What are the possible side effects of Emetril?
Get emergency medical help if you have any of these signs of an allergic reaction to Emetril: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
-
fast or pounding heartbeats;
-
fever, body aches, flu symptoms; or
-
easy bruising or bleeding; unusual weakness.
Less serious Emetril side effects may include:
-
headache;
-
stomach pain or upset, loss of appetite;
-
diarrhea or constipation;
-
dizziness; or
-
sleep problems (insomnia);
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Emetril in details
QT prolongation has been reported with Emetril hydrochloride.
Chemotherapy-Induced Nausea and Vomiting
Over 3700 patients have received Emetril hydrochloride tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens. In patients receiving Emetril hydrochloride tablets 1 mg twice a day 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 inTable 4.
| Percent of Patients With Event | ||||
| Emetril Hydrochloride1 Tablets 1 mg twice a day (n=978) | Emetril Hydrochloride1 Tablets 2 mg once a day (n=1450) | Comparator2 (n=599) | Placebo (n=185) | |
| Headache | 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% |
1 Adverse events were recorded for 7 days when Emetril hydrochloride tablets were given on a single day and for up to 28 days when Emetril hydrochloride tablets were administered for 7 or 14 days.
2 Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.
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 Emetril hydrochloride 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 Emetril hydrochloride tablets.
Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (e.g., 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 Emetril hydrochloride in clinical trials.
Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥3%) in patients receiving Emetril hydrochloride injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24 hour period following Emetril hydrochloride injection administration.
| Percent of Patients with Event | ||
| Emetril Hydrochloride Injection1 40 mcg/kg (n=1268) | Comparator2 (n=422) | |
| Headache | 14% | 6% |
| Asthenia | 5% | 6% |
| Somnolence | 4% | 15% |
| Diarrhea | 4% | 6% |
| Constipation | 3% | 3% |
1 Adverse events were generally recorded over 7 days post-Emetril hydrochloride injection administration.
2 Metoclopramide/dexamethasone and phenothiazines/dexamethasone.
In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to Emetril hydrochloride, 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 Emetril hydrochloride tablets and concurrent radiation were similar to those reported by patients receiving Emetril hydrochloride 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 Emetril hydrochloride.
What is the most important information I should know about Emetril?
- Emetril tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Emetril tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Emetril tablets. Your risk may be greater if you take Emetril tablets with certain other medicines (eg, certain medicines used to treat depression, pain, migraines). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Emetril tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emetril tablets while you are pregnant. It is not known if Emetril tablets is found in breast milk. If you are or will be breast-feeding while you use Emetril tablets, check with your doctor. Discuss any possible risks to your baby.
Emetril contraindications
You should not use this medication if you are allergic to Emetril or to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).
Before taking Emetril, tell your doctor if you have liver disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.
Emetril is usually started up to 1 hour before chemotherapy. Tell your doctor if you forget to take the medication within the specified amount of time before your procedure.
References
- DailyMed. "GRANISETRON: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]nonan-7-yl)indazole-3-carboxamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- NCIt. "Granisetron: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Emetril are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Emetril. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
