Side Effects of Prevacid (lansoprazole)

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). 

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. 

Prevacid may increase blood levels of methotrexate and tacrolimus. 

Proton pump inhibitors may also increase the action of warfarin, increasing the risk of bleeding. 

Use of Prevacid in pregnant women has not been adequately evaluated. Prevacid has not been studied in nursing women. Consult your doctor before breastfeeding.

What are the common side effects of Prevacid?

Common side effects of Prevacid include

• diarrhea,
• nausea,
• vomiting,
• constipation,
• rash,
• headaches,
• dizziness,
• nervousness,
• abnormal heartbeat,
• muscle pain,
• weakness,
• leg cramps, and
• water retention.

What are the serious side effects of Prevacid?

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.

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

Table 3. Clinically Relevant Interactions Affecting Prevacid or Prevacid SoluTab When Co-Administered with Other Drugs

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
• Hypomagnesemia

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

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

Postmarketing Experience

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; Musculoskeletal System – bone fracture, myositis;

Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), 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.

Laboratory Values

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.