TARO-LANSOPRAZOLE

Adverse Drug Reaction Overview Since 1991, lansoprazole has been approved in over 100 countries around the world, and about 250 million patients have been treated. Worldwide, over 10,000 patients have been treated with lansoprazole during Phase II-III short-term and long-term clinical trials involving various dosages and duration of treatment.

In general, lansoprazole treatment has been well tolerated. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Lansoprazole delayed-release capsules Short-Term Studies The following adverse events were reported to have a possible or probable relationship to drug as described by the treating physician in 1% or more of lansoprazole delayed-release capsules- treated patients who participated in placebo- and positive-controlled trials (Table 2 and Table 3, respectively).

Numbers in parentheses indicate the percentage of the adverse events reported. Table 2. 8) * Takeda Pharmaceuticals America, Inc. † Events reported by at least 1% of patients on either treatment are included. ‡ Doses 15 mg, 30 mg and 60 mg once daily for 4 to 8 weeks.

3%) lansoprazole-treated patients. 0%). 0%). 0%). Table 3. 3) * Events reported by at least 1% of patients on either treatment are included. † Doses 15 mg, 30 mg and 60 mg once daily for 4 to 8 weeks. NSAID-Associated Gastric Ulcer Studies The following tables summarize the most frequently reported treatment-emergent adverse events in the two (2) Healing studies and the Reduction of Risk study (Table 4 and Table 5, respectively).

Table 4. Most Frequently Reported* Treatment-Emergent Adverse Events by Treatment Group and Dose in the Principal Healing of NSAID-Associated Gastric Ulcer Studies† Body System/ COSTART Term Ranitidine 150 mg twice daily (N=235) (%) (n) Lansoprazole 15 mg once daily (N=235) (%) (n) Lansoprazole 30 mg once daily (N=231) (%) (n) Total Patients Any Event 47% (110) 43% (102) 52% (120) Body as a Whole Abdominal Pain 7% (17) 3% (7) 5% (11) Digestive System Diarrhea 8% (19) 11% (25) 9% (21) Respiratory System Pharyngitis 7% (16) 6% (13) 7% (17) * Reported by ≥ 5% of patients in any treatment group † Treatment Duration: 8 weeks Taro-Lansoprazole Page 14 of 83 Table 5.