Vimovo

Vimovo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vimovo (naproxen and esomeprazole magnesium) is used to treat signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This medication contains naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole, a proton pump inhibitor (PPI). Common side effects include upset stomach, heartburn, diarrhea, drowsiness, or dizziness.

The dosage of Vimovo is one tablet twice daily, 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole. Vimovo may interact with amphetamines, oral bisphosphonates, blood thinners, anti-platelet drugs, SSRI/SNRI antidepressants, clopidogrel, corticosteroids, HIV drugs, lithium, probenecid, digoxin, azole antifungals, iron supplements, other products containing naproxen, other proton pump inhibitors. Check medicine labels as many contain pain relievers/fever reducers similar to Vimovo and may increase the risk of side effects if taken together. Tell your doctor all medications and supplements you are taking. Vimovo should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to the potential for harm to a fetus and interference with normal labor/delivery. Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breast-feeding.

Our Vimovo (naproxen and esomeprazole magnesium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vimovo in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vimovo Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Upset stomach, heartburn, diarrhea, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, lightheadedness/fainting, signs of a lung infection (such as fever, cough, trouble breathing), difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, change in amount of urine, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).

This drug may rarely cause serious (possibly fatal) liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, dark urine, yellowing eyes/skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, unexplained fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vimovo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reactions reported below are specific to the clinical trials with VIMOVO. See also the full prescribing information for naproxen and esomeprazole magnesium products.

The safety of VIMOVO was evaluated in clinical studies involving 2317 patients (aged 27 to 90 years) and ranging from 3-12 months. Patients received either 500 mg/20 mg of VIMOVO twice daily (n=1157), 500 mg of enteric-coated naproxen twice daily (n=426), or placebo (n=246). The average number of VIMOVO doses taken over 12 months was 696+44.

The table below lists all adverse reactions, regardless of causality, occurring in > 2% of patients receiving VIMOVO from two clinical studies (Study 1 and Study 2). Both of these studies were randomized, multi-center, double-blind, parallel studies. The majority of patients were female (67%), white (86%). The majority of patients were 50-69 years of age (83%). Approximately one quarter were on low-dose aspirin.

Table 1: Adverse Reactions occurring in patients > 2% Study 1 and Study 2 (endoscopic studies)

Preferred term (sorted by SOC) VIMOVO 500 mg/20 mg twice daily
(n=428) %
EC-Naproxen 500 mg twice daily
(n=426) %
Gastrointestinal Disorders
Gastritis Erosive 19 38
Dyspepsia 18 27
Gastritis 17 14
Diarrhea 6 5
Gastric Ulcer 6 24
Abdominal Pain Upper 6 9
Nausea 5 5
Hiatus Hernia 4 6
Abdominal Distension 4 4
Flatulence 4 3
Esophagitis 4 8
Constipation 3 3
Abdominal pain 2 2
Erosive Duodenitis 2 12
Abdominal pain lower 2 3
Duodenitis 1 7
Gastritis hemorrhagic 1 2
Gastroesophageal reflux disease < 1 4
Duodenal ulcer < 1 5
Erosive esophagitis < 1 6
Infections and infestations
Upper respiratory tract infection 5 4
Bronchitis 2 2
Urinary tract infection 2 1
Sinusitis 2 2
Nasopharyngitis < 1 2
Musculoskeletal and connective tissue disorders
Arthralgia 1 2
Nervous system disorders
Headache 3 1
Dysgeusia 2 1
Respiratory, thoracic and mediastinal disorders
Cough 2 3

In Study 1 and Study 2, patients taking VIMOVO had fewer premature discontinuations due to adverse reactions compared to patients taking enteric-coated naproxen alone (7.9% vs. 12.5% respectively). The most common reasons for discontinuations due to adverse events in the VIMOVO treatment group were upper abdominal pain (1.2%, n=5), duodenal ulcer (0.7%, n=3) and erosive gastritis (0.7%, n=3). Among patients receiving enteric-coated naproxen, the most common reasons for discontinuations due to adverse events were duodenal ulcer 5.4% (n=23), dyspepsia 2.8% (n=12) and upper abdominal pain 1.2% (n=5). The proportion of patients discontinuing treatment due to any upper gastrointestinal adverse events (including duodenal ulcers) in patients treated with VIMOVO was 4% compared to 12% for patients taking enteric-coated naproxen.

The table below lists all adverse reactions, regardless of causality, occurring in > 2% of patients from 2 clinical studies conducted in patients with osteoarthritis of the knee (Study 3 and Study 4).

Table 2: Adverse Reactions occurring in patients > 2% (Study 3 and Study 4)

Preferred term (sorted by SOC) VIMOVO 500 mg/20 mg twice daily
(n=490) %
Placebo
(n=246) %
Gastrointestinal Disorders
  Dyspepsia 8 12
  Diarrhea 6 4
  Abdominal Pain Upper 4 3
  Constipation 4 1
  Nausea 4 4
Nervous System Disorders
  Dizziness 3 2
  Headache 3 5
General disorders and administration site conditions
  Peripheral edema 3 1
Respiratory, thoracic and mediastinal disorders
  Cough 1 3
Infections and infestations
  Sinusitis 1 2

The percentage of subjects who withdrew from the VIMOVO treatment group in these studies due to treatment-emergent adverse events was 7%. There were no preferred terms in which more than 1% of subjects withdrew from any treatment group.

The long-term safety of VIMOVO was evaluated in an open-label clinical trial of 239 patients, of which 135 patients received 500 mg/20 mg of VIMOVO for 12 months. There were no differences in frequency or types of adverse reactions seen in the long-term safety study compared to shorter-term treatment in the randomized controlled studies.

Postmarketing Experience

Naproxen

The following adverse reactions have been identified during post-approval use of naproxen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:

Body as a Whole: anaphylactic reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: 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, peptic ulceration

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

Hemic and Lymphatic: eosinophilia, leukopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (female): infertility

Esomeprazole

The following adverse reactions have been identified during post-approval use of esomeprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:

Blood and Lymphatic: agranulocytosis, pancytopenia

Eye: blurred vision

Gastrointestinal: pancreatitis; stomatitis; microscopic colitis

Hepatobiliary: hepatic failure, hepatitis with or without jaundice

Immune System: anaphylactic reaction/shock

Infections and Infestations: GI candidiasis, Clostridium difficile associated diarrhea

Metabolism and Nutritional Disorders: hypomagnesemia

Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture

Nervous System: hepatic encephalopathy, taste disturbance

Psychiatric: aggression, agitation, depression, hallucination

Renal and Urinary: interstitial nephritis

Reproductive System and Breast: gynecomastia

Respiratory, Thoracic, and Mediastinal: bronchospasm

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Read the entire FDA prescribing information for Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets) »

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Vimovo - User Reviews

Vimovo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Vimovo sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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