openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT 3 receptor antagoinist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of granisetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue granisetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if granisetron is used concomitantly with other serotonergic drugs (see Drug Interactions and Patient Counseling Information ).
ADVERSE REACTIONS QT prolongation has been reported with granisetron (see PRECAUTIONS and Drug Interactions ) . Chemotherapy-Induced Nausea and Vomiting Over 3700 patients have received granisetron tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens. In patients receiving granisetron tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4 . Table 4: Principal Adverse Events in Clinical Trials Percent of Patients with Event Granisetron Hydrochloride Tablets Adverse events were recorded for 7 days when granisetron tablets were give on a single day and for up to 28 days when granisetron tablets were administered for 7 or 14 days. 1 mg twice a day (N=978) Granisetron Hydrochloride Tablets 2 mg once a day (N=1450) Comparator Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine. (N=599) Placebo (N=185) Headache Usually mild to moderate in severity. 21% 20% 13% 12% Constipation 18% 14% 16% 8% Asthenia 14% 18% 10% 4% Diarrhea 8% 9% 10% 4% Abdominal Pain 6% 4% 6% 3% Dyspepsia 4% 6% 5% 4% Other adverse events reported in clinical trials were: Gastrointestinal: In single-day dosing studies in which adverse events were collected for 7 days, nausea (20%) and vomiting (12%) were recorded as adverse events after the 24-hour efficacy assessment period. Hepatic: In comparative trials, elevation of AST and ALT (>2 times the upper limit of normal) following the administration of granisetron tablets occurred in 5% and 6% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2%; ALT: 9%). Cardiovascular: Hypertension (1%); hypotension, angina pectoris, atrial fibrillation, and syncope have been observed rarely. Central Nervous System: Dizziness (5%), insomnia (5%), anxiety (2%), somnolence (1%). One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported in a patient treated with granisetron tablets. Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported. Other: Fever (5%). Events often associated with chemotherapy also have been reported: leukopenia (9%), decreased appetite (6%), anemia (4%), alopecia (3%), thrombocytopenia (2%). Over 5000 patients have received injectable granisetron in clinical trials. Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥3%) in patients receiving granisetron injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following granisetron injection administration. Table 5: Principal Adverse Events in Clinical Trials - Single-Day Chemotherapy Percent of Patients with Event Granisetron Hydrochloride Injection Adverse events were generally recorded over 7 days post-granisetron injection administration. 40 mcg/kg (N=1268) Comparator Metoclopramide/dexamethasone and phenothiazines/dexamethasone. (N=422) Headache 14% 6% Asthenia 5% 6% Somnolence 4% 15% Diarrhea 4% 6% Constipation 3% 3% In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to granisetron, except for headache, which was clearly more frequent than in comparison groups. Radiation-Induced Nausea and Vomiting In controlled clinical trials, the adverse events reported by patients receiving granisetron tablets and concurrent radiation were similar to those reported by patients receiving granisetron tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population. Postmarketing Experience QT prolongation has been reported with granisetron (see PRECAUTIONS and Drug Interactions ) .
adverse reactions table
<table ID="_RefID0EOSAE" width="100%"><caption>Table 4: Principal Adverse Events in Clinical Trials</caption><col width="19%"/><col width="21%"/><col width="21%"/><col width="21%"/><col width="18%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"/><td align="center" colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Percent of Patients with Event</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">Granisetron Hydrochloride Tablets</content><footnote ID="_Refid-1de48459-0d8a-426e-bb23-baa5643a0">Adverse events were recorded for 7 days when granisetron tablets were give on a single day and for up to 28 days when granisetron tablets were administered for 7 or 14 days.</footnote><content styleCode="bold"> 1 mg twice a day </content> <content styleCode="bold">(N=978)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">Granisetron Hydrochloride Tablets</content><footnoteRef IDREF="_Refid-1de48459-0d8a-426e-bb23-baa5643a0"/><content styleCode="bold"> 2 mg once a day (N=1450)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">Comparator</content><footnote ID="_Refid-1e90e264-4ded-41d8-ad6b-fc520b04b">Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.</footnote><content styleCode="bold"> (N=599)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">Placebo (N=185)</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>Headache<footnote ID="_Refid-a17c4eb0-d06a-4996-b9d9-6313daba9">Usually mild to moderate in severity.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>21%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>20%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>13%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>12%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>18%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>14%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>16%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>8%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>Asthenia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>14%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>18%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>10%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>4%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>Diarrhea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>8%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>9%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>10%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>4%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>Abdominal Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>6%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>4%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>6%</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>Dyspepsia</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>4%</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>6%</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>5%</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>4%</paragraph></td></tr></tbody></table>