warnings
WARNINGS Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.
FDA label 2cfbca90-866b-4e06-a6a2-0f69f9bb1ced
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
- SPL set ID
- f6107154-0530-4e1f-93b0-6cb2277ef917
- SPL ID
- 2cfbca90-866b-4e06-a6a2-0f69f9bb1ced
- Version
- 3
- Effective date
- 2014-01-30
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:06:57
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 2cfbca90-866b-4e06-a6a2-0f69f9bb1ced | id | |
| spl set id | f6107154-0530-4e1f-93b0-6cb2277ef917 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions table
<table> <col width="31%"/> <col width="37%"/> <col width="33%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"> <paragraph>Adverse Event</paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule " valign="middle"> <paragraph>Ondansetron</paragraph> <paragraph>n = 336 Patients</paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule " valign="middle"> <paragraph>Placebo</paragraph> <paragraph>n = 334 Patients</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Pyrexia</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>14 (4%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>14 (4%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Bronchospasm</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>2 (<1%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>6 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Post-procedural pain</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>4 (1%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>6 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="middle"> <paragraph>Diarrhea</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>6 (2%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>3 (<1%)</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.