Prevacid OTC Side Effects

Generic name: lansoprazole

Note: This document contains side effect information about lansoprazole. Some of the dosage forms listed on this page may not apply to the brand name Prevacid OTC.

Some side effects of Prevacid OTC 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 lansoprazole: oral delayed release capsule, oral suspension, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking lansoprazole (the active ingredient contained in Prevacid OTC) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using lansoprazole and call your doctor at once if you have symptoms of low magnesium:

• dizziness, confusion;

• fast or uneven heart rate;

• jerky muscle movements;

• feeling jittery;

• diarrhea that is watery or bloody;

• muscle cramps, muscle weakness or limp feeling;

• cough or choking feeling; or

• seizure.

Less serious side effects of lansoprazole may include:

• headache;

• nausea, stomach pain;

• mild diarrhea; or

• constipation.

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 lansoprazole: compounding powder, intravenous powder for injection, oral delayed release capsule, oral granule for reconstitution, oral suspension, oral tablet disintegrating

Oncologic

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 (the active ingredient contained in Prevacid OTC) 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

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.

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.

Nervous system

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.

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

Dermatologic

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

Hepatic

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 (the active ingredient contained in Prevacid OTC) Hepatotoxicity has also been reported in postmarketing experience.

Respiratory

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

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

Genitourinary

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

Cardiovascular side effects have been reported rarely. These have included angina, myocardial infarction, hypertension, and hypotension in patients taking lansoprazole (the active ingredient contained in Prevacid OTC) 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

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

Musculoskeletal side effects have included muscle spasm (tetany), arthralgia, aggravation of arthritis, arthropathy, cramps, fibromyalgia syndrome, hernia, hypertonia, polymyalgia rheumatica, and back pain. Myalgia and bone fracture have also been reported.

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.

Hematologic

An 85-year-old man experienced thrombocytopenia after receiving a second dose of lansoprazole (the active ingredient contained in Prevacid OTC) 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.

Other

Other side effects including increased blood potassium, increased blood urea, crystal urine present, and positive fecal occult blood have been reported.

Metabolic

FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.

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