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 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)
  • difficulty with breathing
  • 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
  • shortness of breath or troubled breathing
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing

For Healthcare Professionals

Applies to esomeprazole / naproxen: oral delayed release tablet

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

Esomeprazole:
Postmarketing reports: Pancreatitis; stomatitis; microscopic colitis, GI candidiasis, Clostridium difficile associated diarrhea

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.

Cardiovascular

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

Naproxen:
Postmarketing reports: Congestive heart failure, vasculitis, hypertension, pulmonary edema

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.

Respiratory

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

Esomeprazole:
Postmarketing reports: Bronchospasm

Naproxen:
Postmarketing reports: Eosinophilic pneumonitis, asthma

Musculoskeletal

Esomeprazole-naproxen:
Common (1% to 10%): Arthralgia

Esomeprazole:
Postmarketing reports: Muscular weakness, myalgia, bone fracture

Nervous system

Esomeprazole-naproxen:
Common (1% to 10%): Headache, dysgeusia

Esomeprazole:
Postmarketing reports: Hepatic encephalopathy, taste disturbance

Naproxen:
Postmarketing reports: Inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Hepatic

Esomeprazole:
Postmarketing reports: Hepatic failure, hepatitis with or without jaundice

Naproxen:
Postmarketing reports: Jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

Hematologic

Esomeprazole:
Postmarketing reports: Agranulocytosis, pancytopenia

Naproxen:
Postmarketing reports: Eosinophilia, leukopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Dermatologic

Esomeprazole:
Postmarketing reports: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Naproxen:
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

Hypersensitivity

Esomeprazole:
Postmarketing reports: Anaphylactic reaction/shock

Endocrine

Esomeprazole:
Postmarketing reports: Gynecomastia

Naproxen:
Postmarketing reports: Infertility (female)

Ocular

Esomeprazole:
Postmarketing reports: Blurred vision

Naproxen:
Postmarketing reports: Corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Renal

Esomeprazole:
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

Genitourinary

Esomeprazole-naproxen:
Common (1% to 10%): Urinary tract infection

General

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

Psychiatric

Esomeprazole:
Postmarketing reports: Aggression, agitation, depression, hallucination

Metabolic

Esomeprazole:
Postmarketing reports: Hypomagnesemia

Naproxen:
Postmarketing reports: Hyperglycemia, hypoglycemia

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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