Prevacid SoluTab Side Effects

Generic name: lansoprazole

Generic Name: Lansoprazole

Please note - some side effects for Prevacid SoluTab 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 Prevacid SoluTab - for the consumer

Prevacid SoluTab Orally Disintegrating Tablets

All medicines may 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 Prevacid SoluTab Orally Disintegrating Tablets:

Constipation; diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizure; unusual bruising or bleeding; unusual tiredness; vision changes.

By body system

Oncologic side effects

Oncologic side effects have not been reported in humans. Drugs which increase gastric pH would be anticipated to stimulate release of gastrin. Animal studies have demonstrated an increase in plasma gastrin concentrations following the administration of lansoprazole. In addition, lifelong high-dose animal studies have revealed a dose-related increase in the incidence of gastric enterochromaffin-like (ECL) cell carcinoids (especially in female rats). However, to date, human studies of up to 1 year have not found any suggestion of gastric carcinoid formation due to lansoprazole use.

Gastrointestinal side effects

Gastrointestinal side effects have included diarrhea (3.2% to 11.6%), abdominal pain (1.8% to 4.3%), and nausea (1.4%). Vomiting and constipation have been reported less often. At least 6 cases of microscopic colitis have been reported. Pancreatitis has also been reported during postmarketing experience.

Case series report of lansoprazole-associated microscopic colitis was confirmed by pathology studies of random biopsies of colon in six patients who developed chronic watery diarrhea. Patients completely recovered within 4 to 10 days after discontinuation of therapy.

Nervous system side effects

The manufacturer reports that headache occurs more often in placebo treated patients than in lansoprazole treated patients.

Nervous system side effects have included headache in as many as 23% of patients (although most investigators have reported a much lower incidence), dizziness, and pain. Speech disorder has also been reported during postmarketing experience.

Dermatologic side effects

Dermatologic side effects have included skin rash in 4.3% of patients. Rarely, erythema multiforme has been reported.

Hepatic side effects

Hepatic side effects have included elevations of gamma-glutamyltransferase (GGT) and other liver function tests in a small number of patients. Elevated alanine aminotransferase (ALT) levels have been reported within a month after initiation of treatment with lansoprazole. Hepatotoxicity has also been reported in postmarketing experience.

Respiratory side effects

Respiratory side effects have included rhinitis and pharyngitis in 1% to 2% of patients. Cough and influenza-like symptoms have been reported less frequently.

Psychiatric side effects

Psychiatric side effects including depression and anxiety have been extremely uncommon.

Genitourinary side effects

Genitourinary side effects have been reported rarely. Impotence has been reported in some patients and a poorly described "testes disorder" has been reported in one patient. Interstitial nephritis and urinary retention have also been reported in postmarketing experience.

Cardiovascular side effects

Cardiovascular side effects have been reported rarely. These have included angina, myocardial infarction, hypertension, and hypotension in patients taking lansoprazole but the etiology of these cardiovascular problems was not specifically attributed to lansoprazole. Necrotizing arteritis has been reported in dogs. However, the clinical implications for human use have not been determined. In humans, one case of ischemic optic neuropathy has been tentatively associated with the use of the related drug omeprazole.

Hypersensitivity side effects

Hypersensitivity side effects have rarely included toxic epidermal necrolysis. A few cases of eosinophilia have been reported and a single case of glottis edema. Stevens-Johnson syndrome and anaphylactic/anaphylactoid reactions have also been reported during postmarketing experience.

Musculoskeletal side effects

An increased risk of hip fracture has been reported in a recent cohort study with information on patients in the United Kingdom (1987 to 2003). The risk of hip fracture was significantly increased among patients prescribed long-term high dose PPIs.

A 50-year-old white woman developed severe myalgia one week after starting lansoprazole. The patient also was found to have eosinophilia. The severity of pain worsened to the point where she had to quit her job and could not sleep at night. The patient eventually recovered after stopping lansoprazole and being treated with prednisone.

A 46-year-old woman who had undergone near total thyroidectomy six years earlier and fully compliant with her thyroid medication was diagnosed with tetany coincident with lansoprazole therapy. She had undergone two weeks of treatment with lansoprazole 30 mg daily. Her signs and symptoms responded immediately to intravenous administration of 10% calcium gluconate (20 mL) over 20 minutes; oral calcium carbonate, 2 g; and 0.25 mg calcitriol, and she fully recovered. Hypocalcemia is known to occur in subtotal thyroidectomy and in achlorhydria.

Musculoskeletal side effects have been reported rarely. Hip fracture has been reported, in addition to at least one case of tetany. Myositis has also been reported during postmarketing experience.

Hematologic side effects

An 85-year-old man experienced thrombocytopenia after receiving a second dose of lansoprazole 60 mg while in the hospital. His platelet count returned to normal values a few days after the drug was discontinued.

Hematologic side effects have included decreased hemoglobin. Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombocytopenic purpura have been reported during postmarketing experience.

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