Esomeprazole / Naproxen Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 8, 2024.

Applies to esomeprazole / naproxen: oral tablet delayed release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet, delayed release)

There is an increased risk of serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke with NSAID use, especially with longer durations, a history of CV disease, or risk factors for CV disease.

NSAIDs increase the risk of serious and sometimes fatal gastrointestinal (GI) adverse events, which can include bleeding, ulceration, and perforation of the stomach or intestines.

The elderly are at increased risk.

These GI events can occur at any time without warning.

This drug is contraindicated for the treatment of perioperative pain related to CABG surgery.

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:

More common side effects

• blistering, peeling, or reddening of the skin
• burning feeling in the chest or stomach
• indigestion
• loss of appetite
• nausea
• stomach bloating, cramping, pain, tenderness, or upset
• upper abdominal or stomach pain
• vomiting
• weight loss

Less common side effects

• black, tarry stools
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• bloody stools
• chest pain
• difficult, burning, or painful urination
• difficulty with moving
• difficulty with swallowing
• frequent urge to urinate
• full or bloated feeling
• heartburn
• lower back or side pain
• muscle pain or stiffness
• pain in the joints
• pain or burning in the throat
• pressure in the stomach
• rapid weight gain
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach discomfort or swelling
• tingling of the hands or feet
• trouble breathing
• unusual weight gain or loss
• vomiting of blood or material that looks like coffee grounds

Incidence not known

• chills
• confusion
• cough
• drowsiness
• dry mouth
• fever
• mood or mental changes
• muscle cramps, spasms (tetany), or twitching
• numbness and tingling around the mouth, fingertips, or feet
• seizures
• sore throat
• stomach cramps
• swollen glands
• trembling
• unusual bleeding or bruising
• unusual tiredness or weakness

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:

More common side effects

• belching
• diarrhea

Less common side effects

• body aches or pain
• change in taste
• cough producing mucus
• difficulty having a bowel movement
• ear congestion
• excess air or gas in the stomach or bowels
• fever
• increased sensitivity of the skin to sunlight
• loss of taste
• loss of voice
• loss or thinning of the hair
• pain or tenderness around the eyes and cheekbones
• passing gas
• severe sunburn
• sneezing
• stuffy or runny nose

Incidence not known

• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

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]

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