Applies to bismuth subcitrate potassium / metronidazole / tetracycline: oral capsule.
Warning
Oral route (Capsule)
Potential for CarcinogenicityMetronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans.
Serious side effects
Along with its needed effects, bismuth subcitrate potassium/metronidazole/tetracycline 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 bismuth subcitrate potassium / metronidazole / tetracycline:
More common
- Belching
- chills
- cough
- darkened urine
- diarrhea
- fever
- general feeling of discomfort or illness
- headache
- heartburn
- indigestion
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- runny nose
- shivering
- sore or dry throat
- stomach discomfort, upset, or pain
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Less common
- Back pain
- black, tarry stools
- body aches or pain
- burning feeling in the chest or stomach
- burning while urinating
- chest pain
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urination
- hoarseness
- increased volume of pale, dilute urine
- itching of the vagina or genital area
- lack or loss of strength
- lower back or side pain
- pain during sexual intercourse
- painful or difficult urination
- pale skin
- rash with flat lesions or small raised lesions on the skin
- sneezing
- stuffy nose
- tender, swollen glands in the neck
- tenderness in the stomach area
- thick, white vaginal discharge with no odor or with a mild odor
- trouble with swallowing
- unusual bleeding or bruising
- voice changes
Rare
- Bloated feeling
- excess air or gas in the stomach or bowels
- feeling of fullness
- pain or tenderness around the eyes and cheekbones
- passing gas
- skin rash
- tightness of the chest
- trouble breathing
Incidence not known
- Blistering, peeling, loosening of the skin
- blurred or decreased vision
- burning, numbness, tingling, or painful sensations
- clumsiness
- itching
- pressure in the stomach
- red irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the stomach area
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
- white patches in the mouth or throat or on the tongue
Other side effects
Some side effects of bismuth subcitrate potassium / metronidazole / tetracycline 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
- Black or dark tongue
- black stools
Less common
- Change in taste, or bad, unusual, or unpleasant aftertaste
- dry mouth
- fear or nervousness
For Healthcare Professionals
Applies to bismuth subcitrate potassium / metronidazole / tetracycline: oral capsule.
General
The most commonly reported side effects included abnormal feces, nausea, and diarrhea.[Ref]
Gastrointestinal
Very common (10% or more): Abnormal feces (up to 15.6%)
Common (1% to 10%): Nausea, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth
Frequency not reported: Flatulence, glossitis, vomiting, tongue darkening, gastritis, gastroenteritis, duodenal ulcer
Postmarketing reports: Abdominal distention, eructation, flatulence, pseudomembranous colitis/Clostridium difficile colitis
Metronidazole:
Frequency not reported: Nausea, vomiting, diarrhea, abdominal pain, constipation, furry tongue, glossitis, stomatitis, dry mouth, pancreatitis
Tetracycline:
Frequency not reported: Nausea, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, anogenital region inflammatory lesions/inflammatory lesions with Candida overgrowth, esophagitis, esophageal ulceration[Ref]
Nervous system
Common (1% to 10%): Headache, dysgeusia, dizziness
Frequency not reported: Somnolence
Postmarketing reports: Peripheral neuropathy
Metronidazole:
Frequency not reported: Metallic taste, convulsive seizures, encephalopathy, aseptic meningitis, peripheral neuropathy, headache, syncope, dizziness, vertigo, incoordination, ataxia, dysarthria
Tetracycline:
Frequency not reported: Intracranial hypertension, pseudotumor cerebri[Ref]
Other
Common (1% to 10%): Asthenia, abnormal laboratory tests
Frequency not reported: Malaise
Postmarketing reports: Fatigue, candidiasis
Metronidazole:
Frequency not reported: Candida overgrowth, fever, weakness
Tetracycline:
Frequency not reported: Tinnitus[Ref]
Genitourinary
Common (1% to 10%): Vaginal infection, urine abnormality
Metronidazole:
Frequency not reported: Vaginal/vulvar dryness, dysuria, polyuria, incontinence, darkened urine, pelvic pressure, dyspareunia, proctitis[Ref]
Hepatic
Common (1% to 10%): ALT increase, AST increase
Tetracycline:
Frequency not reported: Hepatotoxicity, liver failure[Ref]
Dermatologic
Common (1% to 10%): Maculopapular rash
Uncommon (0.1% to 1%): Rash
Frequency not reported: Pruritus
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS)
Metronidazole:
Frequency not reported: Urticaria, erythematous rash, pruritus
Tetracycline:
Frequency not reported: Maculopapular/erythematous rash, onycholysis, nail discoloration, exfoliative dermatitis, photosensitivity, urticaria, Henoch-Schonlein purpura, systemic lupus erythematosus exacerbation[Ref]
Cardiovascular
Frequency not reported: Chest pain, tachycardia
Postmarketing reports: Chest discomfort
Metronidazole:
Frequency not reported: T-wave flattening, flushing
Tetracycline:
Frequency not reported: Pericarditis[Ref]
Metabolic
Frequency not reported: Increased appetite, increased weight
Metronidazole:
Frequency not reported: Anorexia
Tetracycline:
Frequency not reported: Anorexia[Ref]
Musculoskeletal
Frequency not reported: Back pain, increased blood creatinine phosphokinase, myalgia
Metronidazole:
Frequency not reported: Joint pain
Tetracycline:
Frequency not reported: Myasthenic syndrome[Ref]
Ocular
Frequency not reported: Visual disturbance
Metronidazole:
Frequency not reported: Optic neuropathy[Ref]
Hematologic
Metronidazole:
Frequency not reported: Reversible neutropenia/leukopenia, reversible thrombocytopenia
Tetracycline:
Frequency not reported: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, eosinophilia
Renal
Metronidazole:
Frequency not reported: Cystitis
Tetracycline:
Frequency not reported: Increased blood urea nitrogen
Psychiatric
Frequency not reported: Anxiety
Metronidazole:
Frequency not reported: Confusion, irritability, depression, insomnia, decreased libido[Ref]
Hypersensitivity
Tetracycline:
Frequency not reported: Angioedema, anaphylaxis[Ref]
Immunologic
Tetracycline:
Frequency not reported: Serum sickness-like reaction[Ref]
Respiratory
Metronidazole:
Frequency not reported: Nasal congestion[Ref]
