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warnings WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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adverse reactions ADVERSE REACTIONS Adult Patients: Fenoldopam causes a dose-related fall in blood pressure and increase in heart rate (see Precautions, Tachycardia, and Hypotension). In controlled clinical studies of severe hypertension in patients with end-organ damage, 3% (4/137) of patients withdrew because of excessive falls in blood pressure. Increased heart rate could, in theory, lead to ischemic cardiac events or worsened heart failure, although these events have not been observed. The most common events reported as associated with fenoldopam use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients. Adverse reactions in controlled trials in hypertensive adult patients Adverse events occurring more than once in any dosing group (once if potentially important or plausibly drug-related) in the fixed-dose constant-infusion studies are presented in the following Table by infusion-rate group. There was no clear dose relationship, except possibly for headache, nausea, flushing. Table 4 ADVERSE EVENTS* FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP Body System Fenoldopam Dosage (mcg/kg/min)(Adults) Event Placebo (n = 7) 0.01 (n = 26) 0.03 to 0.04 (n = 31) 0.1 (n = 28) 0.3 to 0.4 (n = 29) 0.6 to 0.8 (n = 11) *Includes events reported by 2 or more patients receiving fenoldopam treatment across all dose groups. **Investigator defined; no protocol definition. Body, General Headache 1 5 4 7 8 6 Injection site reaction 0 1 3 0 3 2 Cardiovascular ST-T abnormalities (primarily T-wave inversion) 0 2 4 0 1 0 Flushing 0 0 0 0 1 3 Hypotension** 0 0 0 2 0 2 Postural hypotension 0 2 0 0 0 0 Tachycardia** 0 0 0 0 0 2 Digestive Nausea 0 3 0 3 5 4 Vomiting 0 2 0 2 1 2 Abdominal pain/ fullness 0 2 0 0 2 1 Constipation 0 0 0 0 0 2 Diarrhea 0 0 0 0 2 0 Metabolic and Nutritional Increased creatinine** 0 0 2 0 0 0 Hypokalemia** 0 2 2 0 1 0 Nervous Nervousness/ anxiety 0 0 1 0 0 2 Insomnia 0 2 0 0 0 0 Dizziness 0 1 1 2 2 0 Respiratory Nasal congestion 0 0 0 0 0 2 Skin and Appendages Sweating 0 0 0 1 1 2 Urogenital Urinary tract infection 0 2 0 1 0 0 Musculoskeletal Back pain 0 1 0 1 2 2 Adverse effects in overall data base The adverse event incidences listed below are based on observations of over 1,000 fenoldopam treated adult patients and not listed in Table 4 above. Events reported with a frequency between 0.5 to 5% in patients treated with IV fenoldopam Cardiovascular: extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris Metabolic: elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH General Body: non-specific chest pain, pyrexia Hematologic/Lymphatic: leukocytosis, bleeding Respiratory: dyspnea, upper respiratory disorder Genitourinary: oliguria Musculoskeletal: limb cramp Pediatric Patients: In pediatric patients, the most common adverse events reported during short-term administration in controlled trials (30 minutes) were hypotension and tachycardia. However, because of the short exposure, there is limited experience with defining adverse events in children. The long-term effects of fenoldopam on growth and development have not been studied.
adverse reactions table <table> <caption>Table 4 ADVERSE EVENTS* FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP</caption> <colgroup> <col/> <col/> <col/> <col/> <col/> <col/> <col/> <col/> </colgroup> <thead styleCode="Lrule Rrule Toprule Botrule"> <tr> <th styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">Body System</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" colspan="7" align="center" valign="top"> <content styleCode="bold"> <content styleCode="emphasis">Fenoldopam Dosage (mcg/kg/min)(Adults)</content> </content> </th> </tr> <tr> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">Event </content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">Placebo </content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 7)</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">0.01 </content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 26)</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">0.03 to 0.04</content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 31) </content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">0.1</content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 28)</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">0.3 to 0.4</content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 29)</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"> <content styleCode="bold"> <content styleCode="emphasis">0.6 to 0.8</content> </content> <content styleCode="bold"> <content styleCode="emphasis">(n = 11)</content> </content> </th> </tr> </thead> <tfoot> <tr> <td colspan="8" valign="top"> <paragraph/>*Includes events reported by 2 or more patients receiving fenoldopam treatment across all dose groups.<paragraph>**Investigator defined; no protocol definition. </paragraph> </td> </tr> </tfoot> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>Body, General</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Headache</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>4</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>8</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Injection site</paragraph> <paragraph>reaction</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="5" valign="top"> <paragraph>Cardiovascular</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>ST-T</paragraph> <paragraph>abnormalities</paragraph> <paragraph>(primarily T-wave</paragraph> <paragraph>inversion)</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>4</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Flushing</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Hypotension**</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Postural</paragraph> <paragraph>hypotension</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Tachycardia**</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="5" valign="top"> <paragraph>Digestive</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Nausea</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>4</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Vomiting</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Abdominal pain/</paragraph> <paragraph>fullness</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Constipation</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Diarrhea</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>Metabolic and</paragraph> <paragraph>Nutritional</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Increased</paragraph> <paragraph>creatinine**</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Hypokalemia**</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="3" valign="top"> <paragraph>Nervous</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Nervousness/ anxiety</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Insomnia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Dizziness</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>Respiratory</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Nasal congestion</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>Skin and</paragraph> <paragraph>Appendages</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Sweating</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>Urogenital</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Urinary tract</paragraph> <paragraph>infection</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>Musculoskeletal </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>Back pain</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>0</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table> <caption/> <colgroup> <col/> <col/> </colgroup> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Cardiovascular:</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Metabolic:</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">General Body:</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>non-specific chest pain, pyrexia</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Hematologic/Lymphatic: </content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>leukocytosis, bleeding</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Respiratory:</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>dyspnea, upper respiratory disorder</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Genitourinary:</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>oliguria</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="italics"> <content styleCode="emphasis">Musculoskeletal: </content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>limb cramp</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.