FDA label 8bd7d538-dc56-40fc-a19d-83d013295cc7

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
599ec9d1-281f-4693-b9a0-9778df41ae15
SPL ID
8bd7d538-dc56-40fc-a19d-83d013295cc7
Version
11
Effective date
2015-02-05
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:49

Warnings cross-check#

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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.

Adverse reactions cross-check#

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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 EVENTS1 FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP Fenoldopam 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 abnormalities (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 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 ID="_Ref318711732"> <caption>Table 4 ADVERSE EVENTS1 FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP</caption> <col width="19%"/> <col width="24%"/> <col width="18%"/> <col width="7%"/> <col width="9%"/> <col width="8%"/> <col width="7%"/> <col width="8%"/> <tbody> <tr> <td styleCode="Rrule Lrule Toprule " valign="bottom"/> <td align="center" colspan="7" styleCode="Rrule Botrule Toprule " valign="bottom"> <paragraph> <content styleCode="bold">Fenoldopam</content> <content styleCode="bold"> Dosage (mcg/kg/min) (Adults)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Body System</content> </paragraph> </td> <td styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Event</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(n = 7)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">0.01</content> </paragraph> <paragraph> <content styleCode="bold">(n = 26)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">0.03-0.04</content> </paragraph> <paragraph> <content styleCode="bold">(n = 31)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">0.1</content> </paragraph> <paragraph> <content styleCode="bold">(n = 28)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">0.3-0.4</content> </paragraph> <paragraph> <content styleCode="bold">(n = 29)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">0.6-0.8</content> </paragraph> <paragraph> <content styleCode="bold">(n = 11)</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Body, General</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>8</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Injection site reaction</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td rowspan="5" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Cardiovascular</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>ST-T abnormalities</paragraph> <paragraph>(primarily T-wave</paragraph> <paragraph>inversion)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Flushing</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="bottom"> <paragraph>Hypotension<footnote ID="_RefID-DAE77AD6-31A9-4498-9CCF-E7999BEA8">Investigator defined; no protocol definition.</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Postural hypotension</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Tachycardia<footnoteRef IDREF="_RefID-DAE77AD6-31A9-4498-9CCF-E7999BEA8"/> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td rowspan="5" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Digestive</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Nausea</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>4</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Vomiting</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Abdominal pain/Fullness</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Constipation</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Diarrhea</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Metabolic and</paragraph> <paragraph>Nutritional</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Increased creatinine<footnoteRef IDREF="_RefID-DAE77AD6-31A9-4498-9CCF-E7999BEA8"/> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Hypokalemia<footnoteRef IDREF="_RefID-DAE77AD6-31A9-4498-9CCF-E7999BEA8"/> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td rowspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Nervous</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Nervousness/Anxiety</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Insomnia</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Respiratory</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Nasal congestion</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Skin and Appendages</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Sweating</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Urogenital</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Urinary tract infection</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Musculoskeletal</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Back pain</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="bottom"> <paragraph>2</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.