Vimovo Side Effects
Generic name: esomeprazole / naproxen
Note: This document contains side effect information about esomeprazole / naproxen. Some of the dosage forms listed on this page may not apply to the brand name Vimovo.
Some side effects of Vimovo 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 delayed release tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking esomeprazole / naproxen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such as:
pale skin, easy bruising, unusual bleeding, or any bleeding that will not stop;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
pain, swelling, warmth, or redness in one or both legs;
low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);
urinating less than usual or not at all;
swelling, rapid weight gain, feeling short of breath (even with mild exertion);
diarrhea that is watery or bloody;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects of esomeprazole / naproxen may include:
constipation, mild diarrhea; or
mild stomach pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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 Vimovo resources
- Vimovo Prescribing Information (FDA)
- Vimovo Advanced Consumer (Micromedex) - Includes Dosage Information
- Vimovo delayed-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Vimovo Consumer Overview
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