Home FDA labels 6cfbb5fe-940b-4ff1-89a7-e1dfc42b235b Fulvestrant openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Fulvestrant
Generic name FULVESTRANT
Manufacturer Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 46086fe7-190d-4963-97bc-1fe22d36e6d2
SPL ID 6cfbb5fe-940b-4ff1-89a7-e1dfc42b235b
Version 6
Effective date 2025-12-23
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. ( 5.1 ) Increased Exposure in Patients with Hepatic Impairment: Use a 250 mg dose for patients with moderate hepatic impairment. ( 2.2 , 5.2 , 8.6 ) Injection Site Reaction: Use caution while administering fulvestrant injection at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) Immunoassay Measurement of Serum Estradiol: fulvestrant injection can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels. ( 5.5 ) 5.1 Risk of Bleeding Because fulvestrant injection is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. 5.2 Increased Exposure in Patients with Hepatic Impairment The safety and pharmacokinetics of fulvestrant injection were evaluated in a study in seven subjects with moderate hepatic impairment (Child-Pugh class B) and seven subjects with normal hepatic function. Exposure was increased in patients with moderate hepatic impairment, therefore, a dose of 250 mg is recommended [see Dosage and Administration ( 2.2 )]. Fulvestrant injection has not been studied in patients with severe hepatic impairment (Child-Pugh class C) [see Use in Specific Populations ( 8.6 )]. 5.3 Injection Site Reaction Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection. Caution should be taken while administering fulvestrant injection at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve [see Dosage and Administration ( 2.3 ) and Adverse Reactions ( 6.1 )]. 5.4 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, fulvestrant can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with fulvestrant injection and for one year after the last dose [see Use in Specific Populations ( 8.1 ), ( 8.3 ) and Clinical Pharmacology ( 12.1 )]. 5.5 Immunoassay Measurement of Serum Estradiol Due to structural similarity of fulvestrant and estradiol, fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.
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adverse reactions table <table ID="t4" width="100%"><caption>Table 4: Adverse Reactions in Studies 0020 and 0021 (≥5% from Combined Data) </caption><col width="35.833%" align="left"/><col width="32.000%" align="left"/><col width="32.167%" align="left"/><tfoot><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote"><sup>1.</sup> Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. All patients on fulvestrant received injections, but only those anastrozole patients who were in Study 0021 received placebo injections. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="middle" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reactions</content></td><td align="center" valign="middle" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fulvestrant 250 mg</content> <content styleCode="bold">N=423</content> <content styleCode="bold">%</content></td><td align="center" valign="middle" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Anastrozole 1 mg</content> <content styleCode="bold">N=423</content> <content styleCode="bold">%</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Body as a Whole</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">68 </td><td align="center" valign="middle" styleCode="Botrule Rrule">68 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Asthenia </td><td align="center" valign="middle" styleCode="Botrule Rrule">23 </td><td align="center" valign="middle" styleCode="Botrule Rrule">27 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">19 </td><td align="center" valign="middle" styleCode="Botrule Rrule">20 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Headache </td><td align="center" valign="middle" styleCode="Botrule Rrule">15 </td><td align="center" valign="middle" styleCode="Botrule Rrule">17 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Back Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">14 </td><td align="center" valign="middle" styleCode="Botrule Rrule">13 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Abdominal Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Injection Site Pain<sup>1</sup></td><td align="center" valign="middle" styleCode="Botrule Rrule">11 </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pelvic Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Chest Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Flu Syndrome </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Fever </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Accidental Injury </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Cardiovascular System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">30 </td><td align="center" valign="middle" styleCode="Botrule Rrule">28 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vasodilatation </td><td align="center" valign="middle" styleCode="Botrule Rrule">18 </td><td align="center" valign="middle" styleCode="Botrule Rrule">17 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Digestive System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">52 </td><td align="center" valign="middle" styleCode="Botrule Rrule">48 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nausea </td><td align="center" valign="middle" styleCode="Botrule Rrule">26 </td><td align="center" valign="middle" styleCode="Botrule Rrule">25 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vomiting </td><td align="center" valign="middle" styleCode="Botrule Rrule">13 </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Constipation </td><td align="center" valign="middle" styleCode="Botrule Rrule">13 </td><td align="center" valign="middle" styleCode="Botrule Rrule">11 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Diarrhea </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td><td align="center" valign="middle" styleCode="Botrule Rrule">13 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anorexia </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td><td align="center" valign="middle" styleCode="Botrule Rrule">11 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Hemic and Lymphatic Systems</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">14 </td><td align="center" valign="middle" styleCode="Botrule Rrule">14 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anemia </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Metabolic and Nutritional Disorders</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">18 </td><td align="center" valign="middle" styleCode="Botrule Rrule">18 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Peripheral Edema </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Musculoskeletal System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">26 </td><td align="center" valign="middle" styleCode="Botrule Rrule">28 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Bone Pain </td><td align="center" valign="middle" styleCode="Botrule Rrule">16 </td><td align="center" valign="middle" styleCode="Botrule Rrule">14 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Arthritis </td><td align="center" valign="middle" styleCode="Botrule Rrule">3 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Nervous System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">34 </td><td align="center" valign="middle" styleCode="Botrule Rrule">34 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dizziness </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Insomnia </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Paresthesia </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">8 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Depression </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anxiety </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td><td align="center" valign="middle" styleCode="Botrule Rrule">4 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Respiratory System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">39 </td><td align="center" valign="middle" styleCode="Botrule Rrule">34 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pharyngitis </td><td align="center" valign="middle" styleCode="Botrule Rrule">16 </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dyspnea </td><td align="center" valign="middle" styleCode="Botrule Rrule">15 </td><td align="center" valign="middle" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Cough Increased </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Skin and Appendages</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">22 </td><td align="center" valign="middle" styleCode="Botrule Rrule">23 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Rash </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="middle" styleCode="Botrule Rrule">8 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Sweating </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td><td align="center" valign="middle" styleCode="Botrule Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Urogenital System</content></td><td align="center" valign="middle" styleCode="Botrule Rrule">18 </td><td align="center" valign="middle" styleCode="Botrule Rrule">15 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Urinary Tract Infection </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">4 </td></tr></tbody></table>
adverse reactions table <table ID="t5" width="100%"><caption>Table 5: Adverse Reactions (≥10%) in PALOMA-3 </caption><col width="24.029%" align="left"/><col width="14.829%" align="left"/><col width="11.571%" align="left"/><col width="11.571%" align="left"/><col width="14.843%" align="left"/><col width="11.600%" align="left"/><col width="11.557%" align="left"/><tfoot><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote">Grading according to CTCAE v.4.0. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote">CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>1.</sup> Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>2.</sup> Most common infections (≥1%) include: nasopharyngitis, upper respiratory infection, urinary tract infection, influenza, bronchitis, rhinitis, conjunctivitis, pneumonia, sinusitis, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, paronychia. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>3.</sup> Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>4.</sup> Grade 1 events – 17%; Grade 2 events – 1%. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>5.</sup> Grade 1 events – 6%. </paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote"><sup>6.</sup> Rash includes: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, toxic skin eruption. </paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="left" valign="middle" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reactions</content></td><td colspan="3" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fulvestrant plus Palbociclib</content> <content styleCode="bold">N=345</content></td><td colspan="3" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fulvestrant plus Placebo</content> <content styleCode="bold">N=172</content></td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Infections and Infestations</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Infections<sup>1</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">47<sup>2</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">31 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Blood and Lymphatic System Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Neutropenia </td><td align="center" valign="top" styleCode="Botrule Rrule">83 </td><td align="center" valign="top" styleCode="Botrule Rrule">55 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Leukopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">53 </td><td align="center" valign="top" styleCode="Botrule Rrule">30 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anemia </td><td align="center" valign="top" styleCode="Botrule Rrule">30 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Thrombocytopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">23 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Metabolism and Nutrition Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Decreased appetite </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Gastrointestinal Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nausea </td><td align="center" valign="top" styleCode="Botrule Rrule">34 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">28 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Stomatitis<sup>3</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">28 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Diarrhea </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">19 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">19 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Alopecia </td><td align="center" valign="top" styleCode="Botrule Rrule">18<sup>4</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">N/A </td><td align="center" valign="top" styleCode="Botrule Rrule">N/A </td><td align="center" valign="top" styleCode="Botrule Rrule">6<sup>5</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">N/A </td><td align="center" valign="top" styleCode="Botrule Rrule">N/A </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Rash<sup>6</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">17 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="7" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Fatigue </td><td align="center" valign="top" styleCode="Botrule Rrule">41 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pyrexia </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule"><1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>
adverse reactions table <table ID="t6" width="100%"><caption>Table 6: Laboratory Abnormalities in PALOMA-3 </caption><col width="35.514%" align="left"/><col width="12.357%" align="left"/><col width="9.986%" align="left"/><col width="10.000%" align="left"/><col width="12.157%" align="left"/><col width="9.986%" align="left"/><col width="10.000%" align="left"/><tfoot><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="footnote">N=number of patients; WBC=white blood cells. </paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="left" valign="middle" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Laboratory Parameters</content></td><td colspan="3" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fulvestrant plus Palbociclib N=345</content></td><td colspan="3" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fulvestrant plus Placebo N=172</content></td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">WBC decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">99 </td><td align="center" valign="top" styleCode="Botrule Rrule">45 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">26 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Neutrophils decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">96 </td><td align="center" valign="top" styleCode="Botrule Rrule">56 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anemia </td><td align="center" valign="top" styleCode="Botrule Rrule">78 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">40 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Platelets decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">62 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Aspartate aminotransferase increased </td><td align="center" valign="top" styleCode="Botrule Rrule">43 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">48 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Alanine aminotransferase increased </td><td align="center" valign="top" styleCode="Botrule Rrule">36 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">34 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>
adverse reactions table <table ID="t7" width="100%"><caption>Table 7: Adverse Reactions ≥10% of Patients Receiving Fulvestrant Plus Abemaciclib and ≥2% Higher Than Fulvestrant Plus Placebo in MONARCH 2 </caption><colgroup><col width="31.181%" align="left"/><col width="13.098%" align="left"/><col width="10.399%" align="left"/><col width="10.856%" align="left"/><col width="12.884%" align="left"/><col width="10.341%" align="left"/><col width="11.241%" align="left"/></colgroup><tfoot><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>1.</sup> Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, abdominal tenderness.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>2.</sup> Includes upper respiratory tract infection, urinary tract infection, lung infection, pharyngitis, conjunctivitis, sinusitis, vaginal infection, sepsis.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>3.</sup> Includes neutropenia, neutrophil count decreased.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>4.</sup> Includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>5.</sup> Includes leukopenia, white blood cell count decreased.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>6.</sup> Includes platelet count decreased, thrombocytopenia.</paragraph></td></tr><tr><td colspan="7" align="left" valign="top"><paragraph styleCode="First Footnote"><sup>7.</sup> Includes asthenia, fatigue.</paragraph></td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule" rowspan="2" align="left" valign="middle"><content styleCode="bold">Adverse Reactions</content></td><td styleCode="Botrule Rrule Toprule" colspan="3" align="center" valign="top"><content styleCode="bold">Fulvestrant plus Abemaciclib N=441</content></td><td styleCode="Botrule Rrule Toprule" colspan="3" align="center" valign="top"><content styleCode="bold">Fulvestrant plus Placebo</content> <content styleCode="bold">N=223</content></td></tr><tr><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">All Grades</content> <content styleCode="bold">%</content></td><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">Grade 3</content> <content styleCode="bold">%</content></td><td styleCode="Botrule Rrule" align="center" valign="top"><content styleCode="bold">Grade 4</content> <content styleCode="bold">%</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Gastrointestinal Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Diarrhea</td><td styleCode="Botrule Rrule" align="center" valign="top">86</td><td styleCode="Botrule Rrule" align="center" valign="top">13</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">25</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Nausea</td><td styleCode="Botrule Rrule" align="center" valign="top">45</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">23</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Abdominal pain<sup>1</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">35</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">16</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Vomiting</td><td styleCode="Botrule Rrule" align="center" valign="top">26</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">10</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Stomatitis</td><td styleCode="Botrule Rrule" align="center" valign="top">15</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">10</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Infections and Infestations</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Infections<sup>2</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">43</td><td styleCode="Botrule Rrule" align="center" valign="top">5</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">25</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Blood and Lymphatic System Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Neutropenia<sup>3</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">46</td><td styleCode="Botrule Rrule" align="center" valign="top">24</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">4</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Anemia<sup>4</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">29</td><td styleCode="Botrule Rrule" align="center" valign="top">7</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">4</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Leukopenia<sup>5</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">28</td><td styleCode="Botrule Rrule" align="center" valign="top">9</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Thrombocytopenia<sup>6</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">16</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Fatigue<sup>7</sup></td><td styleCode="Botrule Rrule" align="center" valign="top">46</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">32</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Edema peripheral</td><td styleCode="Botrule Rrule" align="center" valign="top">12</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">7</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Pyrexia</td><td styleCode="Botrule Rrule" align="center" valign="top">11</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">6</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Metabolism and Nutrition Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Decreased appetite</td><td styleCode="Botrule Rrule" align="center" valign="top">27</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">12</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Respiratory, Thoracic, and Mediastinal Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Cough</td><td styleCode="Botrule Rrule" align="center" valign="top">13</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">11</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Alopecia</td><td styleCode="Botrule Rrule" align="center" valign="top">16</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Pruritus</td><td styleCode="Botrule Rrule" align="center" valign="top">13</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">6</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Rash</td><td styleCode="Botrule Rrule" align="center" valign="top">11</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">4</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Nervous System Disorders</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Headache</td><td styleCode="Botrule Rrule" align="center" valign="top">20</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">15</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Dysgeusia</td><td styleCode="Botrule Rrule" align="center" valign="top">18</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Dizziness</td><td styleCode="Botrule Rrule" align="center" valign="top">12</td><td styleCode="Botrule Rrule" align="center" valign="top">1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">6</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="7" align="left" valign="top"><content styleCode="bold">Investigations</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Alanine aminotransferase increased</td><td styleCode="Botrule Rrule" align="center" valign="top">13</td><td styleCode="Botrule Rrule" align="center" valign="top">4</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">5</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Aspartate aminotransferase increased</td><td styleCode="Botrule Rrule" align="center" valign="top">12</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">7</td><td styleCode="Botrule Rrule" align="center" valign="top">3</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Creatinine increased</td><td styleCode="Botrule Rrule" align="center" valign="top">12</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left" valign="top">Weight decreased</td><td styleCode="Botrule Rrule" align="center" valign="top">10</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td><td styleCode="Botrule Rrule" align="center" valign="top">2</td><td styleCode="Botrule Rrule" align="center" valign="top"><1</td><td styleCode="Botrule Rrule" align="center" valign="top">0</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.