Prevacid SoluTab 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 SoluTab.

Some side effects of 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.

For the Consumer

Applies to lansoprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet disintegrating delayed release

Along with its needed effects, lansoprazole (the active ingredient contained in Prevacid SoluTab) 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 lansoprazole:

More common
  • Diarrhea
  • skin rash or itching
Less common
  • Abdominal or stomach pain
  • increased or decreased appetite
  • joint pain
  • nausea
  • vomiting
Rare
  • Anxiety
  • cold or flu-like symptoms
  • constipation
  • increased cough
  • mental depression
  • muscle pain
  • rectal bleeding
  • unusual bleeding or bruising
Incidence not known
  • Abdominal or stomach tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody, black, or tarry stools
  • change in mental status
  • chest pain
  • chills
  • clay colored stools
  • cough or hoarseness
  • dark or bloody urine
  • difficulty with swallowing
  • drowsiness
  • fast heartbeat
  • fever
  • general body swelling
  • high fever
  • hives
  • indigestion
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle spasms (tetany) or twitching seizures
  • nosebleeds
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • seizures
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen or painful glands
  • tightness in the chest
  • trembling
  • unusual tiredness or weakness
  • wheezing
  • yellowing of the eyes or skin

Some side effects of lansoprazole 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
  • Dizziness
  • headache
Less common
  • Bleeding, blistering, burning, coldness, or discoloration of the skin
  • mild nausea
Rare
  • Acid or sour stomach
  • bad, unusual or unpleasant (after) taste
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • feeling faint, dizzy, or lightheaded
  • feeling of heat or warmth
  • flushing or redness of the skin, especially on the face and neck
  • heartburn
  • indigestion
  • mild diarrhea
  • mild headache
  • mild vomiting
  • stomach discomfort, upset, or pain
  • sweating
Incidence not known
  • Decrease in passing urine (dribbling)
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty with speaking

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 SoluTab) 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 SoluTab) 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 SoluTab) 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 SoluTab) 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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