Home FDA labels 2ebb3138-1d60-4046-880f-296c36abebe5 FDA label 2ebb3138-1d60-4046-880f-296c36abebe5 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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Effective date 2014-03-19
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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 mesylate 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 mesylate 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 Includes events reported by 2 or more patients receiving fenoldopam mesylate treatment across all dose groups. FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP Fenoldopam Mesylate Dosage (mcg/kg/min) (Adults) Body System Event Placebo (n=7) 0.01 (n=26) 0.03-0.04 (n=31) 0.1 (n=28) 0.3-0.4 (n=29) 0.6-0.8 (n=11) Body, General Headache 1 5 4 7 8 6 Injection site reaction 0 1 3 0 3 2 Cardiovascular ST-T abnormalitites (primarily T-wave inversion) 0 2 4 0 1 0 Flushing 0 0 0 0 1 3 Hypotension Investigator defined; no protocol definition. 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 database The adverse event incidences listed below are based on observations of over 1,000 fenoldopam mesylate treated adult patients and not listed in the Table 4 above. Events reported with a frequency between 0.5 to 5% in patients treated with IV fenoldopam mesylate 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 ID="_Refid_bb085e58-670e-4ae7-a85b-b212e2def"> <caption>Table 4 ADVERSE EVENTS<footnote ID="_Refid-a3394098-6900-4550-baf5-2ba20b53e">Includes events reported by 2 or more patients receiving fenoldopam mesylate treatment across all dose groups.</footnote> FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP</caption> <col width="19%"/> <col width="22%"/> <col width="14%"/> <col width="9%"/> <col width="10%"/> <col width="10%"/> <col width="9%"/> <col width="9%"/> <tbody> <tr> <td styleCode="Toprule "/> <td align="center" colspan="7" styleCode="Toprule "> <paragraph> <content styleCode="bold">Fenoldopam Mesylate Dosage (mcg/kg/min) (Adults)</content> </paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="bold">Body System</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">Event</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(n=7)</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">0.01</content> </paragraph> <paragraph> <content styleCode="bold">(n=26)</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">0.03-0.04</content> </paragraph> <paragraph> <content styleCode="bold">(n=31)</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">0.1</content> </paragraph> <paragraph> <content styleCode="bold">(n=28)</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">0.3-0.4</content> </paragraph> <paragraph> <content styleCode="bold">(n=29)</content> </paragraph> </td> <td align="center"> <paragraph> <content styleCode="bold">0.6-0.8</content> </paragraph> <paragraph> <content styleCode="bold">(n=11)</content> </paragraph> </td> </tr> <tr> <td rowspan="2"> <paragraph>Body, General</paragraph> </td> <td align="center"> <paragraph>Headache</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>5</paragraph> </td> <td align="center"> <paragraph>4</paragraph> </td> <td align="center"> <paragraph>7</paragraph> </td> <td align="center"> <paragraph>8</paragraph> </td> <td align="center"> <paragraph>6</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Injection site reaction</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>3</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>3</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td rowspan="5"> <paragraph>Cardiovascular</paragraph> </td> <td align="center"> <paragraph>ST-T abnormalitites (primarily T-wave inversion)</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>4</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Flushing</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>3</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Hypotension<footnote ID="_Refid-52fb7bd2-afd3-4047-8046-fc000524a">Investigator defined; no protocol definition.</footnote> </paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Postural hypotension</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Tachycardia<footnoteRef IDREF="_Refid-52fb7bd2-afd3-4047-8046-fc000524a"/> </paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td rowspan="5"> <paragraph>Digestive</paragraph> </td> <td align="center"> <paragraph>Nausea</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>3</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>3</paragraph> </td> <td align="center"> <paragraph>5</paragraph> </td> <td align="center"> <paragraph>4</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Vomiting</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Abdominal pain/fullness</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Constipation</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Diarrhea</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td rowspan="2"> <paragraph>Metabolic and Nutritional</paragraph> </td> <td align="center"> <paragraph>Increased creatinine<footnoteRef IDREF="_Refid-52fb7bd2-afd3-4047-8046-fc000524a"/> </paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Hypokalemia<footnoteRef IDREF="_Refid-52fb7bd2-afd3-4047-8046-fc000524a"/> </paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td rowspan="3"> <paragraph>Nervous</paragraph> </td> <td align="center"> <paragraph>Nervousness/anxiety</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Insomnia</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td align="center"> <paragraph>Dizziness</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td> <paragraph>Respiratory</paragraph> </td> <td align="center"> <paragraph>Nasal congestion</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td> <paragraph>Skin and Appendages</paragraph> </td> <td align="center"> <paragraph>Sweating</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td> <paragraph>Urogenital</paragraph> </td> <td align="center"> <paragraph>Urinary tract infection</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>2</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>1</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> <td align="center"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Botrule "> <paragraph>Musculoskeletal</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>Back pain</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table> <col width="38%"/> <col width="63%"/> <tbody> <tr> <td styleCode="Toprule "> <paragraph> <content styleCode="italics">Cardiovascular:</content> </paragraph> </td> <td styleCode="Toprule "> <paragraph>extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris</paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="italics">Metabolic:</content> </paragraph> </td> <td> <paragraph>elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH</paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="italics">General Body:</content> </paragraph> </td> <td> <paragraph>non-specific chest pain, pyrexia</paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="italics">Hematologic/Lymphatic:</content> </paragraph> </td> <td> <paragraph>leukocytosis, bleeding</paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="italics">Respiratory:</content> </paragraph> </td> <td> <paragraph>dyspnea, upper respiratory disorder</paragraph> </td> </tr> <tr> <td> <paragraph> <content styleCode="italics">Genitourinary:</content> </paragraph> </td> <td> <paragraph>oliguria</paragraph> </td> </tr> <tr> <td styleCode="Botrule "> <paragraph> <content styleCode="italics">Musculoskeletal:</content> </paragraph> </td> <td styleCode="Botrule "> <paragraph>limb cramp</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.