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Emend Capsules

Emend Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Emend (aprepitant) is used together with other medications to prevent nausea and vomiting that may be caused by surgery or cancer chemotherapy. It is given ahead of time and will not treat nausea or vomiting you already have. It is an antiemetic. Common side effects include tiredness and hiccups.

The recommended dose of Emend is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. Emend may interact with birth control pills, diltiazem, tolbutamide, blood thinners, midazolam or similar medicines, antidepressants, antibiotics, antifungals, cancer medicines, HIV medicines, seizure medications, steroids. Tell your doctor all medications you use. During pregnancy, Emend should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Emend (aprepitant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Emend in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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:

  • feeling like you might pass out;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Less serious side effects may include:

  • nausea, vomiting, heartburn, stomach pain;
  • diarrhea or constipation;
  • loss of appetite;
  • hiccups;
  • hair loss;
  • headache;
  • dizziness;
  • tired feeling;
  • mild skin rash;
  • ringing in your ears; 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.

Read the entire detailed patient monograph for Emend (Aprepitant Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Emend Overview - Patient Information: Side Effects

SIDE EFFECTS: Tiredness and hiccups may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Emend (Aprepitant Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Emend FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The overall safety of aprepitant was evaluated in approximately 5300 individuals.

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.

Clinical Trials Experience

Chemotherapy Induced Nausea and Vomiting

Highly Emetogenic Chemotherapy

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. EMEND was given in combination with ondansetron and dexamethasone.

In Cycle 1, clinical adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 68% of patients treated with standard therapy. Table 1 shows the percent of patients with clinical adverse experiences reported at an incidence ≥ 3%.

Table 1: Percent of Patients Receiving Highly Emetogenic Chemotherapy with Clinical Adverse Experiences (Incidence ≥ 3%) - Cycle 1

  Aprepitant Regimen
(N = 544)
Standard Therapy
(N = 550)
Body as a Whole/ Site Unspecified
  Asthenia/Fatigue 17.8 11.8
  Dizziness 6.6 4.4
  Dehydration 5.9 5.1
  Abdominal Pain 4.6 3.3
  Fever 2.9 3.5
  Mucous Membrane Disorder 2.6 3.1
Digestive System
  Nausea 1 2.7 11.8
  Constipation 10.3 12.2
  Diarrhea 10.3 7.5
  Vomiting 7.5 7.6
  Heartburn 5.3 4.9
  Gastritis 4.2 3.1
  Epigastric Discomfort 4.0 3.1
Eyes, Ears, Nose, and Throat
  Tinnitus 3.7 3.8
Hemic and Lymphatic System
  Neutropenia 3.1 2.9
Metabolism and Nutrition
  Anorexia 10.1 9.5
Nervous System 
  Headache 8.5 8.7
  Insomnia 2.9 3.1
Respiratory System
  Hiccups 10.8 5.6

In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies.

Moderately Emetogenic Chemotherapy

During Cycle 1 of 2 moderately emetogenic chemotherapy studies, 868 patients were treated with the aprepitant regimen and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In the combined analysis of Cycle 1 data for these 2 studies, adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy.

In the combined analysis of Cycle 1 data for these 2 studies, the adverse experience profile in both moderately emetogenic chemotherapy studies was generally comparable to the highly emetogenic chemotherapy studies. Table 2 shows the percent of patients with clinical adverse experiences reported at an incidence ≥ 3%.

Table 2: Percent of Patients Receiving Moderately Emetogenic Chemotherapy with Clinical Adverse Experiences (Incidence ≥ 3%) - Cycle 1

  Aprepitant Regimen
(N = 868)
Standard Therapy
(N = 846)
Blood and Lymphatic System Disorders
  Neutropenia 5.8 5.6
Metabolism and Nutrition Disorders
  Anorexia 6.2 7.2
Psychiatric Disorders
  Insomnia 2.6 3.7
Nervous System Disorders
  Headache 13.2 14.3
  Dizziness 2.8 3.4
Gastrointestinal Disorders
  Constipation 10.3 15.5
  Diarrhea 7.6 8.7
  Dyspepsia 5.8 3.8
  Nausea 5.8 5.1
  Stomatitis 3.1 2.7
Skin and Subcutaneous Tissue Disorders
  Alopecia 12.4 11.9
General Disorders and General Administration Site Conditions
  Fatigue 15.4 15.6
  Asthenia 4.7 4.6

In a combined analysis of these two studies, isolated cases of serious adverse experiences were similar in the two treatment groups.

Highly and Moderately Emetogenic Chemotherapy

The following additional clinical adverse experiences (incidence > 0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen in either HEC or MEC studies:

Infections and infestations: candidiasis, herpes simplex, lower respiratory infection, oral candidiasis, pharyngitis, septic shock, upper respiratory infection, urinary tract infection.

Neoplasms benign, malignant and unspecified (including cysts and polyps): malignant neoplasm, nonsmall cell lung carcinoma.

Blood and lymphatic system disorders: anemia, febrile neutropenia, thrombocytopenia.

Metabolism and nutrition disorders: appetite decreased, diabetes mellitus, hypokalemia.

Psychiatric disorders: anxiety disorder, confusion, depression.

Nervous system: peripheral neuropathy, sensory neuropathy, taste disturbance, tremor.

Eye disorders: conjunctivitis.

Cardiac disorders: myocardial infarction, palpitations, tachycardia.

Vascular disorders: deep venous thrombosis, flushing, hot flush, hypertension, hypotension.

Respiratory, thoracic and mediastinal disorders: cough, dyspnea, nasal secretion, pharyngolaryngeal pain, pneumonitis, pulmonary embolism, respiratory insufficiency, vocal disturbance.

Gastrointestinal disorders: abdominal pain upper, acid reflux, deglutition disorder, dry mouth, dysgeusia, dysphagia, eructation, flatulence, obstipation, salivation increased.

Skin and subcutaneous tissue disorders: acne, diaphoresis, pruritus, rash.

Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscular weakness, musculoskeletal pain, myalgia.

Renal and urinary disorders: dysuria, renal insufficiency.

Reproductive system and breast disorders: pelvic pain.

General disorders and administrative site conditions: edema, malaise, pain, rigors.

Investigations: weight loss.

Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy in another CINV study.

Laboratory Adverse Experiences

Table 3 shows the percent of patients with laboratory adverse experiences reported at an incidence ≥ 3% in patients receiving highly emetogenic chemotherapy.

Table 3: Percent of Patients Receiving Highly Emetogenic Chemotherapy with Laboratory Adverse Experiences (Incidence ≥ 3%) - Cycle 1

  Aprepitant Regimen
(N = 544)
Standard Therapy
(N = 550)
Proteinuria 6.8 5.3
ALT Increased 6.0 4.3
Blood Urea Nitrogen Increased 4.7 3.5
Serum Creatinine Increased 3.7 4.3
AST Increased 3.0 1.3

The following additional laboratory adverse experiences (incidence > 0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen: alkaline phosphatase increased, hyperglycemia, hyponatremia, leukocytes increased, erythrocyturia, leukocyturia.

The adverse experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.

Postoperative Nausea and Vomiting

In well-controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron IV.

Clinical adverse experiences were reported in approximately 60% of patients treated with 40 mg aprepitant compared with approximately 64% of patients treated with 4 mg ondansetron IV. Table 4 shows the percent of patients with clinical adverse experiences reported at an incidence ≥ 3% of the combined studies.

Table 4 : Percent of Patients Receiving General Anesthesia with Clinical Adverse Experiences (Incidence ≥ 3%)

  Aprepitant 40 mg
(N = 564)
Ondansetron
(N = 538)
Infections and Infestations
Urinary Tract Infection 2.3 3.2
Blood and Lymphatic System Disorders
Anemia 3.0 4.3
Psychiatric Disorders
Insomnia 2.1 3.3
Nervous System
Disorders Headache 5.0 6.5
Cardiac Disorders
Bradycardia 4.4 3.9
Vascular Disorders
Hypotension 5.7 4.6
Hypertension 2.1 3.2
Gastrointestinal Disorders
Nausea 8.5 8.6
Constipation 8.5 7.6
Flatulence 4.1 5.8
Vomiting 2.5 3.9
Skin and Subcutaneous Tissue Disorders
Pruritus 7.6 8.4
General Disorders and General Administration Site
Conditions Pyrexia 5.9 10.6

The following additional clinical adverse experiences (incidence > 0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant:

Infections and infestations: postoperative infection

Metabolism and nutrition disorders: hypokalemia, hypovolemia.

Nervous system disorders: dizziness, hypoesthesia, syncope.

Vascular disorders: hematoma

Respiratory, thoracic and mediastinal disorders: dyspnea, hypoxia, respiratory depression.

Gastrointestinal disorders: abdominal pain, abdominal pain upper, dry mouth, dyspepsia.

Skin and subcutaneous tissue disorders: urticaria

General disorders and administrative site conditions: hypothermia, pain.

Investigations: blood pressure decreased

Injury, poisoning and procedural complications: operative hemorrhage, wound dehiscence.

Other adverse experiences (incidence ≤ 0.5%) reported in patients treated with aprepitant 40 mg for postoperative nausea and vomiting included:

Nervous system disorders: dysarthria, sensory disturbance.

Eye disorders: miosis, visual acuity reduced.

Respiratory, thoracic and mediastinal disorders: wheezing

Gastrointestinal disorders: bowel sounds abnormal, stomach discomfort.

There were no serious adverse drug-related experiences reported in the postoperative nausea and vomiting clinical studies in patients taking 40 mg aprepitant.

Laboratory Adverse Experiences

One laboratory adverse experience, hemoglobin decreased (40 mg aprepitant 3.8%, ondansetron 4.2%), was reported at an incidence ≥ 3% in a patient receiving general anesthesia.

The following additional laboratory adverse experiences (incidence > 0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant 40 mg: blood albumin decreased, blood bilirubin increased, blood glucose increased, blood potassium decreased, glucose urine present.

The adverse experience of ALT increased occurred with similar incidence in patients treated with aprepitant 40 mg (1.1%) as in patients treated with ondansetron 4 mg (1.0%).

Other Studies

In addition, two serious adverse experiences 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 sub-ileus.

Angioedema and urticaria were reported as serious adverse experiences in a patient receiving aprepitant in a non-CINV/non-PONV study.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not 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.

Read the entire FDA prescribing information for Emend (Aprepitant Capsules) »

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Emend Capsules - User Reviews

Emend Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Emend Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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