FDA label 04630301-16dc-4257-bd8e-e11a63441e81

WARNINGS Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer (see PRECAUTIONS ).

ADVERSE REACTIONS Daily Dosing Osteoporosis Risedronate has been studied in over 5700 patients enrolled in the Phase 3 glucocorticoid-induced osteoporosis clinical trials and in postmenopausal osteoporosis trials of up to 3 years duration. The overall adverse event profile of risedronate sodium tablets 5 mg in these studies was similar to that of placebo. Most adverse events were either mild or moderate and did not lead to discontinuation from the study. The incidence of serious adverse events in the placebo group was 24.9% and in the risedronate sodium tablets 5 mg group was 26.3%. The percentage of patients who withdrew from the study due to adverse events was 14.4% and 13.5% for the placebo and risedronate sodium tablets 5 mg groups, respectively. Table 5 lists adverse events from the Phase 3 osteoporosis trials reported in ≥ 2% of patients and in more risedronate-treated patients than placebo-treated patients. Adverse events are shown without attribution of causality. Table 5: Adverse Events Occurring at a Frequency ≥ 2% and in More Risedronate-Treated Patients than Placebo-Treated Patients; Combined Phase 3 Osteoporosis Trials Body System Placebo % (N = 1914) Risedronate Sodium Tablets 5 mg % (N = 1916) Body as a Whole Infection 29.7 29.9 Back Pain 23.6 26.1 Pain 13.1 13.6 Abdominal Pain 9.4 11.6 Neck Pain 4.5 5.3 Asthenia 4.3 5.1 Chest Pain 4.9 5.0 Neoplasm 3.0 3.3 Hernia 2.5 2.9 Cardiovascular Hypertension 9.0 10.0 Cardiovascular Disorder 1.7 2.5 Angina Pectoris 2.4 2.5 Digestive Nausea 10.7 10.9 Diarrhea 9.6 10.6 Flatulence 4.2 4.6 Gastritis 2.3 2.5 Gastrointestinal Disorder 2.1 2.3 Rectal Disorder 1.9 2.2 Tooth Disorder 2.0 2.1 Hemic and Lymphatic Ecchymosis 4.0 4.3 Anemia 1.9 2.4 Musculoskeletal Arthralgia 21.1 23.7 Joint Disorder 5.4 6.8 Myalgia 6.3 6.6 Bone Pain 4.3 4.6 Bone Disorder 3.2 4.0 Leg Cramps 2.6 3.5 Bursitis 2.9 3.0 Tendon Disorder 2.5 3.0 Nervous Depression 6.2 6.8 Dizziness 5.4 6.4 Insomnia 4.5 4.7 Anxiety 3.0 4.3 Neuralgia 3.5 3.8 Vertigo 3.2 3.3 Hypertonia 2.1 2.2 Paresthesia 1.8 2.1 Respiratory Pharyngitis 5.0 5.8 Rhinitis 5.0 5.7 Dyspnea 3.2 3.8 Pneumonia 2.6 3.1 Skin and Appendages Rash 7.2 7.7 Pruritus 2.2 3.0 Skin Carcinoma 1.8 2.0 Special Senses Cataract 5.4 5.9 Conjunctivitis 2.8 3.1 Otitis Media 2.4 2.5 Urogenital Urinary Tract Infection 9.7 10.9 Cystitis 3.5 4.1 Duodenitis and glossitis have been reported uncommonly (0.1% to 1%). There have been rare reports (< 0.1%) of abnormal liver function tests. Laboratory Test Findings Throughout the Phase 3 studies, transient decreases from baseline in serum calcium (< 1%) and serum phosphate (< 3%) and compensatory increases in serum PTH levels (< 30%) were observed within 6 months in patients in osteoporosis clinical trials treated with risedronate sodium tablets 5 mg once daily. There were no significant differences in serum calcium, phosphate, or PTH levels between risedronate sodium tablets 5 mg once daily and placebo at 3 years. Serum calcium levels below 8 mg/dL were observed in 18 patients, 9 (0.5%) in each treatment arm (risedronate sodium tablets 5 mg once daily and placebo). Serum phosphorus levels below 2 mg/dL were observed in 14 patients, 11 (0.6%) treated with risedronate sodium tablets 5 mg once daily and 3 (0.2%) treated with placebo. Endoscopic Findings Risedronate clinical studies enrolled over 5700 patients, many with preexisting gastrointestinal disease and concomitant use of NSAIDs or aspirin. Investigators were encouraged to perform endoscopies in any patients with moderate-to-severe gastrointestinal complaints, while maintaining the blind. These endoscopies were ultimately performed on equal numbers of patients between the treated and placebo groups [75 (14.5%) placebo; 75 (11.9%) risedronate]. Across treatment groups, the percentage of patients with normal esophageal, gastric, and duodenal mucosa on endoscopy was similar (20% placebo, 21% risedronate). The number of patients who withdrew from the studies due to the event prompting endoscopy was similar across treatment groups. Positive findings on endoscopy were also generally comparable across treatment groups. There was a higher number of reports of mild duodenitis in the risedronate group, however there were more duodenal ulcers in the placebo group. Clinically important findings (perforations, ulcers, or bleeding) among this symptomatic population were similar between groups (51% placebo; 39% risedronate). Once-A-Week Dosing In a 1 year, double-blind, multicenter study comparing risedronate sodium tablets 5 mg daily and risedronate sodium tablets 35 mg once a week in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar. Table 6 lists the adverse events in ≥ 2% of patients from this trial. Events are shown without attribution of causality. Table 6: Adverse Events Occurring in ≥ 2% of Patients of Either Treatment Group in the Daily vs. Weekly Osteoporosis Treatment Study in Postmenopausal Women Body System 5 mg Daily Risedronate Sodium Tablets % (N = 480) 35 mg Weekly Risedronate Sodium Tablets % (N = 485) Body as a Whole Infection 19.0 20.6 Accidental Injury 10.6 10.7 Pain 7.7 9.9 Back Pain 9.2 8.7 Flu Syndrome 7.1 8.5 Abdominal Pain 7.3 7.6 Headache 7.3 7.2 Overdose 6.9 6.8 Asthenia 3.5 5.4 Chest Pain 2.3 2.7 Allergic Reaction 1.9 2.5 Neoplasm 0.8 2.1 Neck Pain 2.7 1.2 Cardiovascular System Hypertension 5.8 4.9 Syncope 0.6 2.1 Vasodilatation 2.3 1.4 Digestive System Constipation 12.5 12.2 Dyspepsia 6.9 7.6 Nausea 8.5 6.2 Diarrhea 6.3 4.9 Gastroenteritis 3.8 3.5 Flatulence 3.3 3.1 Colitis 0.8 2.5 Gastrointestinal Disorder 1.9 2.5 Vomiting 1.9 2.5 Dry Mouth 2.5 1.4 Metabolic and Nutritional Disorders Peripheral Edema 4.2 1.6 Musculoskeletal System Arthralgia 11.5 14.2 Traumatic Bone Fracture 5.0 6.4 Myalgia 4.6 6.2 Arthritis 4.8 4.1 Bursitis 1.3 2.5 Bone Pain 2.9 1.4 Nervous System Dizziness 5.8 4.9 Anxiety 0.6 2.7 Depression 2.3 2.3 Vertigo 2.1 1.6 Respiratory System Bronchitis 2.3 4.9 Sinusitis 4.6 4.5 Pharyngitis 4.6 2.9 Cough Increased 3.1 2.5 Pneumonia 0.8 2.5 Rhinitis 2.3 2.1 Skin and Appendages Rash 3.1 4.1 Pruritus 1.9 2.3 Special Senses Cataract 2.9 1.9 Urogenital System Urinary Tract Infection 2.9 5.2 Laboratory Test Findings In a 1 year study comparing daily versus weekly oral dosing regimens of risedronate sodium tablets in postmenopausal women, the mean percent changes from baseline at 12 months were similar between the risedronate sodium tablets 5 mg daily and risedronate sodium tablets 35 mg once a week groups, respectively, for serum calcium (0.4% and 0.7%), phosphate (- 3.8% and - 2.6%) and PTH (6.4% and 4.2%). Paget's Disease Risedronate has been studied in 392 patients with Paget's disease of bone. As in trials of risedronate for other indications, the adverse experiences reported in the Paget's disease trials have generally been mild or moderate, have not required discontinuation of treatment, and have not appeared to be related to patient age, gender, or race. In a double-blind, active-controlled study, the adverse event profile was similar for risedronate and etidronate disodium: 6.6% (4/61) of patients treated with risedronate sodium tablets 30 mg daily for 2 months discontinued treatment due to adverse events, compared to 8.2% (5/61) of patients treated with etidronate disodium tablets 400 mg daily for 6 months. Table 7: Adverse Events Reported in ≥ 2% of Risedronate-Treated Patients Considered to be possibly or probably causally related in at least one patient. in Phase 3 Paget’s Disease Trials Body System 30 mg/day times 2 months Risedronate Sodium Tablets % (n = 61) 400 mg/day times 6 months Etidronate Disodium Tablets % (n = 61) Body as a Whole Flu Syndrome 9.8 1.6 Chest Pain 6.6 3.3 Asthenia 4.9 0.0 Neoplasm 3.3 1.6 Gastrointestinal Diarrhea 19.7 14.8 Abdominal Pain 11.5 8.2 Nausea 9.8 9.8 Constipation 6.6 8.2 Belching 3.3 1.6 Colitis 3.3 3.3 Metabolic and Nutritional Disorders Peripheral Edema 8.2 6.6 Musculoskeletal Arthralgia 32.8 29.5 Bone Pain 4.9 4.9 Leg Cramps 3.3 3.3 Myasthenia 3.3 0.0 Nervous Headache 18.0 16.4 Dizziness 6.6 4.9 Respiratory Bronchitis 3.3 4.9 Sinusitis 4.9 1.6 Skin and Appendages Rash 11.5 8.2 Special Senses Amblyopia 3.3 3.3 Tinnitus 3.3 3.3 Dry Eye 3.3 0.0 Ocular Adverse Events Three patients who received risedronate sodium tablets 30 mg daily experienced acute iritis in 1 supportive study. All 3 patients recovered from their events; however, in 1 of these patients, the event recurred during risedronate treatment and again during treatment with pamidronate. All patients were effectively treated with topical steroids. Postmarketing Experience Very rare hypersensitivity and skin reactions have been reported, including angioedema, generalized rash and bullous skin reactions, some severe. Musculoskeletal: bone, joint, or muscle pain, rarely described as severe or incapacitating (see PRECAUTIONS , Musculoskeletal Pain ). Very rare reactions of eye inflammation including iritis and uveitis have been reported. Osteonecrosis of the jaw has been reported very rarely (see PRECAUTIONS , Jaw Osteonecrosis ).

<table border="1" width="439" ID="inv-c69cb06f-d99d-42da-aee4-cc5a1cd00738"> <caption ID="inv-ed93a597-3817-472b-8e95-4bb7926cc22b">Table 5: Adverse Events Occurring at a Frequency &#x2265; 2% and in More Risedronate-Treated Patients than Placebo-Treated Patients; Combined Phase 3 Osteoporosis Trials</caption> <col width="33.7%"/> <col width="33.7%"/> <col width="32.6%"/> <tbody> <tr ID="id_d3cd08a8-c3c4-4a0e-b665-1e684c8c4ea1"> <td align="left" valign="top" styleCode="Botrule Toprule Rrule Lrule">Body System </td> <td align="center" valign="top" styleCode="Botrule Rrule">Placebo % (N = 1914) </td> <td align="center" valign="top" styleCode="Botrule Rrule">Risedronate Sodium Tablets 5 mg % (N = 1916) </td> </tr> <tr ID="id_ae6ae06b-0d3b-4112-9ce5-3dafe047de56"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Body as a Whole </td> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_31bdc336-8fdd-447a-8bc0-14d086c40f7d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Infection </td> <td align="center" valign="top" styleCode="Botrule Rrule">29.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">29.9</td> </tr> <tr ID="id_31f54e63-bcef-4c40-b2d0-530967b91fa7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Back Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">23.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">26.1 </td> </tr> <tr ID="id_c4a3fca2-6c2e-4164-af88-01836cffbc79"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">13.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">13.6 </td> </tr> <tr ID="id_20e7e4bf-1f9b-4fa8-a258-dc6e8594abdc"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Abdominal Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.4 </td> <td align="center" valign="top" styleCode="Botrule Rrule">11.6 </td> </tr> <tr ID="id_26f08631-68b6-42d1-9f17-dbd8b4e09583"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neck Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.3 </td> </tr> <tr ID="id_d7aae18e-da4e-46f8-8625-7582b241c55e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Asthenia </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.1 </td> </tr> <tr ID="id_9cac200a-485d-4d57-85ce-5753bde3fa5c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Chest Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.0 </td> </tr> <tr ID="id_ed78b51d-2cea-4917-b6a8-077ba1d10d01"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neoplasm </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_cac8d1d0-2850-4ee9-80a5-fef8c5551de8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Hernia </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td> </tr> <tr ID="id_38a1733b-151b-486e-b987-05b5263bd1b5"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Cardiovascular </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_0070db2e-c081-40a0-bea4-62759da4e5fe"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Hypertension </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.0 </td> </tr> <tr ID="id_60af7f33-7244-4c50-b7ad-ab1aec4fbd18"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Cardiovascular Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_2a4f62db-e07f-477f-966b-4a793b5aa8a0"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Angina Pectoris </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.4 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_b98ffdb4-03f2-42f3-8d07-77a6b6b2a4d4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Digestive </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_e32dbda1-29fd-48df-8c3b-017b278f1a3d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nausea </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.9 </td> </tr> <tr ID="id_48411b26-0f54-4242-bf2b-a0bd7dabcfa1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Diarrhea </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.6 </td> </tr> <tr ID="id_2ab1cbb9-4224-444a-9c67-209e1302352e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Flatulence </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.6 </td> </tr> <tr ID="id_88a985e5-f67b-4885-b419-8bb9d70ecbfe"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Gastritis </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_6b9015ef-c8a9-4567-bec4-16eac9282990"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Gastrointestinal Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> </tr> <tr ID="id_38871f23-e94e-478e-8573-29193876a0e3"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rectal Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.2 </td> </tr> <tr ID="id_9fb0bed9-5b2d-4150-9a8e-9e32d58fcc7c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Tooth Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> </tr> <tr ID="id_ae59c875-fe97-4d4b-b4b0-c154b757791d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Hemic and Lymphatic </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_b73121b8-a967-41f7-ba24-bdf4c1b0eb62"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Ecchymosis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.3 </td> </tr> <tr ID="id_499b26bc-f649-4a71-a5e9-f4837a85c3a8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Anemia</td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.4 </td> </tr> <tr ID="id_ec440309-39cb-46bb-8e0d-73500a7eb117"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Musculoskeletal </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_f21b7ae3-821a-483a-9e77-d2c0f8b47b67"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Arthralgia </td> <td align="center" valign="top" styleCode="Botrule Rrule">21.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">23.7 </td> </tr> <tr ID="id_db7010c5-bc40-4808-a501-856909564558"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Joint Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.4 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.8 </td> </tr> <tr ID="id_69e40024-9b6b-4993-bb2f-7ab5874cd3e7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Myalgia </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.6 </td> </tr> <tr ID="id_3df056d6-963c-4695-a5cd-124a5cc57cf9"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bone Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.6 </td> </tr> <tr ID="id_956ca782-a1e4-4049-866a-8f16492bf740"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bone Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.0 </td> </tr> <tr ID="id_339fa625-809d-45b6-a405-0bfad07d0c3b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Leg Cramps </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td> </tr> <tr ID="id_87ec6464-c37f-4ad4-82a2-021a3bdd18b6"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bursitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.0 </td> </tr> <tr ID="id_49dc8b41-8d69-466b-9fd9-793255c98442"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Tendon Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.0 </td> </tr> <tr ID="id_7fc76e5e-42e8-45fd-a3e1-5faa55559805"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Nervous </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_9e9e9364-0d31-4979-94bf-6c01006de2e6"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Depression </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.8 </td> </tr> <tr ID="id_ef9529f8-d9b5-4868-ad47-968ef5f13c66"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dizziness</td> <td align="center" valign="top" styleCode="Botrule Rrule">5.4</td> <td align="center" valign="top" styleCode="Botrule Rrule">6.4</td> </tr> <tr ID="id_0d950bd5-7db6-4d7d-b367-f72a2ef2e7b9"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Insomnia</td> <td align="center" valign="top" styleCode="Botrule Rrule">4.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.7 </td> </tr> <tr ID="id_c14d1595-60f5-4db8-9893-0c1302c03ede"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Anxiety</td> <td align="center" valign="top" styleCode="Botrule Rrule">3.0</td> <td align="center" valign="top" styleCode="Botrule Rrule">4.3 </td> </tr> <tr ID="id_31dc5870-2f23-46b3-b291-c32adb00047c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neuralgia</td> <td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.8 </td> </tr> <tr ID="id_ddee8702-1101-480e-b756-3fe584eb9a0d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Vertigo</td> <td align="center" valign="top" styleCode="Botrule Rrule">3.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_e09fd334-3900-4709-953f-978ea06d57fd"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Hypertonia</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.2 </td> </tr> <tr ID="id_11e6ee67-fd3f-495f-962f-abd7f5997421"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Paresthesia</td> <td align="center" valign="top" styleCode="Botrule Rrule">1.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> </tr> <tr ID="id_905e2c78-b9f2-4395-96f6-dd2b1fc46c6c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Respiratory</td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_6f8f09d9-9e15-4bbc-b173-77d50d9d7074"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pharyngitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">5.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.8 </td> </tr> <tr ID="id_695f1dbe-221e-4449-acff-3e29132ccea2"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rhinitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">5.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.7 </td> </tr> <tr ID="id_5d52052e-afa5-4bdd-bf36-6fd8ab6c1e2d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dyspnea</td> <td align="center" valign="top" styleCode="Botrule Rrule">3.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.8 </td> </tr> <tr ID="id_b80f9a01-8a1e-4de5-a4c2-5509ab5e2ff9"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pneumonia</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.1 </td> </tr> <tr ID="id_76f3cfae-896e-4281-884c-e3727646d84c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Skin and Appendages</td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_eb44e14d-4bee-41c1-89f2-fd89cebe83f5"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rash</td> <td align="center" valign="top" styleCode="Botrule Rrule">7.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.7 </td> </tr> <tr ID="id_ebe6c35a-62df-4134-aeb3-afb4bf10cc3f"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pruritus</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.0 </td> </tr> <tr ID="id_c5d34270-3768-4b69-b491-c314eacf349b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Skin Carcinoma</td> <td align="center" valign="top" styleCode="Botrule Rrule">1.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.0 </td> </tr> <tr ID="id_566e615b-98c0-4593-9c2d-7f20e6e9dc46"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Special Senses</td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_e9f63c59-63ba-4364-89dd-55c828e714f7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Cataract</td> <td align="center" valign="top" styleCode="Botrule Rrule">5.4 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.9 </td> </tr> <tr ID="id_9d5d2609-8a45-4d85-a605-7518ed526e3b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Conjunctivitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.1 </td> </tr> <tr ID="id_8e778c3e-c139-4cf3-adca-ca616dee5398"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Otitis Media</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.4 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_c1eabaf4-be99-4c9b-ac0c-a2aae737b47b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Urogenital</td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_c85f8ed2-d779-4026-912b-dae9e8954205"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Urinary Tract Infection</td> <td align="center" valign="top" styleCode="Botrule Rrule">9.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.9 </td> </tr> <tr ID="id_2cb21657-5d67-4d4c-8f55-c8fd8027b7dd"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Cystitis</td> <td align="center" valign="top" styleCode="Rrule">3.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.1 </td> </tr> </tbody> </table>

<table border="1" width="439" ID="inv-811fb5b5-c998-42a5-8c56-b848bedfcfd4"> <caption ID="inv-9b7fa106-24e0-42c3-ac61-17227deefa5a">Table 6: Adverse Events Occurring in &#x2265; 2% of Patients of Either Treatment Group in the Daily vs. Weekly Osteoporosis Treatment Study in Postmenopausal Women</caption> <col width="33.7%"/> <col width="33.7%"/> <col width="32.6%"/> <tbody> <tr ID="id_1a354ce4-0eb3-4e55-96e6-5d2406aacb84"> <td align="left" valign="bottom" styleCode="Botrule Toprule Rrule Lrule">Body System </td> <td align="center" valign="top" styleCode="Botrule Rrule">5 mg Daily Risedronate Sodium Tablets % (N = 480) </td> <td align="center" valign="top" styleCode="Botrule Rrule">35 mg Weekly Risedronate Sodium Tablets % (N = 485) </td> </tr> <tr ID="id_1507bb63-6877-4951-a98d-2b4a342b713b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Body as a Whole </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_ef733bd7-86c0-47b4-8e95-7fb5ffd0cc01"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Infection </td> <td align="center" valign="top" styleCode="Botrule Rrule">19.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">20.6 </td> </tr> <tr ID="id_8c9ba4e8-d127-4465-965a-ca78ba023409"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Accidental Injury </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">10.7 </td> </tr> <tr ID="id_3e23ed73-a16b-42bd-9e82-81f83aa5682f"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.9 </td> </tr> <tr ID="id_039975e4-1bd2-440e-a3f6-6dee7414de35"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Back Pain</td> <td align="center" valign="top" styleCode="Botrule Rrule">9.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.7 </td> </tr> <tr ID="id_590dc32b-0352-4f0b-b81f-7d2e73846727"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Flu Syndrome </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.5 </td> </tr> <tr ID="id_a47ed5a0-bf15-43a1-8e74-4d63b1fafafa"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Abdominal Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.6 </td> </tr> <tr ID="id_b3402872-966d-4c8f-9367-0397ab6ff526"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Headache </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.2 </td> </tr> <tr ID="id_f716ddf4-f796-40e4-9c13-46fac146ddc4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Overdose </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.8 </td> </tr> <tr ID="id_18b6774e-4deb-4605-87c5-f547c802a1af"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Asthenia </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.4 </td> </tr> <tr ID="id_73be8c84-b521-421f-9340-7b6c60facac7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Chest Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.7 </td> </tr> <tr ID="id_1943e519-05b9-484c-b8d2-6d8bd97c98d0"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Allergic Reaction </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_de8670a1-5232-476a-8ef9-d6c9dbf57ad0"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neoplasm </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> </tr> <tr ID="id_bfc61a61-4b84-400d-92d3-b02f3e192b13"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neck Pain</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.2 </td> </tr> <tr ID="id_2aaac355-75cd-4885-8264-c427a97acd65"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Cardiovascular System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_d0e384ab-4b05-4f8a-9a30-402a2cb608bf"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Hypertension </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_d7581d35-c41b-421a-ba92-82552c23779c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Syncope </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> </tr> <tr ID="id_e3581580-efaf-4f74-9de6-306c9a86fd56"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Vasodilatation </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.4 </td> </tr> <tr ID="id_51edf5ee-d19e-4b63-9e15-50cb9c14aff7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Digestive System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_ee6206fe-f961-41a1-afb8-7af56deb05d5"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Constipation </td> <td align="center" valign="top" styleCode="Botrule Rrule">12.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">12.2 </td> </tr> <tr ID="id_8dd8ce3c-fab1-4103-b096-bf062721affb"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dyspepsia </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">7.6 </td> </tr> <tr ID="id_7afcd82c-71fe-465f-91c6-7ed99e5fe38d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nausea </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.2 </td> </tr> <tr ID="id_1bfddc6c-71f7-40f7-a55b-d257ae3c13ae"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Diarrhea</td> <td align="center" valign="top" styleCode="Botrule Rrule">6.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_4a20e9ab-5adb-406b-9421-bdc4dc492212"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Gastroenteritis</td> <td align="center" valign="top" styleCode="Botrule Rrule">3.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td> </tr> <tr ID="id_33d96adc-a79f-48fc-8de7-4488176f3c02"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Flatulence </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.1 </td> </tr> <tr ID="id_cd3603dd-756e-4094-be3d-a18f4481427e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Colitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_a55b85b5-475a-46ff-bfe9-ca0c50196ab8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Gastrointestinal Disorder </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_630508cc-486a-49cc-a18d-a924f3dad08d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Vomiting </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_546338ec-0b30-4793-8a1f-96e639485c53"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dry Mouth </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.4 </td> </tr> <tr ID="id_cafd22ce-8ea0-49ed-a08d-2dc65c0c2113"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Metabolic and Nutritional Disorders </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_646bf7ec-cab7-41a1-b370-97f8b6739f5e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Peripheral Edema </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_246f0b69-e5f3-419c-9238-105b88f2a914"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Musculoskeletal System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_10513964-152e-47a3-8fa1-4e0790b1641b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Arthralgia </td> <td align="center" valign="top" styleCode="Botrule Rrule">11.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">14.2 </td> </tr> <tr ID="id_7e128f66-0272-4d0a-827c-ff3444239b26"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Traumatic Bone Fracture </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.4 </td> </tr> <tr ID="id_6b53d6ae-6c02-4522-9491-93c3f515ffdb"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Myalgia </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.2 </td> </tr> <tr ID="id_154edc21-c8ee-4bcf-a16e-169e24db3c5b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Arthritis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.1 </td> </tr> <tr ID="id_06b90831-a961-4b4b-823f-683faa91020b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bursitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_33521cd4-8794-4d34-84e6-943b868cc3af"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bone Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.4 </td> </tr> <tr ID="id_ee6ec62d-d47a-488c-87b8-2262f5186a20"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Nervous System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_8ff38ca9-6cf2-47de-adba-6bf9487f3060"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dizziness </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_43952ac6-8769-4f6f-83cb-aaa943e7a18d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Anxiety </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.7 </td> </tr> <tr ID="id_8d9c11bb-bff4-4adc-97d3-15ff12609e0b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Depression </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> </tr> <tr ID="id_422c695d-3482-450f-92a4-55bb94577f95"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Vertigo </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_81a52b48-3944-413e-8b34-f4b1773c3ef7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Respiratory System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_c5023f66-8f88-4ba0-8ac4-63cd3351b872"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bronchitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_81d52278-4705-44ad-a44e-d35c74412291"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Sinusitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.5 </td> </tr> <tr ID="id_a4ad5853-757c-487b-a6f4-219974764f91"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pharyngitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td> </tr> <tr ID="id_d6ff8a7f-3a57-441f-936d-141de12f761e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Cough Increased </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_b7975338-22a6-495c-bb5a-e2c86ff0e1d7"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pneumonia </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td> </tr> <tr ID="id_13d13a75-b539-47d3-ac0a-7a7ae3f64a8e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rhinitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td> </tr> <tr ID="id_68000926-f176-4abe-b1a8-e285145efe59"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Skin and Appendages </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_9f4b3eb6-66a8-4c0c-8519-33b237d426b1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rash </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.1 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.1 </td> </tr> <tr ID="id_3a42cd3d-09bf-4800-b8a2-114118d94fe1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Pruritus </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.3 </td> </tr> <tr ID="id_b8f145e4-3204-47be-8572-87411a61c698"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Special Senses </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_bd7332e1-eacd-46bc-a837-d3d8a104dc4d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Cataract </td> <td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.9 </td> </tr> <tr ID="id_95eda380-0d53-4a9d-bf78-b1b7a20ff337"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Urogenital System </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_f9aba57d-98a0-47b0-9c3b-e98eda324ce1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Urinary Tract Infection </td> <td align="center" valign="top" styleCode="Rrule">2.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">5.2 </td> </tr> </tbody> </table>

<table border="1" width="439" ID="inv-15b3c583-c237-4fb8-a6ad-e05b236767ab"> <caption ID="inv-2ddad44d-59c5-4137-9c2c-d44f0947f607">Table 7: Adverse Events Reported in &#x2265; 2% of Risedronate-Treated Patients<footnote ID="id-9de7661b-f678-4729-82bc-4ab736545b0d">Considered to be possibly or probably causally related in at least one patient.</footnote> in Phase 3 Paget&#x2019;s Disease Trials</caption> <col width="33.7%"/> <col width="32.6%"/> <col width="33.7%"/> <tbody> <tr ID="id_2625be30-fd08-41f9-a0e0-c49066925470"> <td align="left" valign="bottom" styleCode="Botrule Toprule Rrule Lrule">Body System </td> <td align="center" valign="top" styleCode="Botrule Rrule">30 mg/day times 2 months Risedronate Sodium Tablets % (n = 61) </td> <td align="center" valign="top" styleCode="Botrule Rrule">400 mg/day times 6 months Etidronate Disodium Tablets % (n = 61) </td> </tr> <tr ID="id_c6120234-8172-43fe-a22a-9d424cb010c5"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Body as a Whole </td> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_d1ebfb82-86f4-43a9-9d1d-077a1e2b0975"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Flu Syndrome </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_5fc90e33-7064-44ac-ae18-012fab81790a"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Chest Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_53bda3b4-98fc-449e-9c13-ec1311ff8104"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Asthenia </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.0 </td> </tr> <tr ID="id_33d0cd4c-d40e-4a00-938f-40eae1637dce"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Neoplasm </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_8ff3339c-6261-4bb6-8ebe-84d7499a0a99"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Gastrointestinal </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_fd6ef910-ac59-4316-b1a2-e8c4e13697b8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Diarrhea </td> <td align="center" valign="top" styleCode="Botrule Rrule">19.7 </td> <td align="center" valign="top" styleCode="Botrule Rrule">14.8 </td> </tr> <tr ID="id_b63e2534-0b86-435f-9a79-4c917944967e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Abdominal Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">11.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.2 </td> </tr> <tr ID="id_ffdd02e8-697b-4833-89f8-19b66d3978f1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nausea </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">9.8 </td> </tr> <tr ID="id_c0b9c3e4-04d0-4ce2-994b-019cb0943488"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Constipation </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.2 </td> </tr> <tr ID="id_cefda5d5-6160-45c0-8f98-0a46394aca37"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Belching </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_d58b1059-c92e-4394-b5a4-a79129b09288"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Colitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_1b25a933-4cc9-48c2-a91d-ed4adbe0fdcc"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Metabolic and Nutritional Disorders </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_3a0cddc4-411e-46a7-b157-70ec91b96ff1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Peripheral Edema </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.2 </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.6 </td> </tr> <tr ID="id_4e89db33-5abc-43ce-923a-2b8d6aa273e8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Musculoskeletal </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_73d2b3f9-a41d-441c-b91e-4c635142f58d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Arthralgia </td> <td align="center" valign="top" styleCode="Botrule Rrule">32.8 </td> <td align="center" valign="top" styleCode="Botrule Rrule">29.5 </td> </tr> <tr ID="id_5f2998ba-ae9c-42a4-a20d-abb6084ae158"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bone Pain </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_6a8ac805-0b12-40c9-a70e-833efbc66a68"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Leg Cramps </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_3c04966d-b738-4d6a-b382-3a75c88565c2"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Myasthenia </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.0 </td> </tr> <tr ID="id_2549f1aa-b922-41a7-bfbf-c20084ba11e6"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Nervous </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_9fab8b8c-8052-429f-9492-edd80f9fada4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Headache </td> <td align="center" valign="top" styleCode="Botrule Rrule">18.0 </td> <td align="center" valign="top" styleCode="Botrule Rrule">16.4 </td> </tr> <tr ID="id_043df469-aa2a-4b64-82f4-6ff304f7b92d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dizziness </td> <td align="center" valign="top" styleCode="Botrule Rrule">6.6 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_db153366-b916-419a-aac7-0612be59463c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Respiratory </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_8d003603-deb1-40fb-aa8c-ad1607e6f1a0"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Bronchitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> </tr> <tr ID="id_215d887c-b9ad-4d39-b06c-d8e266b41688"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Sinusitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4.9 </td> <td align="center" valign="top" styleCode="Botrule Rrule">1.6 </td> </tr> <tr ID="id_81227f24-7e1b-47b7-b425-0f5706cba86b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Skin and Appendages </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_cda9db88-3a5f-490f-979e-25de14e9677e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rash </td> <td align="center" valign="top" styleCode="Botrule Rrule">11.5 </td> <td align="center" valign="top" styleCode="Botrule Rrule">8.2 </td> </tr> <tr ID="id_97b784ad-9f2d-42a5-ba0b-99de7a4f82d9"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Special Senses </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> </td> </tr> <tr ID="id_20857629-4dcf-46cc-b511-2b5636738523"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Amblyopia </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_eff7f7d8-7e7c-466a-ae79-2a6dc46b59fa"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Tinnitus </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">3.3 </td> </tr> <tr ID="id_f4f0aa89-0c3a-4c71-b631-dbe263c941fe"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dry Eye </td> <td align="center" valign="top" styleCode="Rrule">3.3 </td> <td align="center" valign="top" styleCode="Botrule Rrule">0.0 </td> </tr> </tbody> </table>