Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ).
Most common adverse reactions in adolescents (≥2%) are headache, diarrhea, nausea, vomiting, and abdominal pain ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc.
at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.3 )] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions ( 5.4 )] Bone Fracture [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [ see Warnings and Precautions ( 5.7 ) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.9 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )] 6.1 Clinical Studies Experience Because clinical trials are conducted under 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.
Adults The data described below reflect exposure to rabeprazole sodium delayed-release tablets in 1,064 adult patients exposed for up to 8 weeks.
The studies were primarily placebo- and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers.
The population had a mean age of 53 years (range 18 to 89 years) and had a ratio of approximately 60% male: 40% female.
The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other.
Most patients received either 10 mg, 20 mg or 40 mg per day of rabeprazole sodium delayed-release tablets.
An analysis of adverse reactions appearing in ≥2% of patients treated with rabeprazole sodium delayed-release tablets (n=1,064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs.
5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.
Consider additional follow-up and diagnostic testing ( 5.1 ).
Use with Warfarin : Monitor for increases in INR and prothrombin time ( 5.2 , 7 ).
Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients ( 5.3 ).
Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk of ( 5.4 ).
Like all medications, Rabeprazole Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: