Prevacid NapraPAC 375 Side Effects

Generic Name: lansoprazole / naproxen

Note: This document contains side effect information about lansoprazole / naproxen. Some of the dosage forms listed on this page may not apply to the brand name Prevacid NapraPAC 375.

Some side effects of Prevacid NapraPAC 375 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lansoprazole / naproxen: oral capsule delayed release, oral tablet

Along with its needed effects, lansoprazole / naproxen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lansoprazole / naproxen:

More common
  • Abdominal or stomach pain, cramping, or burning
  • black, tarry stools
  • bruising
  • constipation
  • diarrhea
  • difficult or labored breathing
  • heartburn
  • indigestion
  • large, flat, blue, or purplish patches in the skin
  • nausea
  • pale skin
  • shortness of breath
  • skin blisters
  • swelling
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
Less common
  • Irregular heartbeat
  • pinpoint red or purple spots on the skin
  • sweating
  • thirst
Rare
  • Abdominal or stomach fullness
  • abdominal or stomach pain with gas
  • ankle, knee, or great toe joint pain
  • anxiety
  • arm, back, or jaw pain
  • back, leg, or stomach pains
  • bladder pain
  • bleeding from rectum or bloody stools
  • bleeding gums
  • blistering, burning, crusting, dryness, or flaking of the skin
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • bloody nose
  • bloody or cloudy urine
  • blue lips and fingernails
  • blurred vision
  • body aches or pain
  • burning while urinating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • change in consciousness
  • changes in menstrual periods
  • chest pain, discomfort, or burning
  • chest tightness or heaviness
  • clay-colored stools
  • cold, clammy skin
  • cold sweats
  • confusion
  • congestion
  • cool, pale skin
  • cough increased
  • cough or hoarseness
  • cough producing mucus
  • coughing or spitting up blood
  • coughing that sometimes produces a pink frothy sputum
  • cracks in the skin
  • dark-colored urine
  • decrease in the amount of urine
  • decreased frequency or amount of urine
  • decreased sexual ability in males
  • decreased urination
  • decreased urine output
  • depression
  • difficult or troubled breathing
  • difficult, burning, or painful urination
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • difficulty with swallowing
  • dilated neck veins
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • dry cough
  • dry mouth
  • dry skin and hair
  • dry, puffy skin
  • dryness or soreness of the throat
  • extreme fatigue
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fast, weak pulse feeling
  • feeling of warmth or heat
  • fever with or without chills
  • fluid-filled skin blisters
  • flushed, dry skin
  • flushing or redness of the skin, especially on the face and neck
  • frequent strong or increased urge to urinate
  • frequent urge to defecate or urinate
  • fruit-like breath odor
  • general body swelling
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • greatly decreased frequency of urination or amount of urine
  • hair loss
  • headache
  • high blood pressure
  • high fever
  • hives
  • inability to speak
  • increase in heart rate
  • increased blood pressure
  • increased clear or white vaginal discharge
  • increased hunger
  • increased need to urinate
  • increased sweating
  • increased thirst
  • increased urination
  • irregular, fast or slow, or shallow breathing
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • joint or muscle pain
  • joint stiffness or swelling
  • kidney pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • loss of consciousness
  • loss of heat from the body
  • lower back or side pain
  • muscle cramps and stiffness
  • neck pain
  • nervousness
  • nightmares
  • noisy breathing
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pain
  • pain in the ankles or knees
  • pain in the groin or genitals
  • pain or burning in the throat
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or tenderness around the eyes and cheekbones
  • pain with swallowing
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • passing of gas
  • passing urine more often
  • pounding in the ears
  • rapid weight gain
  • rapid, shallow breathing
  • rash
  • rectal bleeding
  • recurrent fever
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • redness, soreness, or itching skin
  • runny nose
  • scaly skin
  • seizures
  • sensitivity to the sun
  • severe and continuing nausea
  • severe or continuing stomach pain
  • severe or sudden headache
  • severe stomach pain, cramping, or burning
  • shakiness in the legs, arms, hands, or feet
  • sharp back pain just below ribs
  • shivering
  • skin thinness
  • slurred speech
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sores, welting, or blisters
  • stiff neck or back
  • stomach pain, continuing
  • stomach pain, fullness, or discomfort
  • straining while passing stool
  • sudden decrease in amount of urine
  • sunken eyes
  • swelling of the face, fingers, feet, or lower legs
  • swelling of the front part of the neck
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • temporary blindness
  • tenderness
  • thirst
  • tiredness
  • trouble with sleeping
  • trouble with swallowing
  • troubled breathing with exertion
  • unexplained bleeding or bruising
  • unexplained weight loss
  • unpleasant breath odor
  • unusual weight gain or loss
  • upper right abdominal pain
  • voice changes
  • vomiting
  • watery or bloody diarrhea
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weakness or heaviness of the legs
  • weight gain or loss
  • wrinkled skin
  • yellow eyes and skin
Incidence not known
  • Change in mental status
  • clay colored stools
  • decrease in frequency of urination
  • decreased appetite
  • difficulty in passing urine (dribbling)
  • difficulty with speaking
  • difficulty with swallowing
  • greatly decreased frequency of urination or amount of urine
  • nosebleeds
  • pains in the stomach, side, or abdomen, possibly radiating to the back

Some side effects of lansoprazole / naproxen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Absent missed or irregular menstrual periods
  • belching
  • continuing ringing or buzzing or other unexplained noise in the ears
  • excess air or gas in the stomach or intestines
  • hearing loss
  • pain in the chest below the breastbone
  • passing gas
  • sleepiness
  • stopping of menstrual bleeding
Less common
  • Acid or sour stomach
  • change in hearing
  • disturbed color perception
  • double vision
  • feeling of constant movement of self or surroundings
  • loss of hearing
  • night blindness
  • overbright appearance of lights
  • seeing halos around lights
  • sensation of spinning
  • swelling or inflammation of the mouth
  • tunnel vision
Rare
  • Abnormal dreams
  • abnormal menses
  • abnormal stools
  • bad breath
  • blemishes on the skin
  • bone deformity
  • breast enlargement, pain, or tenderness
  • breath odor
  • burning feeling in the chest or stomach
  • burning, dry, or itching eyes
  • change in ability to see colors, especially blue or yellow
  • change in color vision
  • change in hearing
  • changes in vision
  • cold sweats
  • coma
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • cramps
  • crying
  • deafness
  • decrease in height
  • decrease or change in vision
  • decreased interest in sexual intercourse
  • decreased vision
  • depersonalization
  • difficulty seeing at night
  • discharge, excessive tearing
  • discoloration of the fingernails or toenails
  • discouragement
  • double vision
  • drooping upper eyelids
  • dysphoria
  • earache
  • enlarged abdomen
  • euphoria
  • excessive muscle tone
  • eye pain
  • fear
  • fecal discoloration
  • feeling of constant movement of self or surroundings
  • feeling of unreality
  • feeling sad or empty
  • fruit-like breath odor
  • hair loss or thinning of the hair
  • headache, severe and throbbing
  • heavy bleeding
  • hiccup
  • hostility
  • hyperventilation
  • impaired vision
  • inability to concentrate
  • inability to have or keep an erection
  • inability to move the legs or arms
  • increase in body movements
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased salivation
  • increased sensitivity of the skin to sunlight
  • irritability
  • itching of the vagina or genital area
  • lack of appetite
  • lack of feeling or emotion
  • lack or loss of strength
  • leg cramps
  • longer or heavier menstrual periods
  • loss of interest or pleasure
  • loss of memory
  • loss of strength or energy
  • mood or mental changes
  • mouth ulceration
  • muscle aching or cramping
  • muscle or bone pain
  • muscle tension or tightness
  • muscle weakness
  • neck pain or rigidity
  • nightmares
  • pain during sexual intercourse
  • pain in the back, ribs, arms, or legs
  • paralysis of one side of the body
  • paranoia
  • passing gas
  • pelvic pain
  • persistent non-healing sore
  • pimples
  • poor insight and judgment
  • problems with memory or speech
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash with flat lesions or small raised lesions on the skin
  • red-green color blindness
  • reddish patch or irritated area
  • redness or other discoloration of the skin
  • redness or swelling in the arms or legs
  • redness or swelling in the ear
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • redness, swelling, or soreness of the tongue
  • restlessness
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sensation of spinning
  • sense of detachment from self or body
  • severe sunburn
  • shiny bump
  • skin disorder
  • sleep disorder
  • swelling of the breasts or breast soreness in both females and males
  • swelling or inflammation of the mouth
  • taste loss
  • tearing
  • thick, white vaginal discharge with no odor or with a mild odor
  • tiredness
  • transient, mild, pleasant aromatic odor
  • trouble performing routine tasks, recognizing objects, thinking and planning, or walking
  • uncaring
  • unexplained weight loss
  • urethral pain
  • white patches with diaper rash
  • white, yellow, or waxy scar-like area

For Healthcare Professionals

Applies to lansoprazole / naproxen: oral kit

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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