Applies to amoxicillin / omeprazole / rifabutin: oral capsule delayed release.
Serious side effects
Along with its needed effects, amoxicillin/omeprazole/rifabutin 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 / omeprazole / rifabutin:
Incidence not known
- Black, tarry stools
- bleeding gums
- blistering, peeling, loosening of the skin
- blood in the urine or stools
- blurred vision or other change in vision
- chest pain or tightness
- chills
- cloudy urine
- confusion
- cough
- cracks in the skin
- decreased urine
- diarrhea
- difficulty in moving
- difficulty with swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- eye pain
- fast heartbeat
- fever
- greatly decreased frequency of urination or amount of urine
- hives, itching, or skin rash
- increased thirst
- 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
- mood or mental changes
- muscle aches, cramps, pains, or stiffness
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- painful or difficult urination
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- red, irritated eyes
- red skin lesions, often with a purple center
- red, swollen skin
- scaly skin
- seizures
- sensitivity of the eye to light
- severe stomach cramps and pain
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach tenderness
- sweating
- swelling of the breasts or breast soreness in both females and males
- swelling of the feet or lower legs
- tearing
- trembling
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- watery and severe diarrhea, which may also be bloody
Other side effects
Some side effects of amoxicillin / omeprazole / rifabutin 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
- Headache
Less common
- Acid or sour stomach
- back pain
- belching
- change or loss of taste
- difficulty having a bowel movement (stool)
- heartburn
- indigestion
- itching of the vagina or genitals
- loss of appetite
- stomach discomfort or upset
- thick, white vaginal discharge with mild or no odor
- trouble sleeping
Incidence not known
- Change in taste bad unusual or unpleasant (after) taste
- continuing ringing or buzzing or other unexplained noise in ears
- dry skin
- hair loss or thinning of the hair
- hearing loss
- increased sweating
For Healthcare Professionals
Applies to amoxicillin / omeprazole / rifabutin: oral delayed release capsule.
General
The most commonly reported side effects included headache, diarrhea, chromaturia, and rash.[Ref]
Nervous system
Very common (10% or more): Headache (up to 15.6%)
Frequency not reported: Migraine
Amoxicillin:
Postmarketing reports: Convulsions, dizziness
Omeprazole:
Frequency not reported: Dizziness
Postmarketing reports: Double vision, dream abnormalities, hepatic encephalopathy, paresthesia, somnolence, taste perversion, tremors, vertigo
Rifabutin:
Frequency not reported: Taste perversion[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (up to 14.3%)
Common (1% to 10%): Abdominal pain, dyspepsia, nausea
Frequency not reported: Abdominal pain lower, abdominal pain upper, Clostridioides difficile-associated diarrhea, epigastric discomfort, oropharyngeal pain, vomiting
Amoxicillin:
Postmarketing reports: Black hairy tongue
Omeprazole:
Frequency not reported: Acid regurgitation, constipation, flatulence
Postmarketing reports: Abdominal swelling, dry mouth, fatal pancreatitis, fecal discoloration, fundic gland polyps, irritable colon, microscopic colitis, mucosal atrophy of the tongue, pancreatitis, stomatitis
Rifabutin:
Frequency not reported: Eructation, flatulence[Ref]
Genitourinary
Very common (10% or more): Chromaturia (up to 13%)
Common (1% to 10%): Vulvovaginal candidiasis
Frequency not reported: Vaginal discharge, vulvovaginal burning sensation, vulvovaginal mycotic infection, vulvovaginal pruritus
Amoxicillin:
Postmarketing reports: Crystalluria
Omeprazole:
Postmarketing reports: Glycosuria, hematuria, proteinuria, testicular pain, urinary frequency, urinary tract infection[Ref]
Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Maculopapular rash, morbilliform rash, urticaria
Amoxicillin:
Postmarketing reports: Thrombocytopenic purpura
Omeprazole:
Postmarketing reports: Alopecia, dry skin, hyperhidrosis, petechiae, photosensitivity, pruritus, purpura, urticaria
Rifabutin:
Frequency not reported: Skin discoloration[Ref]
Musculoskeletal
Frequency not reported: Cutaneous lupus erythematosus, systemic lupus erythematosus
Omeprazole:
Frequency not reported: Back pain
Postmarketing reports: Bone fracture, joint pain, leg pain, muscle cramps, muscle weakness, myalgia
Rifabutin:
Frequency not reported: Arthralgia, myalgia, myositis[Ref]
Hematologic
Amoxicillin:
Postmarketing reports: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia
Omeprazole:
Postmarketing reports: Agranulocytosis, anemia, hemolytic anemia, leukocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Rifabutin:
Frequency not reported: Anemia, hemolysis, leukopenia, pancytopenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, lymphopenia[Ref]
Other
Omeprazole:
Frequency not reported: Asthenia
Postmarketing reports: Tinnitus
Rifabutin:
Frequency not reported: Asthenia, fever, flu-like syndrome, pain[Ref]
Respiratory
Frequency not reported: Nasal congestion, nasopharyngitis
Omeprazole:
Frequency not reported: Cough, upper respiratory infection
Rifabutin:
Frequency not reported: Dyspnea[Ref]
Hepatic
Amoxicillin:
Postmarketing reports: Acute cytolytic hepatitis, cholestasis, cholestatic jaundice, liver dysfunction
Omeprazole:
Postmarketing reports: Cholestatic disease, fatal liver failure, fatal liver necrosis, hepatocellular disease, jaundice, mixed hepatitis
Rifabutin:
Frequency not reported: Hepatitis, jaundice[Ref]
Psychiatric
Amoxicillin:
Postmarketing reports: Agitation, anxiety, behavioral changes, confusion, hyperactivity, insomnia
Omeprazole:
Postmarketing reports: Aggression, agitation, anxiety, apathy, confusion, depression, hallucinations, insomnia, nervousness
Rifabutin:
Frequency not reported: Insomnia[Ref]
Cardiovascular
Omeprazole:
Postmarketing reports: Angina, bradycardia, elevated blood pressure, epistaxis, palpitations, peripheral edema, tachycardia
Rifabutin:
Frequency not reported: Chest pain[Ref]
Metabolic
Omeprazole:
Postmarketing reports: Anorexia, hypoglycemia, hypomagnesemia with/without hypocalcemia and/or hypokalemia, hyponatremia, weight gain
Rifabutin:
Frequency not reported: Anorexia[Ref]
Ocular
Frequency not reported: Uveitis
Omeprazole:
Postmarketing reports: Blurred vision, dry eye syndrome, ocular irritation, optic atrophy, optic neuritis[Ref]
Immunologic
Frequency not reported: Fungal infection
Omeprazole:
Postmarketing reports: Microscopic pyuria[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions[Ref]
Oncologic
Gastroduodenal carcinoids occurred as a manifestation of Zollinger-Ellison syndrome in patients who received long-term treatment; this condition is a manifestation of the underlying condition.[Ref]
Omeprazole:
Postmarketing reports: Gastroduodenal carcinoids[Ref]
Endocrine
Omeprazole:
Postmarketing reports: Gynecomastia[Ref]
Renal
Frequency not reported: Acute interstitial nephritis
Omeprazole:
Postmarketing reports: Elevated serum creatinine[Ref]
