Prevacid Side Effects

Generic Name: lansoprazole

Please note - some side effects for Prevacid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prevacid - for the Consumer

Prevacid I.V.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevacid I.V.:

Constipation; diarrhea; headache; nausea; pain, swelling, or redness at the injection site; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizure; unusual bruising or bleeding; unusual tiredness; vision changes.

Prevacid Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevacid Delayed-Release Capsules:

Constipation; diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizure; unusual bruising or bleeding; unusual tiredness; vision changes.

Prevacid NapraPAC Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevacid NapraPAC Delayed-Release Capsules:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision, hearing, or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Prevacid SoluTab Orally Disintegrating Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevacid SoluTab Orally Disintegrating Tablets:

Constipation; diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizure; unusual bruising or bleeding; unusual tiredness; vision changes.

Prevacid Powder Packet

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevacid Powder Packet:

Constipation; diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizure; unusual bruising or bleeding; unusual tiredness; vision changes.

Prevacid Side Effects - for the Professional

Prevacid

Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. (6)

Prevacid Injection

Clinical Safety Experience with Prevacid I.V. for Injection

More than 1,000 patients and subjects have participated in domestic and foreign clinical trials. Treatment with Prevacid I.V. for Injection was well-tolerated.

In four U.S. trials involving 161 subjects exposed to Prevacid I.V. for Injection, the following treatment-related adverse events were reported in ≥1% of subjects: headache (1.0%), injection site pain (1.0%), injection site reaction (1.0%) and nausea (1.3%). Treatment-related adverse events occurring in less than 1% of subjects included abdominal pain, vasodilatation, diarrhea, dyspepsia, vomiting, dizziness, paresthesia, rash, and taste perversion. No additional adverse drug reactions were reported with the intravenous formulation that had not been reported previously with the oral formulations.

Clinical Safety Experience with Oral Formulations of Prevacid

Worldwide, over 10,000 patients have been treated with oral 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 events 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 4.

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 mg 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).

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; Metabolic 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

Additional adverse experiences have been reported since oral Prevacid has been marketed. The majority of these cases are foreign-sourced and a relationship to Prevacid has not been established. Because these events 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; Digestive System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal System – myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses - speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Laboratory Values

There were no clinically important changes identified in any laboratory parameter with Prevacid I.V. for Injection.

The following changes in laboratory parameters in patients who received Prevacid were reported as adverse events:

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, eosinophilia, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, and increased gastrin levels. 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.

Side Effects by Body System

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. 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. 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 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 been reported rarely. Hip fracture has been reported, in addition to at least one case of tetany. Myositis has also been reported during postmarketing experience.

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 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.

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