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Esomeprazole / naproxen Side Effects

In Summary

Commonly reported side effects of esomeprazole/naproxen include: increased liver enzymes. Other side effects include: constipation. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to esomeprazole / naproxen: oral tablet delayed release

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

Less Common

  • 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
  • stomach discomfort
  • 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

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

Less Common

  • Body aches or pain
  • change in taste
  • chills
  • cough
  • cough producing mucus
  • difficulty having a bowel movement
  • 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

General

Naproxen:

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

Gastrointestinal

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]

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]

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

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]

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]

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]

References

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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