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Esomeprazole / naproxen Side Effects

Not all side effects for esomeprazole / naproxen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to esomeprazole / naproxen: oral tablet delayed release

In addition to its needed effects, some unwanted effects may be caused by esomeprazole / naproxen. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking esomeprazole / naproxen:

More common
  • Burning feeling in the chest or stomach
  • indigestion
  • loss of appetite
  • nausea
  • stomach bloating, cramping, or pain
  • tenderness in the stomach area
  • upper abdominal or stomach pain
  • upset stomach
  • vomiting
  • weight loss
Less common
  • Abdominal or stomach discomfort
  • 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 breathing
  • 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
  • swelling of the abdominal or stomach area
  • tingling of the hands or feet
  • unusual weight gain or loss
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Drowsiness
  • mood or mental changes
  • muscle spasms (tetany) or twitching
  • seizures
  • trembling
  • unusual tiredness or weakness
  • vomiting

Some of the side effects that can occur with esomeprazole / naproxen may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • diarrhea
Less common
  • Body aches or pain
  • change in taste
  • chills
  • cough
  • cough producing mucus
  • difficulty having a bowel movement (stool)
  • ear congestion
  • excess air or gas in the stomach or intestines
  • fever
  • headache
  • loss of taste
  • loss of voice
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • sneezing
  • sore throat
  • stuffy or runny nose

For Healthcare Professionals

Applies to esomeprazole / naproxen: oral delayed release tablet


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

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

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

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]


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

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


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

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

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


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

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

Postmarketing reports: Myalgia, muscle weakness[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]

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

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

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


Postmarketing reports: Gait disturbances

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

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


Postmarketing reports: Renal tubular necrosis

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

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


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)

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]


Uncommon (0.1% to 1%): Goiter[Ref]


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

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


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

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


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


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

Postmarketing reports: Hyperglycemia, hypoglycemia[Ref]

Nervous system

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

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


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

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


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

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


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. VIMOVO (esomeprazole-naproxen)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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. 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.