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Vimovo Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vimovo (naproxen and esomeprazole magnesium) is a combination of a non-steroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor (PPI) used to treat signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. Common side effects of Vimovo include upset stomach, stomach pain, heartburn, nausea, gas, diarrhea, constipation, 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
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, 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.
Rarely, proton pump inhibitors (such as esomeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).
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, kidney problems (such as change in the amount of urine).
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
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforations [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
- Active Bleeding [see WARNINGS AND PRECAUTIONS]
- Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
- Cyanocobalamin (vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Bone Fracture [see WARNINGS AND PRECAUTIONS]
- Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Clinical Trials Experience With VIMOVO
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.
The safety of VIMOVO was evaluated in clinical studies involving 2317 patients (aged 27 to 90 years) and ranging from 3 to 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 and higher in the VIMOVO group than control 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* in Study 1 and Study 2 (endoscopic
|Preferred term||VIMOVO 500mg/20 mg twice daily
|EC-Naproxen 500 mg twice daily
|Upper respiratory tract infection||5||4|
|Urinary tract infection||2||1|
|*reported in > 2% of patients and higher in the VIMOVO group than control|
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 entericcoated naproxen.
The table below lists all adverse reactions, regardless of causality, occurring in > 2% of patients and higher in the VIMOVO group than placebo from 2 clinical studies conducted in patients with osteoarthritis of the knee (Study 3 and Study 4).
Table 2: Adverse Reactions*
in Study 3 and Study 4
|Preferred term||VIMOVO 500 mg/20 mg twice daily
|Abdominal Pain Upper||4||3|
|*reported in > 2% of patients and higher in the VIMOVO group than placebo|
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.
Clinical Trials Experience With Naproxen And Other NSAIDs
In patients taking naproxen in clinical trials, the most frequent reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal: heartburn, nausea, dyspepsia, stomatitis
Special Senses: tinnitus, visual disturbances, hearing disturbances
General: dyspnea, thirst
In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.
Gastrointestinal: gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes
The following are additional adverse experiences reported in < 1% of patients taking naproxen during clinical trials.
Nervous System: inability to concentrate
Dermatologic: skin rashes
In patients taking NSAIDs, the following adverse experiences have also been reported in < 1% of patients.
Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death
Hepatobiliary: hepatitis, liver failure
Metabolic and Nutritional: weight changes
Dermatologic: exfoliative dermatitis
Special Senses: blurred vision, conjunctivitis
Clinical Trials Experience With Esomeprazole Magnesium
Additional adverse reactions that were reported as possibly or probably related to NEXIUM with an incidence of < 1% are listed below by body system:
Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, malaise, pain, rigors
Cardiovascular: flushing, hypertension, tachycardia
Gastrointestinal: 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
Hearing: earache, tinnitus
Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect
Reproductive: dysmenorrhea, menstrual disorder, vaginitis
Special Senses: otitis media, parosmia, taste loss
Visual: conjunctivitis, vision abnormal
The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to esomeprazole, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.
Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration.
The following adverse reactions have been identified during post-approval use of VIMOVO. 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.
Body as a Whole: gait disturbance
Injury, Poisoning and Procedural Complications: contusion, fall
Musculoskeletal and Connective Tissue: joint swelling, muscle spasms
Urogenital: renal tubular necrosis
Body as a Whole: angioneurotic edema, menstrual disorders
Gastrointestinal: 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)
Hepatobiliary: hepatitis (some cases have been fatal)
Nervous System: depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions
Respiratory: eosinophilic pneumonitis
Dermatologic: alopecia, urticaria, 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
Blood and Lymphatic: agranulocytosis
Eye: blurred vision
Gastrointestinal: pancreatitis, microscopic colitis
Hepatobiliary: hepatic failure, hepatitis with or without jaundice
Immune System: anaphylactic reaction/shock
Infections and Infestations: GI candidiasis, Clostridium difficile associated diarrhea
Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture
Nervous System: hepatic encephalopathy
Psychiatric: aggression, agitation, hallucination
Renal and Urinary: interstitial nephritis
Reproductive System and Breast: gynecomastia
Respiratory, Thoracic, and Mediastinal: bronchospasm
Skin and Subcutaneous Tissue: alopecia, erythema multiforme, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
Read the entire FDA prescribing information for Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets)
Additional Vimovo Information
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