Esomeprazole / Naproxen Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 22, 2024.

Applies to esomeprazole / naproxen: oral tablet delayed release.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not use this medicine together with medicines containing rilpivirine (Complera®, Edurant®, Odefsey®). Using these medicines together may cause unwanted side effects.

Naproxen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to your arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.

Naproxen may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you or your child have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

If you or your child are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause kidney problems. Tell your doctor right away if you or your child has blood in the urine, decreased urine output, confusion, dizziness, headache, muscle twitching, rapid weight gain, swelling of your face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Call your doctor right away if you have confusion, nausea or vomiting, weakness or heaviness of the legs, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

Check with your doctor right away if you or your child has a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These could be symptoms of acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have seizures, fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Serious stomach conditions may occur while taking this medicine alone. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may be bloody sometimes, fever, nausea, vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you or your child has joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not Stop taking esomeprazole / naproxen without first checking with your doctor, or unless told to do so by your doctor.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Serious side effects

Along with its needed effects, esomeprazole / 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 esomeprazole / naproxen:

Other side effects

Some side effects of esomeprazole / 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:

For healthcare professionals

Applies to esomeprazole / naproxen: oral delayed release tablet.

General adverse events

Naproxen:

• Postmarketing reports: Anaphylactic reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever), hearing impairment^[Ref]

Gastrointestinal

Esomeprazole-naproxen:

• Very common (10% or more): Gastritis erosive (up to 38%), dyspepsia (up to 27%), gastritis (up to 17%)
• Common (1% to 10%): Diarrhea, gastric ulcer, upper abdominal pain, nausea, hiatus hernia, abdominal distension, flatulence, esophagitis, constipation, abdominal pain, duodenitis, erosive duodenitis, lower abdominal pain, hemorrhagic gastritis, gastroesophageal reflux disease, duodenal ulcer, erosive esophagitis
• Postmarketing reports: Hematochezia

Esomeprazole:

• Postmarketing reports: Pancreatitis; stomatitis; microscopic colitis, GI candidiasis, Clostridium difficile associated diarrhea
• Uncommon (0.1% to 1%): Dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting, abdomen enlarged, Clostridium difficile associated diarrhea

Naproxen:

• Common (1% to 10%): Heartburn, nausea, dyspepsia, stomatitis
• Uncommon (0.1% to 1%): Pancreatitis, melena
• Postmarketing reports: Inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, and obstruction of the upper or lower gastrointestinal tract, esophagitis, stomatitis, hematemesis, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)^[Ref]

Esomeprazole-naproxen was reported to cause fewer NSAID-related upper gastrointestinal adverse events (e.g., duodenal ulcer) (53.3%) compared to enteric coated naproxen taken as monotherapy (70.4%).

NSAIDs, including naproxen, have been reported to lead to upper gastrointestinal ulcers and gross bleeding or perforation in approximately 1% of patient treated for 3 to 6 months, and about 2% to 4% of patients treated for one year.^[Ref]

Genitourinary

Esomeprazole-naproxen:

• Common (1% to 10%): Urinary tract infection

Esomeprazole:

• Uncommon (0.1% to 1%): Vaginitis, cystitis, dysuria, fungal infection, micturition frequency, moniliasis, genital moniliasis^[Ref]

Respiratory

Esomeprazole-naproxen:

• Common (1% to 10%): Upper respiratory tract infection, bronchitis, sinusitis
• Uncommon (0.1% to 1%): Nasopharyngitis, cough

Esomeprazole:

• Uncommon (0.1% to 1%): Chest pain, substernal chest pain, asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis
• Postmarketing reports: Bronchospasm

Naproxen:

• Common (1% to 10%): Dyspnea
• Postmarketing reports: Eosinophilic pneumonitis, asthma^[Ref]

Musculoskeletal

Esomeprazole-naproxen:

• Common (1% to 10%): Arthralgia
• Postmarketing reports: Joint swelling, muscle spasms

Esomeprazole:

• Uncommon (0.1% to 1%): Arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica, back pain
• Postmarketing reports: Muscular weakness, myalgia, bone fracture

Naproxen:

• Postmarketing reports: Myalgia, muscle weakness^[Ref]

Cardiovascular

Esomeprazole-naproxen:

• Frequency not reported: Peripheral edema, arrhythmia, palpitations, myocardial infarction, congestive heart failure, hypertension, syncope

Esomeprazole:

• Uncommon (0.1% to 1%): Flushing, hypertension, tachycardia

Naproxen:

• Common (1% to 10%): Palpitations
• Postmarketing reports: Congestive heart failure, vasculitis, hypertension, pulmonary edema^[Ref]

Clinical trials and epidemiological data have suggested a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) with the use of "coxibs" or some NSAIDs, especially when used at high doses and for long treatment durations. Although naproxen doses of 1000 mg per day may be associated with a lower risk than COX-2 selective inhibitors, a small risk cannot be excluded.^[Ref]

Other

Esomeprazole-naproxen:

• Postmarketing reports: Gait disturbances

Esomeprazole:

• Uncommon (0.1% to 1%): Fatigue, fever, flu-like disorder, generalized edema, , malaise, pain, rigors, earache, tinnitus, vertigo, asthenia, dysmenorrhea, menstrual disorder, hot flushes
• Postmarketing reports: GI candidiasis, gynecomastia

Naproxen:

• Common (1% to 10%): Vertigo, tinnitus, hearing disturbances, thirst
• Postmarketing reports: Angioneurotic edema, menstrual disorders, hearing impairment, infertility, papillitis, malaise, aseptic meningitis^[Ref]

Renal

Esomeprazole-naproxen:

• Postmarketing reports: Renal tubular necrosis

Esomeprazole:

• Uncommon (0.1% to 1%): Abnormal urine, albuminuria, hematuria, polyuria, glycosuria, hyperuricemia
• Postmarketing reports: Interstitial nephritis

Naproxen:

• Postmarketing reports: Glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine^[Ref]

Dermatologic

Esomeprazole:

• Uncommon (0.1% to 1%): Acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria, facial edema
• Postmarketing reports: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Naproxen:

• Common (1% to 10%): Pruritus, skin eruptions, ecchymoses, sweating, purpura
• Uncommon (0.1% to 1%): Skin rashes
• Postmarketing reports: Alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa^[Ref]

Endocrine

Esomeprazole:

• Uncommon (0.1% to 1%): Goiter^[Ref]

Hematologic

Esomeprazole:

• Uncommon (0.1% to 1%): Anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia
• Postmarketing reports: Agranulocytosis, pancytopenia

Naproxen:

• Uncommon (0.1% to 1%): Thrombocytopenia, agranulocytosis
• Postmarketing reports: Eosinophilia, leukopenia, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia^[Ref]

Hepatic

Esomeprazole:

• Uncommon (0.1% to 1%): Bilirubinemia, abnormal hepatic function, SGOT increased, SGPT increased
• Postmarketing reports: Hepatic failure, hepatitis with or without jaundice

Naproxen:

• Uncommon (0.1% to 1%): Jaundice
• Postmarketing reports: Abnormal liver function tests, hepatitis (some cases have been fatal)^[Ref]

Hypersensitivity

Esomeprazole:

• Uncommon (0.1% to 1%): Allergic reaction
• Postmarketing reports: Anaphylactic reaction/shock^[Ref]

Metabolic

Esomeprazole:

• Uncommon (0.1% to 1%): Hyponatremia, increased alkaline phosphatase, vitamin B12 deficiency, weight increase, weight decrease, anorexia, appetite increased
• Postmarketing reports: Hypomagnesemia with or without hypocalcemia

Naproxen:

• Postmarketing reports: Hyperglycemia, hypoglycemia^[Ref]

Nervous system

Esomeprazole:

• Uncommon (0.1% to 1%): Hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, somnolence, tremor, taste loss
• Postmarketing reports: Hepatic encephalopathy, taste disturbance

Naproxen:

• Common (1% to 10%): Headache, dysgeusia, drowsiness, lightheadedness
• Uncommon (0.1% to 1%): Inability to concentrate
• Postmarketing reports: Cognitive dysfunction, convulsions^[Ref]

Ocular

Esomeprazole:

• Uncommon (0.1% to 1%): Visual field defect, conjunctivitis, vision abnormal
• Postmarketing reports: Blurred vision

Naproxen:

• Common (1% to 10%): Visual disturbances
• Postmarketing reports: Corneal opacity, papillitis, retrobulbar optic neuritis, papilledema^[Ref]

Psychiatric

Esomeprazole:

• Uncommon (0.1% to 1%): Sleep disorder, apathy, aggravated depression, confusion
• Postmarketing reports: Aggression, agitation, depression, hallucination

Naproxen:

• Postmarketing reports: Depression, dream abnormalities, insomnia^[Ref]

See also:

Further information

Esomeprazole/naproxen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer