Omeclamox-Pak Side Effects
Generic name: amoxicillin / clarithromycin / omeprazole
Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.
Note: This document provides detailed information about Omeclamox-Pak Side Effects associated with amoxicillin / clarithromycin / omeprazole. Some dosage forms listed on this page may not apply specifically to the brand name Omeclamox-Pak.
Applies to amoxicillin / clarithromycin / omeprazole: oral capsule, oral capsule delayed release, oral tablet.
Precautions
It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.
Do not use this medicine if you are also using certain ergot medicines (eg, dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®) or pimozide (Orap®). Using these medicines together may increase risk for more serious side effects.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cracks in the skin, cough, diarrhea, joint or muscle pain, loss of heat from the body, red irritated eyes, red or swollen skin, red skin lesions, often with a purple center, scaly skin, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat, or unusual tiredness or weakness while you are using this medicine.
Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, tell your doctor right away.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you Stop taking amoxicillin/clarithromycin/omeprazole. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of acute tubulointerstitial nephritis.
Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese before using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of Omeclamox-Pak
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 side effects
- bad, unusual, or unpleasant (after) taste
- change in taste
- headache
Incidence not known
- hair loss, thinning of the hair
Serious side effects of Omeclamox-Pak
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
For healthcare professionals
Applies to amoxicillin / clarithromycin / omeprazole: oral kit.
General adverse events
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]
See also:
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Clarithromycin
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Lansoprazole
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Esomeprazole
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References
1. (2013) "Product Information. Omeclamox-Pak (amoxicillin / clarithromycin / omeprazole)." Pernix Therapeutics
More about Omeclamox-Pak (amoxicillin / clarithromycin / omeprazole)
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- During pregnancy
- Drug class: H. pylori eradication agents
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Further information
Omeclamox-Pak side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.