Omeclamox-Pak Side Effects

Generic Name: amoxicillin / clarithromycin / omeprazole

Note: This page contains side effects data for the generic drug amoxicillin / clarithromycin / omeprazole. It is possible that some of the dosage forms included below may not apply to the brand name Omeclamox-Pak.

It is possible that some side effects of Omeclamox-Pak may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to amoxicillin / clarithromycin / omeprazole: therapy pack

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in taste; dry mouth; headache; indigestion; mild diarrhea or stomach pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur while taking amoxicillin / clarithromycin / omeprazole:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; 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; 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); stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent nausea or loss of appetite); tremor; trouble sleeping; unexplained weight loss; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

For Healthcare Professionals

Applies to amoxicillin / clarithromycin / omeprazole: oral kit

General

The most frequently reported side effects observed using combination therapy with omeprazole, clarithromycin and amoxicillin were diarrhea, taste perversion and headache

Cardiovascular

Clarithromycin:
Postmarketing reports: QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes

Omeprazole:
Postmarketing reports: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Dermatologic

Omeprazole:
Postmarketing reports: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Endocrine

Omeprazole:
Postmarketing reports: Gynecomastia

Gastrointestinal

Amoxicillin:
Postmarketing reports: Nausea, vomiting, diarrhea, and hemorrhagic/Clostridium difficile-associated colitis, tooth discoloration

Clarithromycin:
Common (1% to 10%): Diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain/discomfort
Postmarketing reports: Glossitis, stomatitis, oral moniliasis, anorexia, vomiting, pancreatitis, tongue discoloration, tooth discoloration

Omeprazole:
Common (1% to 10%): Abdominal pain, nausea, diarrhea, vomiting, flatulence, acid regurgitation, constipation
Postmarketing reports: Pancreatitis, anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, gastric fundic gland polyps, gastroduodenal carcinoids, taste perversion

Genitourinary

Omeprazole:
Postmarketing reports: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic

Amoxicillin:
Postmarketing reports: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, agranulocytosis, decrease WBC, elevated prothrombin time

Clarithromycin:
Postmarketing reports: Thrombocytopenia, leukopenia, neutropenia

Omeprazole:
Postmarketing reports: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

Hepatic

Amoxicillin:
Postmarketing reports: Moderate rise in AST (SGOT) and/or ALT (SGPT), hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis


Clarithromycin:
Postmarketing reports: Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, hepatic failure with fatal outcomes

Omeprazole:
Postmarketing reports: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests

Hypersensitivity

Amoxicillin:
Postmarketing reports: Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria

Clarithromycin:
Postmarketing reports: Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred

Metabolic

Clarithromycin:
Postmarketing reports: Hypoglycemia

Omeprazole:
Postmarketing reports: Hypoglycemia, hyponatremia, weight gain

Musculoskeletal

Omeprazole:
Common (1% to 10%): Asthenia, back pain
Postmarketing reports: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain

Nervous system

Amoxicillin:
Postmarketing reports: Reversible hyperactivity, agitation, insomnia, confusion, dizziness

Clarithromycin:
Common (1% to 10%): Headache
Postmarketing reports: Hearing loss, alterations of sense of smell, tinnitus, dizziness, vertigo, convulsions, insomnia, tremor

Omeprazole:
Common (1% to 10%): Headache, dizziness
Postmarketing reports: Nervousness, insomnia, somnolence, tinnitus

Ocular

Omeprazole:
Postmarketing reports: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Psychiatric

Amoxicillin:
Postmarketing reports: Anxiety, behavioral changes

Clarithromycin:
Postmarketing reports: Anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, manic behavior, nightmares, psychosis

Omeprazole:
Postmarketing reports: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, apathy, anxiety, and dream abnormalities

Renal

Amoxicillin:
Postmarketing reports: Crystalluria, elevated BUN, elevated serum creatinine

Clarithromycin:
Postmarketing reports: Interstitial nephritis

Respiratory

Omeprazole:
Common (1% to 10%): Upper respiratory infection, cough
Postmarketing reports: Epistaxis, pharyngeal pain

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