taste perversion/loss, tremor, vertigo

Omeprazole:

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

Postmarketing reports: Hepatic encephalopathy, paresthesia, somnolence, taste perversion, tremors, vertigo^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity

Clarithromycin:

Postmarketing reports: Allergic reactions, anaphylaxis

Omeprazole:

Postmarketing reports: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reactions^[Ref]

Metabolic

Amoxicillin:

Postmarketing reports: Elevated alkaline phosphatase/lactate dehydrogenase

Clarithromycin:

Very rare (less than 0.01%): Anorexia

Postmarketing reports: Hypoglycemia

Omeprazole:

Postmarketing reports: Anorexia, hypoglycemia, hyponatremia, weight gain^[Ref]

Dermatologic

Amoxicillin:

Postmarketing reports: Acute generalized exanthematous pustulosis, erythema multiforme, erythematous maculopapular rashes, exfoliative dermatitis, hypersensitivity vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Clarithromycin:

Postmarketing reports: Mild skin eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Omeprazole:

Common (1% to 10%): Rash

Postmarketing reports: Alopecia, dry skin, erythema hyperhidrosis, multiforme, petechia, photosensitivity, severe generalized skin reactions, skin inflammation pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis/fatal toxic epidermal necrolysis, urticaria^[Ref]

Hepatic

Amoxicillin:

Postmarketing reports: Acute cytolytic hepatitis, AST/ALT/GGT/total bilirubin elevation, cholestatic jaundice, hepatic dysfunction, hepatic cholestasis

Clarithromycin:

Postmarketing reports: Cholestatic/hepatocellular hepatitis with/without jaundice, hepatic dysfunction, haptic failure with fatal outcome, increased liver enzymes

Omeprazole:

Postmarketing reports: Cholestatic disease, hepatic failure/fatal hepatic failure, hepatocellular disease, jaundice, liver disease, liver necrosis/fatal liver necrosis, liver function test elevations (e.g., AST, ALT, bilirubin, GGT, alkaline phosphatase), mixed hepatitis^[Ref]

Hematologic

Amoxicillin:

Postmarketing reports: Agranulocytosis, anemia, decreased white blood cells, eosinophilia, hemolytic anemia, increased prothrombin time, leukopenia, thrombocytopenia, thrombocytopenic purpura

Clarithromycin:

Postmarketing reports: Leukopenia, neutropenia, thrombocytopenia

Omeprazole:

Postmarketing reports: Agranulocytosis/fatal agranulocytosis, anemia, hemolytic anemia, leukocytosis, leukopenia, neutropenia, pancytopenia, purpura, thrombocytopenia^[Ref]

Psychiatric

Amoxicillin:

Postmarketing reports: Agitation, anxiety, behavioral changes, confusion, insomnia

Clarithromycin:

Postmarketing reports: Anxiety, behavioral changes, confusional state, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis

Omeprazole:

Postmarketing reports: Aggression, agitation, anxiety, apathy, confusion, depression, dream abnormalities, hallucination, insomnia, nervousness, psychiatric and sleep disturbances^[Ref]

Renal

Amoxicillin:

Postmarketing reports: Elevated blood urea nitrogen (BUN)/serum creatinine

Clarithromycin:

Postmarketing reports: Interstitial nephritis

Omeprazole:

Postmarketing reports: Glycosuria, increased serum creatinine, interstitial nephritis^[Ref]

Other

Clarithromycin:

Postmarketing reports: Hearing loss, tinnitus

Omeprazole:

Common (1% to 10%): Asthenia

Postmarketing reports: Fatigue, fever, malaise, pain, tinnitus^[Ref]

Cardiovascular

Clarithromycin:

Postmarketing reports: QT prolongation, torsade de pointes, ventricular arrhythmia/tachycardia

Omeprazole:

Postmarketing reports: Angina, blood pressure elevation, bradycardia, chest pain palpitations, peripheral edema, tachycardia^[Ref]

Genitourinary

Amoxicillin:

Postmarketing reports: Crystalluria

Omeprazole:

Postmarketing reports: Hematuria, microscopic pyuria, proteinuria, testicular pain, urinary frequency, urinary tract infection^[Ref]

Respiratory

Omeprazole:

Common (1% to 10%): Cough, Upper respiratory tract infection

Postmarketing reports: Bronchospasm, epistaxis, pharyngeal pain^[Ref]

Musculoskeletal

Omeprazole:

Common (1% to 10%): Back pain

Postmarketing reports: Joint pain, leg pain, muscle cramps/weakness, myalgia^[Ref]

Ocular

Omeprazole:

Postmarketing reports: Anterior ischemic optic neuropathy, blurred vision, double vision, dry eye syndrome, ocular irritation, optic atrophy, optic neuritis^[Ref]

Oncologic

Omeprazole:

Postmarketing reports: Gastroduodenal carcinoma^[Ref]

Endocrine

Omeprazole:

Postmarketing reports: Gynecomastia^[Ref]

Immunologic

Amoxicillin:

Frequency not reported: Serum sickness-like reaction^[Ref]