Esomeprazole / naproxen Side Effects
Some side effects of esomeprazole / naproxen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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
- Burning feeling in the chest or stomach
- loss of appetite
- stomach bloating, cramping, or pain
- tenderness in the stomach area
- upper abdominal or stomach pain
- upset stomach
- weight loss
- 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
- 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
- mood or mental changes
- muscle spasms (tetany) or twitching
- 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
- Acid or sour stomach
- Body aches or pain
- change in taste
- cough producing mucus
- difficulty having a bowel movement (stool)
- difficulty with breathing
- ear congestion
- excess air or gas in the stomach or intestines
- loss of taste
- loss of voice
- pain or tenderness around the eyes and cheekbones
- passing gas
- shortness of breath or troubled breathing
- sore throat
- stuffy or runny nose
- tightness of the chest or wheezing
For Healthcare Professionals
Applies to esomeprazole / naproxen: oral delayed release tablet
Gastrointestinal side effects have included erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea, hiatus hernia, abdominal distension, flatulence, esophagitis, constipation, abdominal pain, erosive duodenitis, lower abdominal pain, duodenitis, hemorrhagic gastritis, gastroesophageal reflux disease, duodenal ulcer, and erosive esophagitis. Postmarketing reports have included gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, microscopic colitis, and peptic ulceration.
Cardiovascular side effects have included congestive heart failure, vasculitis, hypertension, pulmonary edema, and peripheral edema.
Respiratory side effects have included upper respiratory tract infection, bronchitis, bronchospasm, sinusitis, cough and nasopharyngitis. Postmarketing reports have included eosinophilic pneumonitis and asthma.
Musculoskeletal side effects have included muscle spasm (tetany), arthralgia, aggravation of arthritis, arthropathy, cramps, fibromyalgia syndrome, hernia, hypertonia, polymyalgia rheumatica, and back pain. Myalgia and bone fracture have also been reported.
Nervous system side effects have included headache, dizziness, and dysgeusia. Postmarketing reports have included inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, hepatic encephalopathy, taste disturbance, and seizures.
Hepatic side effects have included jaundice, abnormal liver function tests, and hepatitis (some cases have been fatal).
Hematologic side effects have included eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, pancytopenia, hemolytic anemia, and aplastic anemia.
Dermatologic side effects have included alopecia, urticaria, skin rashes, hyperhidrosis, 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, and toxic epidermal necrolysis (some fatal).
Hypersensitivity side effects have included anaphylactoid reactions, shock, and angioneurotic edema.
Endocrine side effects have included hyperglycemia and hypoglycemia.
Ocular side effects have included blurred vision, corneal opacity, papillitis, retrobulbar optic neuritis, and papilledema.
Renal side effects have included glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, raised serum creatinine, and renal papillary necrosis.
Genitourinary side effects have included infertility, gynecomastia, and menstrual disorders.
General side effects have included pyrexia (chills and fever).
Psychiatric side effects have included aggression, agitation, depression, and hallucination.
FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year).
More about esomeprazole/naproxen
- Naproxen/esomeprazole delayed-release tablets
- Esomeprazole and naproxen
- Naproxen and esomeprazole (Advanced Reading)
- Other brands: Vimovo
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