What Is Prevacid?
Prevacid (lansoprazole) is a proton pump inhibitor (PPI) used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Prevacid is available in generic form.
What Are Side Effects of Prevacid?
Side effects of Prevacid include headache, nausea, diarrhea, stomach pain, or constipation. Contact your doctor if you experience serious side effects of Prevacid including:
- fast or irregular heart rate,
- watery or bloody diarrhea,
- muscle cramps or weakness,
- jerky muscle movements,
- feeling jittery, or
Dosage for Prevacid
The dose of Prevacid depends on the condition being treated. Lansoprazole capsules should be taken before meals for maximum effect. Capsules should be swallowed whole and should not be crushed, split or chewed.
What Drugs, Substances, or Supplements Interact with Prevacid?
Prevacid may interact with sucralfate, ampicillin, atazanavir, digoxin, iron, ketoconazole, methotrexate, theophylline, blood thinners, or diuretics (water pills). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Prevacid.
Prevacid During Pregnancy and Breastfeeding
Prevacid is not expected to be harmful to a fetus. It is unknown if Prevacid passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Prevacid Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- new or unusual pain in your wrist, back, hip, or thigh;
- a seizure (convulsions);
- kidney problems--fever, nausea, little or no urination, blood in your urine, swelling, rapid weight gain;
- low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
- new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.
Taking lansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.
If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.
Common side effects may include:
- nausea, stomach pain;
- diarrhea, constipation; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Bone Fracture [see WARNINGS AND PRECAUTIONS]
- Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
- Cyanocobalamin (Vitamin B12) Deficiency [see WARNINGS AND PRECAUTIONS]
- Hypomagnesemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
- Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.
The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 1.
Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled PREVACID Studies
|Body System/ Adverse Reaction||PREVACID
|Body as a Whole|
Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9, 1.4, 4.2, and 7.4%, respectively).
The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.
In the risk reduction study of PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, misoprostol, and placebo was 5, 22, and 3%, respectively.
Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with PREVACID included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.
Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:
Body as a Whole - abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain
Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation
Digestive System - abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis
Endocrine System - diabetes mellitus, goiter, hypothyroidism Hemic and Lymphatic System - anemia, hemolysis, lymphadenopathy
Metabolism and Nutritional Disorders - avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss
Musculoskeletal System - arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis
Nervous System - abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo
Respiratory System - asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor
Skin and Appendages - acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria
Special Senses - abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect
Urogenital System - abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis
Additional adverse experiences have been reported since PREVACID and PREVACID SoluTab have been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID or PREVACID SoluTab has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.
Body as a Whole - anaphylactic/anaphylactoid reactions, systemic lupus erythematosus;
Digestive System - hepatotoxicity, pancreatitis, vomiting;
Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura;
Infections and Infestations - Clostridium difficile-associated diarrhea;
Metabolism and Nutritional Disorders - hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia;
Musculoskeletal System - bone fracture, myositis;
Skin and Appendages - severe dermatologic reactions including erythema multiforme, SJS/TEN (some fatal), DRESS, AGEP, cutaneous lupus erythematosus;
Special Senses - speech disorder;
Urogenital System - interstitial nephritis, urinary retention.
Combination Therapy With Amoxicillin And Clarithromycin
In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or clarithromycin.
Triple Therapy: PREVACID/amoxicillin/clarithromycin
The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10 and 14 day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
Dual Therapy: PREVACID/amoxicillin
The most frequently reported adverse reactions for patients who received PREVACID three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with PREVACID three times daily plus amoxicillin three times daily dual therapy than with PREVACID alone.
For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Adverse Reactions section of their prescribing information.
The following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions:
Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.
In the placebo-controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study.
In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.
For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Adverse Reactions section of their prescribing information.
Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PREVACID or PREVACID SoluTab and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 2: Clinically Relevant Interactions Affecting Drugs Coadministered with PREVACID or PREVACID SoluTab and Interactions with Diagnostics
|Clinical Impact:||The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
|Intervention:||Rilpivirine-containing products: Concomitant use with PREVACID or PREVACID SoluTab is contraindicated [see CONTRAINDICATIONS]. See prescribing information.
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with PREVACID or PREVACID SoluTab. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities.
Other antiretrovirals: See prescribing information.
|Clinical Impact:||Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.|
|Intervention:||Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.|
|Clinical Impact:||Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see WARNINGS AND PRECAUTIONS].|
|Intervention:||A temporary withdrawal of PREVACID or PREVACID SoluTab may be considered in some patients receiving high-dose methotrexate.|
|Clinical Impact:||Potential for increased exposure of digoxin.|
|Intervention:||Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.|
|Clinical Impact:||Increased clearance of theophylline [see CLINICAL PHARMACOLOGY ].|
|Intervention:||Individual patients may require additional titration of their theophylline dosage when PREVaCiD or PREVACID SoluTab is started or stopped to ensure clinically effective blood concentrations.|
|Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)|
|Clinical Impact:||Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.|
|Intervention:||Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PREVACID and MMF. Use PREVACID and PREVACID SoluTab with caution in transplant patients receiving MMF.
See the prescribing information for other drugs dependent on gastric pH for absorption.
|Combination Therapy with Clarithromycin and Amoxicillin|
|Clinical Impact:||Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions.|
|Clinical Impact:||Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.|
|Intervention:||Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.|
|Interactions with Investigations of Neuroendocrine Tumors|
|Clinical Impact:||CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].|
|Intervention:||Temporarily stop PREVACID or PREVACID SoluTab treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.|
|Interaction with Secretin Stimulation Test|
|Clinical Impact:||Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.|
|Intervention:||Temporarily stop PREVACID or PREVACID SoluTab treatment at least 28 days before assessing to allow gastrin levels to return to baseline [see CLINICAL PHARMACOLOGY].|
|False Positive Urine Tests for THC|
|Clinical Impact:||There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.|
|Intervention:||An alternative confirmatory method should be considered to verify positive results.|
Table 3: Clinically Relevant Interactions Affecting PREVACID or PREVACID SoluTab When Coadministered with Other Drugs
|CYP2C19 OR CYP3A4 Inducers|
|Clinical Impact:||Decreased exposure of lansoprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY].|
|Intervention:||St John’s Wort, rifampin: Avoid concomitant use with PREVACID or PREVACID SoluTab. Ritonavir-containing products: See prescribing information.|
|CYP2C19 or CYP3A4 Inhibitors|
|Clinical Impact:||Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors [see CLINICAL PHARMACOLOGY].|
|Intervention:||Voriconazole: See prescribing information.|
|Clinical Impact:||Decreased and delayed absorption of lansoprazole [see CLINICAL PHARMACOLOGY].|
|Intervention:||Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate [see DOSAGE AND ADMINISTRATION].|
Read the entire FDA prescribing information for Prevacid (Lansoprazole)
© Prevacid Patient Information is supplied by Cerner Multum, Inc. and Prevacid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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