Emend Side Effects
Generic Name: aprepitant
Please note - some side effects for Emend may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Emend - for the Consumer
Emend
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Emend:
Seek medical attention right away if any of these SEVERE side effects occur when using Emend:Constipation; diarrhea; dizziness; hair loss; headache; heartburn; hiccups; loss of appetite; nausea; tiredness; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling of your arms, hands, legs, or feet; burning or pain during urination; chest, jaw, or left arm pain; confusion; difficult or decreased urination; fainting; fast, slow, or irregular heartbeat; flushing; mental or mood changes (eg, depression); pain, redness, or swelling in the legs; red, swollen, blistered, or peeling skin; severe or persistent dizziness, headache, heartburn, or stomach pain; severe rash with fever, mouth sores, or red and irritated eyes; signs of infection (eg, fever, chills, persistent sore throat); soreness of the mouth or tongue; shortness of breath; strong urge to urinate.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Emend for Injection Pimozide
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Emend for Injection Pimozide:
Seek medical attention right away if any of these SEVERE side effects occur when using Emend for Injection Pimozide:Constipation; diarrhea; dizziness; headache; hiccups; loss of appetite; nausea; pain or hardening at the injection site; tiredness; upset stomach; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever; shortness of breath; sore throat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopEmend Side Effects - for the Professional
Emend
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Since Emend for Injection is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with Emend for Injection.
The overall safety of fosaprepitant was evaluated in approximately 1100 individuals and the overall safety of aprepitant was evaluated in approximately 6500 individuals.
Oral Aprepitant
Highly Emetogenic Chemotherapy (HEC)
In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. Oral aprepitant was given in combination with ondansetron and dexamethasone.
In Cycle 1, adverse reactions were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy. Treatment was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
The most common adverse reactions reported in patients treated with the aprepitant regimen with an incidence ≥1% and greater than standard therapy are listed in Table 5.
|
Aprepitant Regimen (N=544) |
Standard Therapy (N=550) |
|
| Respiratory System | ||
| hiccups | 4.6 | 2.9 |
| Body as a Whole/Site Unspecified | ||
| asthenia/fatigue | 2.9 | 1.6 |
| Investigations | ||
| ALT increased | 2.8 | 1.5 |
| AST increased | 1.1 | 0.9 |
| Digestive System | ||
| constipation | 2.2 | 2.0 |
| dyspepsia | 1.5 | 0.7 |
| diarrhea | 1.1 | 0.9 |
| Nervous System | ||
| headache | 2.2 | 1.8 |
| Metabolism and Nutrition | ||
| anorexia | 2.0 | 0.5 |
A listing of adverse reactions in the aprepitant regimen (incidence <1%) that occurred at a greater incidence than standard therapy are presented in the Less Common Adverse Reactions subsection below.
In an additional active-controlled clinical study in 1169 patients receiving aprepitant and highly emetogenic chemotherapy, the adverse experience profile was generally similar to that seen in the other HEC studies with aprepitant.
Moderately Emetogenic Chemotherapy (MEC)
In 2 well-controlled clinical trials in patients receiving moderately emetogenic cancer chemotherapy, 868 patients were treated with the aprepitant during Cycle 1 of chemotherapy and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In both studies, oral aprepitant was given in combination with ondansetron and dexamethasone (aprepitant regimen).
In the combined analysis of Cycle 1 data for these 2 studies, adverse reactions were reported in approximately 14% of patients treated with the aprepitant regimen compared with approximately 15% of patients treated with standard therapy. Treatment was discontinued due to adverse reactions in 0.7% of patients treated with the aprepitant regimen compared with 0.2% of patients treated with standard therapy.
The most common adverse reactions reported in patients treated with the aprepitant regimen with an incidence ≥1% and greater than standard therapy are listed in Table 6.
|
Aprepitant Regimen (N=868) |
Standard Therapy (N=846) |
|
| Gastrointestinal disorders | ||
| eructation | 1.0 | 0.1 |
| General disorders and administration site conditions | ||
| fatigue | 1.4 | 0.9 |
A listing of adverse reactions in the aprepitant regimen (incidence <1%) that occurred at a greater incidence than standard therapy are presented in the Less Common Adverse Reactions subsection below.
Less Common Adverse Reactions
Adverse reactions reported in either HEC or MEC studies in patients treated with the aprepitant regimen with an incidence <1% and greater than standard therapy are listed in Table 7.
| Infection and infestations | candidiasis, staphylococcal infection |
| Blood and the lymphatic system disorders | anemia, febrile neutropenia |
| Metabolism and nutrition disorders | weight gain, polydipsia |
| Psychiatric disorders | disorientation, euphoria, anxiety |
| Nervous system disorders | dizziness, dream abnormality, cognitive disorder, lethargy, somnolence |
| Eye disorders | conjunctivitis |
| Ear and labyrinth disorders | tinnitus |
| Cardiac disorders | bradycardia, cardiovascular disorder, palpitations |
| Vascular disorders | hot flush, flushing |
| Respiratory, thoracic and mediastinal disorders | pharyngitis, sneezing, cough, postnasal drip, throat irritation |
| Gastrointestinal disorders | nausea, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, perforating duodenal ulcer, vomiting, abdominal pain, dry mouth, abdominal distension, faeces hard, neutropenic colitis, flatulence, stomatitis |
| Skin and subcutaneous tissue disorders | rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion |
| Musculoskeletal and connective tissue disorders | muscle cramp, myalgia, muscular weakness |
| Renal and urinary disorders | polyuria, dysuria, pollakiuria |
| General disorders and administration site condition | edema, chest discomfort, malaise, thirst, chills, gait disturbance |
| Investigations | alkaline phosphatase increased, hyperglycemia, microscopic hematuria, hyponatremia, weight decreased, neutrophil count decreased |
In another chemotherapy induced nausea and vomiting (CINV) study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving aprepitant with cancer chemotherapy.
The adverse experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were similar to that observed in Cycle 1.
Fosaprepitant
In an active-controlled clinical study in patients receiving highly emetogenic chemotherapy, safety was evaluated for 1143 patients receiving the 1-day regimen of Emend for Injection 150 mg compared to 1169 patients receiving the 3-day regimen of Emend (aprepitant). The safety profile was generally similar to that seen in prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared to those in the aprepitant group (0.5%). The reported infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.
The following additional adverse reactions occurred with fosaprepitant 150 mg and were not reported with the oral aprepitant regimen in the corresponding section above.
| General disorders and administration site conditions | infusion site erythema, infusion site pruritus, infusion site induration, infusion site pain |
| Investigations | blood pressure increased |
| Skin and subcutaneous tissue disorders | erythema |
| Vascular disorders | thrombophlebitis (predominantly, infusion-site thrombophlebitis) |
Other Studies with Postoperative Nausea and Vomiting
In well-controlled clinical studies in patients receiving general balanced anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron intravenously.
Adverse reactions were reported in approximately 4% of patients treated with 40 mg aprepitant compared with approximately 6% of patients treated with 4 mg ondansetron intravenously.
In patients treated with aprepitant, increased ALT (1.1%) was seen at a greater incidence than with ondansetron (1.0%). The following additional adverse reactions were observed in patients treated with aprepitant at an incidence <1% and greater than with ondansetron.
| Psychiatric disorders | insomnia |
| Nervous system disorders | dysarthria, hypoesthesia, sensory disturbance |
| Eye disorders | miosis, visual acuity reduced |
| Cardiac disorders | bradycardia |
| Respiratory, thoracic and mediastinal disorders | dyspnea, wheezing |
| Gastrointestinal disorders | abdominal pain upper, bowel sounds abnormal, dry mouth, nausea, stomach discomfort |
In addition, two serious adverse reactions were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of subileus.
Other Studies
Angioedema and urticaria were reported as serious adverse reactions in a patient receiving aprepitant in a non-CINV/non-PONV study.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of fosaprepitant and aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, rarely Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions.
TopSide Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic side effects including alopecia (24%) and rash have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with moderately or highly emetogenic cancer chemotherapy. Pruritus and urticaria have also been reported.
General
General side effects including asthenia/fatigue (17.8%), dizziness (3.4% to 6.6%), dehydration (5.9%), abdominal pain (4.6%), fever (2.9%), mucous membrane disorder (2.6%) have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with moderately or highly emetogenic cancer chemotherapy. Diaphoresis, edema, flushing, malaise, pelvic pain, septic shock, and upper respiratory infection have also been reported.
Nervous system
Nervous system side effects including headache (8.5% to 16.4%) and insomnia (2.9%) have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy. Peripheral neuropathy and sensory neuropathy have also been reported.
Gastrointestinal
Gastrointestinal side effects including nausea (7.1% to 12.7%), constipation (10.3% to 12.3%), diarrhea (5.5% to 10.3%), dyspepsia (8.4%), vomiting (7.5%), stomatitis (5.3%), heartburn (5.3%), gastritis (4.2%), and epigastric discomfort (4.0%) have been reported with the use of aprepitant as a part of a regimen with ondansetron and dexamethasone which was given along with moderately or highly emetogenic cancer chemotherapy. Acid reflux, deglutination, disorder, dysgeusia, dysphagia, flatulence, obstipation, increased salivation, and taste disturbance have also been reported.
Respiratory
Respiratory side effects including hiccups (10.8%) have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with moderately or highly emetogenic cancer chemotherapy. Cough, dyspnea, pneumonitis, respiratory insufficiency, lower respiratory infection, nasal secretion, pharyngitis, pharyngolaryngeal pain, and vocal disturbance have also been reported.
Other
Other side effects including anorexia (4.3% to 10.1%) and tinnitus (3.7%) have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with moderately or highly emetogenic cancer chemotherapy.
Oncologic
Oncologic side effects including malignant neoplasm and non-small cell lung carcinoma have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy.
Thyroid follicular cell adenomas and carcinomas in male rats and increased incidences of hepatocellular adenoma and thyroid follicular adenoma in female rats have been reported. The drug has also been reported to cause skin fibrosarcomas in male mice.
Hematologic
Hematologic side effects including neutropenia have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy. Anemia, febrile neutropenia, and thrombocytopenia have also been reported.
Cardiovascular
Cardiovascular side effects including deep vein thrombosis, hypertension, hypotension, myocardial infarction, pulmonary embolism, and tachycardia have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy.
Metabolic
Metabolic side effects including diabetes mellitus have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy. Decreased appetite, hypokalemia, and weight loss have also been reported.
Musculoskeletal
Musculoskeletal side effects including muscular weakness, musculoskeletal pain, and myalgia have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy.
Psychiatric
Psychiatric side effects including anxiety disorder, confusion, and depression have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy.
Genitourinary
Genitourinary side effects including dysuria and renal insufficiency have been reported with the use of aprepitant as a part of a regimen that also included ondansetron and dexamethasone which was given along with highly emetogenic cancer chemotherapy.
Hypersensitivity
Hypersensitivity side effects including anaphylactic reactions have been reported.
TopMore Emend resources
- Emend Prescribing Information (FDA)
- Emend Monograph (AHFS DI)
- Emend Advanced Consumer (Micromedex) - Includes Dosage Information
- Emend Consumer Overview
- Emend MedFacts Consumer Leaflet (Wolters Kluwer)
- Aprepitant Professional Patient Advice (Wolters Kluwer)
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