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warnings and cautions 5 WARNINGS AND PRECAUTIONS Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin. Discontinue caspofungin at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. ( 5.1 ) Hepatic Effects : Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function, and evaluate risk/benefit of continuing caspofungin. ( 5.2 ) Elevated Liver Enzymes During Concomitant Use with Cyclosporine : Limit use to patients for whom potential benefit outweighs potential risk. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with caspofungin. ( 5.3 ) 5.1 Hypersensitivity Anaphylaxis and other hypersensitivity reactions have been reported during administration of caspofungin. Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with a fatal outcome, have been reported with use of caspofungin [see Adverse Reactions ( 6.2 )] . Discontinue caspofungin at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. 5.2 Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and in adult and pediatric patients treated with caspofungin. In some adult and pediatric patients with serious underlying conditions who were receiving multiple concomitant medications with caspofungin, isolated cases of clinically significant hepatic dysfunction, hepatitis, and hepatic failure have been reported; a causal relationship to caspofungin has not been established. Monitor patients who develop abnormal liver function tests during caspofungin therapy for evidence of worsening hepatic function and evaluated for risk/benefit of continuing caspofungin therapy. 5.3 Elevated Liver Enzymes During Concomitant Use with Cyclosporine Elevated liver enzymes have occurred in patients receiving caspofungin and cyclosporine concomitantly. Only use caspofungin and cyclosporine in those patients for whom the potential benefit outweighs the potential risk. Patients who develop abnormal liver enzymes during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be evaluated.
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adverse reactions table <table ID="t5" width="100%"><caption>Table 5: Adverse Reactions Among Patients with Esophageal and/or Oropharyngeal Candidiasis Incidence 10% or Greater for at Least One Treatment Group </caption><col align="left" width="44.367%"/><col align="left" width="22.300%"/><col align="left" width="33.333%"/><tfoot><tr><td align="left" colspan="3" valign="top"><paragraph styleCode="footnote">Within any system organ class, individuals may experience more than 1 adverse reaction. </paragraph></td></tr><tr><td align="left" colspan="3" valign="top"><paragraph styleCode="footnote"><content styleCode="bold">*</content>Derived from a comparator-controlled clinical study. </paragraph></td></tr></tfoot><tbody><tr><td align="left" styleCode="Toprule Botrule" valign="top"> <content styleCode="bold">Adverse Reactions</content></td><td align="center" styleCode="Toprule Botrule" valign="top"><content styleCode="bold">Caspofungin</content> <content styleCode="bold">50 mg*</content> <content styleCode="bold">N=83 (%)</content></td><td align="center" styleCode="Toprule Botrule" valign="top"><content styleCode="bold">Fluconazole IV</content> <content styleCode="bold">200 mg*</content> <content styleCode="bold">N=94 (%)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">All Systems, Any Adverse Reaction</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">90</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">93</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Gastrointestinal Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">58</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">50</content></td></tr><tr><td align="left" valign="middle"> Diarrhea </td><td align="center" valign="middle">27 </td><td align="center" valign="middle">18 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Nausea </td><td align="center" styleCode="Botrule" valign="middle">15 </td><td align="center" styleCode="Botrule" valign="middle">15 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Investigations</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">53</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">61</content></td></tr><tr><td align="left" valign="middle"> Hemoglobin Decreased </td><td align="center" valign="middle">21 </td><td align="center" valign="middle">16 </td></tr><tr><td align="left" valign="middle"> Hematocrit Decreased </td><td align="center" valign="middle">18 </td><td align="center" valign="middle">16 </td></tr><tr><td align="left" valign="middle"> Aspartate Aminotransferase Increased </td><td align="center" valign="middle">13 </td><td align="center" valign="middle">19 </td></tr><tr><td align="left" valign="middle"> Blood Alkaline Phosphatase Increased </td><td align="center" valign="middle">13 </td><td align="center" valign="middle">17 </td></tr><tr><td align="left" valign="middle"> Alanine Aminotransferase Increased </td><td align="center" valign="middle">12 </td><td align="center" valign="middle">17 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> White Blood Cell Count Decreased </td><td align="center" styleCode="Botrule" valign="middle">12 </td><td align="center" styleCode="Botrule" valign="middle">19 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">31</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">36</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Pyrexia </td><td align="center" styleCode="Botrule" valign="middle">21 </td><td align="center" styleCode="Botrule" valign="middle">21 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Vascular Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">19</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">15</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Phlebitis </td><td align="center" styleCode="Botrule" valign="middle">18 </td><td align="center" styleCode="Botrule" valign="middle">11 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Nervous System Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">18</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">17</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Headache </td><td align="center" styleCode="Botrule" valign="middle">15 </td><td align="center" styleCode="Botrule" valign="middle">9 </td></tr></tbody></table>
adverse reactions table <table ID="t6" width="100%"><caption>Table 6: Adverse Reactions Among Pediatric Patients (0 months to 17 years of age) Incidence 7.5% or Greater for at Least One Treatment Group </caption><col align="left" width="35.900%"/><col align="left" width="21.625%"/><col align="left" width="18.800%"/><col align="left" width="23.675%"/><tfoot><tr><td align="left" colspan="4" valign="top"><paragraph styleCode="footnote">Within any system organ class, individuals may experience more than 1 adverse reaction. </paragraph></td></tr><tr><td align="left" colspan="4" valign="top"><paragraph styleCode="footnote"><content styleCode="bold">*</content>70 mg/m<sup>2</sup> on Day 1, then 50 mg/m<sup>2</sup> once daily for the remainder of the treatment. </paragraph></td></tr></tfoot><tbody><tr><td align="left" rowspan="2" styleCode="Toprule Botrule" valign="top"> <content styleCode="bold">Adverse Reactions</content></td><td align="center" styleCode="Toprule Botrule Rrule" valign="top"><content styleCode="bold">Noncomparative</content> <content styleCode="bold">Clinical Studies</content></td><td align="center" colspan="2" styleCode="Toprule Botrule" valign="top"><content styleCode="bold">Comparator-Controlled Clinical</content> <content styleCode="bold">Study of Empirical Therapy</content></td></tr><tr><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="bold">Caspofungin</content> <content styleCode="bold">Any Dose</content> <content styleCode="bold">N=115 (%)</content></td><td align="center" styleCode="Botrule" valign="top"><content styleCode="bold">Caspofungin</content> <content styleCode="bold">50 mg/m</content><content styleCode="bold"><sup>2</sup></content><content styleCode="bold">*</content> <content styleCode="bold">N=56 (%)</content></td><td align="center" styleCode="Botrule" valign="top"><content styleCode="bold">AmBisome</content> <content styleCode="bold">3 mg/kg</content> <content styleCode="bold">N=26 (%)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">All Systems, Any Adverse Reaction</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">95</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">96</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">89</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Investigations</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">55</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">41</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">50</content></td></tr><tr><td align="left" valign="middle"> Blood Potassium Decreased </td><td align="center" styleCode="Rrule" valign="middle">18 </td><td align="center" valign="middle">9 </td><td align="center" valign="middle">27 </td></tr><tr><td align="left" valign="middle"> Aspartate Aminotransferase Increased </td><td align="center" styleCode="Rrule" valign="middle">17 </td><td align="center" valign="middle">2 </td><td align="center" valign="middle">12 </td></tr><tr><td align="left" valign="middle"> Alanine Aminotransferase Increased </td><td align="center" styleCode="Rrule" valign="middle">14 </td><td align="center" valign="middle">5 </td><td align="center" valign="middle">12 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Blood Potassium Increased </td><td align="center" styleCode="Botrule Rrule" valign="middle">3 </td><td align="center" styleCode="Botrule" valign="middle">0 </td><td align="center" styleCode="Botrule" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">47</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">59</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">42</content></td></tr><tr><td align="left" valign="middle"> Pyrexia </td><td align="center" styleCode="Rrule" valign="middle">29 </td><td align="center" valign="middle">30 </td><td align="center" valign="middle">23 </td></tr><tr><td align="left" valign="middle"> Chills </td><td align="center" styleCode="Rrule" valign="middle">10 </td><td align="center" valign="middle">13 </td><td align="center" valign="middle">8 </td></tr><tr><td align="left" valign="middle"> Mucosal Inflammation </td><td align="center" styleCode="Rrule" valign="middle">10 </td><td align="center" valign="middle">4 </td><td align="center" valign="middle">4 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Edema </td><td align="center" styleCode="Botrule Rrule" valign="middle">3 </td><td align="center" styleCode="Botrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Gastrointestinal Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">42</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">41</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">35</content></td></tr><tr><td align="left" valign="middle"> Diarrhea </td><td align="center" styleCode="Rrule" valign="middle">17 </td><td align="center" valign="middle">7 </td><td align="center" valign="middle">15 </td></tr><tr><td align="left" valign="middle"> Vomiting </td><td align="center" styleCode="Rrule" valign="middle">8 </td><td align="center" valign="middle">11 </td><td align="center" valign="middle">12 </td></tr><tr><td align="left" valign="middle"> Abdominal Pain </td><td align="center" styleCode="Rrule" valign="middle">7 </td><td align="center" valign="middle">4 </td><td align="center" valign="middle">12 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Nausea </td><td align="center" styleCode="Botrule Rrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Infections and Infestations</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">40</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">30</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">35</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Central Line Infection </td><td align="center" styleCode="Botrule Rrule" valign="middle">1 </td><td align="center" styleCode="Botrule" valign="middle">9 </td><td align="center" styleCode="Botrule" valign="middle">0 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">33</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">41</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">39</content></td></tr><tr><td align="left" valign="middle"> Pruritus </td><td align="center" styleCode="Rrule" valign="middle">7 </td><td align="center" valign="middle">6 </td><td align="center" valign="middle">8 </td></tr><tr><td align="left" valign="middle"> Rash </td><td align="center" styleCode="Rrule" valign="middle">6 </td><td align="center" valign="middle">23 </td><td align="center" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Erythema </td><td align="center" styleCode="Botrule Rrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">9 </td><td align="center" styleCode="Botrule" valign="middle">0 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Vascular Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">24</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">21</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">19</content></td></tr><tr><td align="left" valign="middle"> Hypotension </td><td align="center" styleCode="Rrule" valign="middle">12 </td><td align="center" valign="middle">9 </td><td align="center" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Hypertension </td><td align="center" styleCode="Botrule Rrule" valign="middle">10 </td><td align="center" styleCode="Botrule" valign="middle">9 </td><td align="center" styleCode="Botrule" valign="middle">4 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Metabolism and Nutrition Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">22</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">11</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">23</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Hypokalemia </td><td align="center" styleCode="Botrule Rrule" valign="middle">8 </td><td align="center" styleCode="Botrule" valign="middle">5 </td><td align="center" styleCode="Botrule" valign="middle">4 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Cardiac Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">17</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">13</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">19</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Tachycardia </td><td align="center" styleCode="Botrule Rrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">11 </td><td align="center" styleCode="Botrule" valign="middle">19 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Nervous System Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">13</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">16</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">8</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Headache </td><td align="center" styleCode="Botrule Rrule" valign="middle">5 </td><td align="center" styleCode="Botrule" valign="middle">9 </td><td align="center" styleCode="Botrule" valign="middle">4 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Musculoskeletal and Connective Tissue Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">11</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">14</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">12</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Back Pain </td><td align="center" styleCode="Botrule Rrule" valign="middle">4 </td><td align="center" styleCode="Botrule" valign="middle">0 </td><td align="center" styleCode="Botrule" valign="middle">8 </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Blood and Lymphatic System Disorders</content></td><td align="center" styleCode="Botrule Rrule" valign="middle"><content styleCode="bold">10</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">2</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">15</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Anemia </td><td align="center" styleCode="Botrule Rrule" valign="middle">2 </td><td align="center" styleCode="Botrule" valign="middle">0 </td><td align="center" styleCode="Botrule" valign="middle">8 </td></tr></tbody></table>
adverse reactions table <table ID="t7" width="100%"><caption>Table 7: Adverse Reactions* in Patients Who Received Caspofungin in Clinical Trials<sup>†</sup> Incidence 5% or Greater for at Least One Treatment Group </caption><col align="left" width="44.367%"/><col align="left" width="28.200%"/><col align="left" width="27.433%"/><tfoot><tr><td align="left" colspan="3" valign="top"><paragraph styleCode="footnote"><content styleCode="bold">*</content>Defined as an adverse reaction, regardless of causality, while on caspofungin or during the 14-day post- caspofungin follow-up period. </paragraph></td></tr><tr><td align="left" colspan="3" valign="top"><paragraph styleCode="footnote"><content styleCode="bold"><sup>†</sup></content>Incidence for each preferred term is 5% or greater among individuals who received at least 1 dose of caspofungin. </paragraph></td></tr><tr><td align="left" colspan="3" valign="top"><paragraph styleCode="footnote"><content styleCode="bold"><sup>‡</sup></content>Within any system organ class, individuals may experience more than 1 adverse event. </paragraph></td></tr></tfoot><tbody><tr><td align="justify" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">Adverse Reactions</content><content styleCode="bold"><sup>‡</sup></content></td><td align="center" colspan="2" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">Caspofungin (N=1951)</content></td></tr><tr><td align="center" valign="middle"/><td align="center" valign="middle"><content styleCode="bold">n</content></td><td align="center" valign="middle"><content styleCode="bold">(%)</content></td></tr><tr><td align="left" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">All Systems, Any Adverse Reaction</content></td><td align="center" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">1665</content></td><td align="center" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">(85)</content></td></tr><tr><td align="left" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">Investigations</content></td><td align="center" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">901</content></td><td align="center" styleCode="Toprule Botrule" valign="middle"><content styleCode="bold">(46)</content></td></tr><tr><td align="left" valign="middle"> Alanine Aminotransferase Increased </td><td align="center" valign="middle">258 </td><td align="center" valign="middle">(13) </td></tr><tr><td align="left" valign="middle"> Aspartate Aminotransferase Increased </td><td align="center" valign="middle">233 </td><td align="center" valign="middle">(12) </td></tr><tr><td align="left" valign="middle"> Blood Alkaline Phosphatase Increased </td><td align="center" valign="middle">232 </td><td align="center" valign="middle">(12) </td></tr><tr><td align="left" valign="middle"> Blood Potassium Decreased </td><td align="center" valign="middle">220 </td><td align="center" valign="middle">(11) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Blood Bilirubin Increased </td><td align="center" styleCode="Botrule" valign="middle">117 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">843</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(43)</content></td></tr><tr><td align="left" valign="middle"> Pyrexia </td><td align="center" valign="middle">381 </td><td align="center" valign="middle">(20) </td></tr><tr><td align="left" valign="middle"> Chills </td><td align="center" valign="middle">192 </td><td align="center" valign="middle">(10) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Edema Peripheral </td><td align="center" styleCode="Botrule" valign="middle">110 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Gastrointestinal Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">754</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(39)</content></td></tr><tr><td align="left" valign="middle"> Diarrhea </td><td align="center" valign="middle">273 </td><td align="center" valign="middle">(14) </td></tr><tr><td align="left" valign="middle"> Nausea </td><td align="center" valign="middle">166 </td><td align="center" valign="middle">(9) </td></tr><tr><td align="left" valign="middle"> Vomiting </td><td align="center" valign="middle">146 </td><td align="center" valign="middle">(8) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Abdominal Pain </td><td align="center" styleCode="Botrule" valign="middle">112 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Infections and Infestations</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">730</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(37)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Pneumonia </td><td align="center" styleCode="Botrule" valign="middle">115 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Respiratory, Thoracic, and Mediastinal Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">613</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(31)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Cough </td><td align="center" styleCode="Botrule" valign="middle">111 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">520</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(27)</content></td></tr><tr><td align="left" valign="middle"> Rash </td><td align="center" valign="middle">159 </td><td align="center" valign="middle">(8) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Erythema </td><td align="center" styleCode="Botrule" valign="middle">98 </td><td align="center" styleCode="Botrule" valign="middle">(5) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Nervous System Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">412</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(21)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Headache </td><td align="center" styleCode="Botrule" valign="middle">193 </td><td align="center" styleCode="Botrule" valign="middle">(10) </td></tr><tr><td align="left" styleCode="Botrule" valign="middle"><content styleCode="bold">Vascular Disorders</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">344</content></td><td align="center" styleCode="Botrule" valign="middle"><content styleCode="bold">(18)</content></td></tr><tr><td align="left" styleCode="Botrule" valign="middle"> Hypotension </td><td align="center" styleCode="Botrule" valign="middle">118 </td><td align="center" styleCode="Botrule" valign="middle">(6) </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.