Helidac Side Effects

Please note - some side effects for Helidac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Helidac - for the Consumer

Helidac Therapy Pack

Every medicine can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Helidac Therapy Pack:

Constipation; darkening of the tongue or stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision; black, hairy tongue or sore tongue; dark urine; depression; loss of coordination; numbness or tingling in the hands or feet; pale stools; red or blistered skin; seizures; severe or persistent headache or stomach pain; signs of infection (eg, fever, chills, or persistent sore throat); sore mouth; unusual bruising or bleeding; vaginal odor or discharge; white patches in the mouth or on the tongue; yellowing of the eyes or skin.

Helidac Side Effects - for the Professional

Helidac

The most common adverse reactions (≥ 1%) reported in clinical trials when all three components of this therapy were given concomitantly are listed in the table below. The majority of the adverse reactions were related to the gastrointestinal tract, were reversible, and infrequently led to discontinuation of therapy.

Incidence of Adverse Reactions Reported
in Clinical Trials (≥ 1%)†

The additional adverse reactions (< 1%) reported in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body system:

Gastrointestinal: dry mouth, dysphagia, eructation, GI monilia, glossitis, intestinal obstruction, rectal hemorrhage, stomatitis

Skin: acne, ecchymosis, photosensitivity reaction, pruritus, rash

Cardiovascular: cerebral ischemia, chest pain, hypertension, myocardial infarction

CNS: nervousness, somnolence

Musculoskeletal: arthritis, rheumatoid arthritis, tendonitis

Metabolic: SGOT increase, SGPT increase

Urogenital: urinary tract infection

Other: conjunctivitis, flu syndrome, infection, malaise, neoplasm, rhinitis, syncope, tooth disorder

The following adverse reactions from the labeling for bismuth subsalicylate are provided for information.

Gastrointestinal: black stools

Mouth: temporary and harmless darkening of the tongue

The following adverse reactions from the labeling for metronidazole are provided for information.

Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, and abdominal cramping. Constipation has also been reported.

Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy.

Blood: Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.

Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.

CNS: Convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness, and insomnia. Two serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.

Hypersensitivity: urticaria, erythematous rash, flushing, nasal congestion, dryness of mouth (or vagina or vulva), and fever.

Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.

Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness.” If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported. Crohn's disease patients are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn's disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Rare cases of pancreatitis, which abated on withdrawal of the drug, have been reported.

The following adverse reactions from the labeling for tetracycline hydrochloride are provided for information.

Gastrointestinal: Anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Rare instances of esophagitis and esophageal ulceration have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of the patients who experienced esophageal irritation took the medication immediately before going to bed.

Liver: Hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment. Increases in liver enzymes and hepatic toxicity have been reported rarely.

Teeth: Permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported.

Blood: hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.

CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. Dizziness, tinnitus, and visual disturbances have been reported. Myasthenic syndrome has been reported rarely.

Hypersensitivity: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and serum sickness-like reactions, as fever, rash, and arthralgia.

Renal: Rise in BUN has been reported and is apparently dose related..

Skin: Maculopapular and erythematous rashes have been reported. Exfoliative dermatitis has been rarely reported. Photosensitivity, onycholysis, and discoloration of the nails have been reported rarely.

Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur.

Side Effects by Body System

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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