Does Prevacid (lansoprazole) cause side effects?
Prevacid (lansoprazole) is a proton pump inhibitor (PPI) which blocks the production of acid by the stomach used to treat conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome that are caused by stomach acid.
Prevacid, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Prevacid is available over-the-counter (OTC).
Common side effects of Prevacid include
- abnormal heartbeat,
- muscle pain,
- leg cramps, and
- water retention.
Serious side effects of Prevacid include
- increased risk of Clostridium difficile infection;
- increased risk of osteoporosis-related fractures of the hip, wrist, or spine with high doses and long-term use (1 year or longer);
- reduced absorption of vitamin B12 (cyanocobalamin);
- low levels of magnesium (hypomagnesemia) with long-term use; and
- increased risk of heart attacks with long-term use.
Drug interactions of Prevacid include other drugs whose absorption may be affected by stomach acidity. Prevacid and other PPIs that reduce stomach acid also reduce the absorption and concentration in blood of ketoconazole and increase the absorption and concentration in blood of digoxin. This may lead to reduced effectiveness of ketoconazole or increased digoxin toxicity, respectively.
What are the important side effects of Prevacid (lansoprazole)?
Lansoprazole like other PPIs is well-tolerated. The most common side effects are:
Other important side effects include:
Proton pump inhibitors may increase the risk of Clostridium difficile infection. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Prolonged use also reduces absorption of vitamin B12 (cyanocobalamin).
Long-term use of PPIs has also been associated with low levels of magnesium (hypomagnesemia). Analysis of patients taking PPIs for long periods of time showed an increased risk of heart attacks.
Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
Prevacid (lansoprazole) side effects list for healthcare professionals
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Interstitial Nephritis
- Clostridium difficile-Associated Diarrhea
- Bone Fracture
- Cutaneous and Systemic Lupus Erythematosus
- Cyanocobalamin (Vitamin B12) Deficiency
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 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.
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
- epigastric discomfort,
- esophageal disorder,
- hiatal hernia,
- 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
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;
Infections and Infestations – Clostridium difficile-associated diarrhea;
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.
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.
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,
- blood potassium increased,
- blood urea increased,
- crystal urine present,
- hemoglobin decreased,
- increased/decreased electrolytes,
- increased/decreased cholesterol,
- increased glucocorticoids,
- increased LDH,
- increased/decreased/abnormal platelets,
- increased gastrin levels and
- positive fecal occult blood.
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.
What drugs interact with Prevacid (lansoprazole)?
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 Co-Administered with
Prevacid orPrevacid 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.
Rilpivirine-containing products: Concomitant use with Prevacid or Prevacid SoluTab is contraindicated. 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.|
|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.|
|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.|
Mycophenolate mofetil (MMF): Co-administration 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.|
|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.|
|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 Co-Administered with Other Drugs
|CYP2C19 OR CYP3A4 Inducers|
|Clinical Impact:||Decreased exposure of lansoprazole when used concomitantly with strong inducers.|
|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.|
|Intervention:||Voriconazole: See prescribing information.|
|Clinical Impact:||Decreased and delayed absorption of lansoprazole.|
|Intervention:||Take Prevacid or Prevacid SoluTab at least 30 minutes prior to sucralfate.|
Prevacid (lansoprazole) is a proton pump inhibitor (PPI) which blocks the production of acid by the stomach used to treat conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome that are caused by stomach acid. Common side effects of Prevacid include diarrhea, nausea, vomiting, constipation, rash, headaches, dizziness, nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, and water retention. Use of Prevacid in pregnant women has not been adequately evaluated. Prevacid has not been studied in nursing women. Consult your doctor before breastfeeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.