Helidac Side Effects

Generic name: bismuth subsalicylate / metronidazole / tetracycline

Note: This document contains side effect information about bismuth subsalicylate / metronidazole / tetracycline. Some of the dosage forms listed on this page may not apply to the brand name Helidac.

Some side effects of Helidac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bismuth subsalicylate / metronidazole / tetracycline: oral kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking bismuth subsalicylate / metronidazole / tetracycline: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe diarrhea, or diarrhea that is watery or bloody;

• confusion, severe headache, ringing in your ears, dizziness;

• vision problems, pain behind your eyes;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• seizure (convulsions); or

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

• stomach pain, indigestion, vomiting;

• constipation, mild diarrhea;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• mouth pain, metallic taste in your mouth;

• vaginal itching or discharge;

• mild headache; or

• swollen tongue, black or "hairy" tongue, trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bismuth subsalicylate / metronidazole / tetracycline: oral kit

Cardiovascular

Cardiovascular side effects have rarely included flattening of the T-wave in electrocardiographic tracings.

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently, but rarely led to discontinuation of therapy. These have included nausea, diarrhea, abdominal pain, melena, constipation, vomiting, discolored tongue, dyspepsia, stool abnormality, duodenal ulcer, taste perversion, flatulence, GI hemorrhage, anal discomfort, dry mouth, dysphagia, eructation, GI monilia, glossitis, intestinal obstruction, rectal hemorrhage, and stomatitis. A sharp, unpleasant metallic taste is not unusual with the use of metronidazole.

A furry tongue, glossitis, stomatitis have been reported during therapy with metronidazole. These may be associated with a sudden overgrowth of Candida which may occur during therapy.

Rare instances of esophagitis and esophageal ulceration have been reported in patients taking the tetracycline-class antibiotics. In most of these cases, the patient took the medication immediately before going to bed.

The darkening of the tongue associated with the use of bismuth subsalicylate is considered a temporary and harmless adverse reaction.

Dermatologic

Dermatologic side effects have been reported rarely. These have included acne, ecchymosis, photosensitivity reaction, pruritus, and rash. Maculopapular and erythematous rashes have been reported with the use of tetracyclines. Exfoliative dermatitis, photosensitivity, onycholysis, and discoloration of the nails have also been reported rarely.

Other

Other side effects have rarely included flu syndrome, infection, malaise, neoplasm, syncope, and tooth disorder.

Respiratory

Respiratory side effects have included upper respiratory infection, sinusitis, and rhinitis.

Ocular

Ocular side effects have rarely included conjunctivitis.

Metabolic

Metabolic side effects have rarely included increases in SGOT and SGPT.

Musculoskeletal

Musculoskeletal side effects have included asthenia, arthritis, rheumatoid arthritis, and tendonitis. Enamel hypoplasia has been reported with the use of tetracyclines.

Nervous system

Persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole. Patients should be warned to stop treatment and to consult with their doctor if numbness or paresthesia of an extremity occurs.

Nervous system side effects have rarely included nervousness, dizziness, insomnia, and somnolence. Pseudotumor cerebri and myasthenic syndrome have been reported rarely with the use of tetracyclines. Two serious side effects reported with the use of metronidazole have been convulsive seizures and peripheral neuropathy. Patients should be advised to stop treatment and consult with their physicians if any neurologic symptoms occur.

Hematologic

Hematologic side effects have included reversible neutropenia (leukopenia) with the use of metronidazole. Reversible thrombocytopenia has also been reported rarely. Hemolytic anemia, thrombocytopenia, thrombocytopenia purpura, neutropenia, and eosinophilia have been reported with the use of tetracyclines.

Other

Tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland when used over long periods. Thyroid function studies are reported to remain normal.

Hepatic

Hepatic side effects have included hepatotoxicity and liver failure in patients receiving large doses of tetracyclines. Increases in liver enzymes and hepatic toxicity has been reported rarely in patients with renal impairment treated with tetracyclines.

Hypersensitivity

Hypersensitivity side effects have included urticaria, erythematous rash, flushing, nasal congestion, dryness of mouth (or vagina or vulva), and fever with the use of metronidazole. Angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, urticaria, and serum sickness-like reactions, as fever, rash and arthralgia have been reported with the use of tetracyclines.

Renal

Instances of darkening of the urine have been reported by approximately one patient in 100,000. It is believed a metabolite of metronidazole, with no clinical significance, is responsible for this rare occurrence.

Renal side effects have included urinary tract infection. Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure have been reported with the use of metronidazole. Darkening of the urine has been reported rarely. Rise in BUN has been reported with the use of tetracyclines.

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