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 pat