Prevacid NapraPAC Side Effects

Please note - some side effects for Prevacid NapraPAC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Prevacid NapraPAC - for the Consumer

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Prevacid NapraPAC Delayed-Release Capsules:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prevacid NapraPAC Side Effects - for the Professional

Prevacid NapraPAC

NAPROSYN

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis in controlled NAPROSYN trials are listed below. In general, reactions in patients treated chronically with NAPROSYN were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the GI tract.

A clinical study found GI reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen.

In controlled clinical naproxen trials with about 80 pediatric patients and in well-monitored, open-label naproxen studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of GI and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

GI Experiences, including: heartburn1, abdominal pain1, nausea1, constipation1, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache1, dizziness1, drowsiness1, lightheadedness, vertigo

Dermatologic: pruritus (itching)1, skin eruptions1, ecchymoses1, sweating, purpura

Special Senses: tinnitus1, visual disturbances, hearing disturbances

Cardiovascular: edema1, palpitations

General: dyspnea1, thirst

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

GI Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in less than 1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

GI: GI bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), nonpeptic GI ulceration, ulcerative stomatitis, esophagitis, peptic ulceration

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in less than 1% of patients:

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

GI: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria

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1

Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

PREVACID

Clinical

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. The adverse reaction profiles for PREVACID Delayed-Release Capsules and PREVACID for Delayed-Release Oral Suspension are similar. 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.

Table 4: Incidence of Possibly or Probably Treatment-Related Adverse Events in Short-Term, Placebo-Controlled PREVACID Studies
Body System/Adverse Event	PREVACID (N= 2768) %	Placebo (N= 1023) %
Body as a Whole
Abdominal Pain	2.1	1.2
Digestive System
Constipation	1.0	0.4
Diarrhea	3.8	2.3
Nausea	1.3	1.2

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).

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 events 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, GI anomaly, GI disorder, GI 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 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

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, 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 of 978) and 0.4% (11 of 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.

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Side Effects by Body System - for Healthcare Professionals

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).

Cardiovascular side effects associated with naproxen have included peripheral edema (3% to 9%) and palpitations (3%). Blood pressure may be elevated by naproxen, which may have clinical relevance in patients with comorbid illnesses. Cardiovascular side effects reported in less than 1% of patients have included hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction, congestive heart failure, and vasculitis.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk of the initiation of antihypertensive therapy. NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

The cumulative rate of serious cardiovascular thromboembolic adverse events (heart attacks, angina pectoris, and peripheral vascular events) observed in the Vioxx Gastrointestinal Outcomes research (Vigor) study has been reported to occur in a smaller percentage of patients taking naproxen compared to rofecoxib (0.6% vs. 1.8% respectively).

Dermatologic

Excessive sun exposure may play a role in cases of skin eruptions resembling porphyria cutanea tarda. Biochemical evidence of porphyria, such as elevated serum porphyrins, is lacking in these cases. Photosensitivity reactions have also been associated with lesions resembling those of epidermolysis bullosa.

Although rarely reported with the use of naproxen, a 14-year-old girl is diagnosed with periareolar fixed drug eruption after taking naproxen during menses for dysmenorrhea.

Dermatologic side effects associated with lansoprazole have included skin rash in 4.3% of treated patients. Rarely, toxic epidermal necrolysis and erythema multiforme have been reported.

Dermatologic side effects reported in 3% to 9% of patients have included pruritus, skin eruptions, and ecchymoses. Dermatologic side effects associated with naproxen have also included sweating (less than 3%), purpura (less than 3%), exfoliative dermatitis (less than 1%), and rash (1% to 10% or less). Skin eruptions have been reported in patients receiving the controlled release formulation of naproxen. Dermatologic side effects reported in postmarketing experience in less than 1% of patients have included alopecia, erythema multiforme, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.

Gastrointestinal

Gastrointestinal side effects associated with lansoprazole have included diarrhea (in 3.2% to 11.6% of treated patients), abdominal pain (1.8% to 4.3%), and nausea (1.4%). Vomiting and constipation have been reported less often.

Gastrointestinal side effects associated with naproxen have commonly included constipation (3% to 9%), general abdominal discomfort (3% to 9%), nausea (3% to 9%), dyspepsia (less than 3%), diarrhea (less than 3%), stomatitis (less than 3%), flatulence (1% to 10%), bleeding/perforation (1% to 10% or less), vomiting (1% to 10% or less), and GI ulcers (gastric/duodenal) (1% to 10% or less). Gastrointestinal side effects reported in less than 1% of patients have included rectal bleeding, dry mouth, esophagitis, gastritis, glossitis, pancreatitis, and eructation. Serious gastrointestinal side effects have included peptic ulcerations, and, in rare cases, gastrointestinal hemorrhage or perforation. Ulcerative esophagitis, eosinophilic colitis, allergic sialadenitis, and pancreatitis have been reported. Heartburn and stomatitis have been reported in patients receiving the controlled release formulation of naproxen. Gastrointestinal side effects reported in postmarketing experience in less than 1% of patients have included perforation, hematemesis, colitis, nonpeptic GI ulceration, and ulcerative stomatitis.

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.

Because peptic irritation may be asymptomatic, occasional monitoring of the hematocrit and of the stool for occult blood loss is recommended.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Naproxen should be used with caution in these patients.

The combination of naproxen and alendronate has been reported to have a synergistic effect in the development of gastric ulcers.

Genitourinary

Genitourinary side effects associated with lansoprazole have been reported rarely. Impotence has been reported in some patients and a poorly described "testes disorder" has been reported in one patient.

Genitourinary side effects associated with naproxen reported in less than 1% of patients have included dysuria, oliguria, polyuria, and proteinuria. Genitourinary side effects reported in postmarketing experience in less than 1% of patients have included menstrual disorders.

Hematologic

Hematologic side effects reported during the postmarketing phase of lansoprazole have included agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombocytopenic purpura.

Hematologic side effects associated with naproxen have included platelet dysfunction resulting in increased bleeding times (1% to 10%), anemia (1% to 10%), and decreased hematocrit (1% to 2%). Hematologic side effects reported in less than 1% of patients have included neutropenia, thrombocytopenia, agranulocytosis, lymphadenopathy, pancytopenia, and melena. Hematologic side effects reported in postmarketing experience in less than 1% of patients have included eosinophilia, leucopenia, granulocytopenia, hemolytic anemia, and aplastic anemia.

Thrombocytopenia has been reported in an 85-year-old man after the second dose of lansoprazole 60 mg while in the hospital. Platelet count returned to normal values few days after drug was stopped.

Hepatic

Hepatic side effects associated with lansoprazole have included elevations of GGT and other liver function tests in a small number of patients.

Hepatic side effects associated with naproxen have included elevations in liver function tests (1% to 15%), jaundice (less than 1%), and hepatitis (less than 1%).

Elevations in liver function tests three times normal values, for SGOT (AST) and SGPT (ALT), are reported in 0.4 % of patients that participated in the placebo controlled studies for lansoprazole.

Naproxen-induced hepatitis has been associated with a fatal outcome in some cases.

Hypersensitivity

Hypersensitivity side effects associated with lansoprazole have been rarely reported. A few cases of eosinophilia have been reported and a single case of glottis edema.

Hypersensitivity to naproxen is rare, but may result in an erythematous or urticarial rash (less than 1%), Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and bronchospasm, especially in patients with aspirin-sensitive asthma. Anaphylactoid reactions (less than 1%) have been reported as well. Hypersensitivity side effects reported in postmarketing experience reported in less than 1% of patients have included anaphylactoid reactions, angioneurotic edema. Hypersensitivity has been implicated in cases of renal failure, pneumonitis, and colitis.

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.

There have been postmarketing reports of increased risk of bone fracture associated with lansoprazole.

Musculoskeletal side effects associated with naproxen reported in postmarketing experience in less than 1% of patients have included malaise, myalgia, asthenia, and muscle weakness.

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.

Two weeks after treatment with lansoprazole 30 mg daily, a 46-year-old woman, fully compliant with her thyroid medication, was diagnosed with tetany. 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.

Nervous system

Nervous system side effects associated with lansoprazole have included headache in as many as 23% of treated patients (although most investigators have reported a much lower incidence), dizziness, pain, and convulsions.

Nervous system side effects associated with naproxen have included dizziness (3% to 9%), headache (3% to 9%), drowsiness (3% to 9%), lightheadedness (less than 3%), and vertigo (less than 3%). Nervous system side effects reported in 1% of patients have included somnolence, tremors, convulsions, coma, and paresthesia.

The manufacturer reports that headache occurs more often in placebo treated patients than in lansoprazole treated patients.

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.

Immunologic

Immunologic side effects associated with naproxen reported in less than 1% of patients have included infection and sepsis. Immunologic side effects reported in postmarketing experience in less than 1% of patients have included aseptic meningitis and cystitis.

Psychiatric

Psychiatric side effects associated with lansoprazole have been extremely uncommon but may include depression and anxiety.

Psychiatric side effects associated with naproxen reported in less than 1% of patients have included hallucinations, confusion, inability to concentrate, anxiety, and nervousness. Psychiatric side effects associated with naproxen reported in postmarketing experience in less than 1% of patients have included depression, dream abnormalities, insomnia, and cognitive dysfunction.

Respiratory

Several cases of pulmonary infiltration accompanied by eosinophilia have been reported in the literature. Fever, malaise, and respiratory symptoms are typically present. Discontinuation of naproxen results in resolution of symptoms.

Respiratory side effects associated with lansoprazole have included rhinitis and pharyngitis in 1% to 2% of treated patients. Cough and influenza-like symptoms have been reported less frequently. Dyspnea has been reported in patients receiving controlled release naproxen.

Respiratory side effects associated with naproxen patients have included dyspnea (3% to 9%), asthma (less than 1%), respiratory depression (less than 1%), and pneumonia (less than 1%). Respiratory side effects reported in postmarketing experience in less than 1% of patients have included eosinophilic pneumonitis. Several cases of pulmonary infiltration accompanied by eosinophilia have been reported with naproxen. Fever, malaise, and respiratory symptoms are typically present. Discontinuation of naproxen results in resolution of symptoms.

Other

Other side effects associated with naproxen have included tinnitus (3% to 9%), hearing disturbances (less than 3%), thirst (less than 3%), weight changes (less than 1%), appetite changes (less than 1%), fever (less than 1%), and death (less than 1%). Other side effects reported in postmarketing experience in less than 1% of patients have included hearing impairment, and pyrexia (chills and fever).

Renal

Renal side effects associated with lansoprazole have included the development of mild renal insufficiency, nephrotic syndrome (with or without renal failure), acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis. Hypersensitivity may play a role in some cases of renal failure.

Renal side effects associated with naproxen reported in 1% to 10% of patients have included abnormal renal function. Renal side effects reported in postmarketing experience in less than 1% of patients have included glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephritic syndrome, renal disease, renal failure, and renal papillary necrosis. A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Metabolic

Metabolic side associated with naproxen reported in postmarketing in less than 1% of patients have included hyperglycemia and hypoglycemia.

Ocular

Ocular side effects associated with naproxen have included visual disturbances (less than 3%), blurred vision (less than 1%), and conjunctivitis (less than 1%), and keratopathy.

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