Reported Reactions

Drugs › Substance P/Neurokinin-1 receptor antagonist

Brand name · Aprepitant

Emend: adverse event reports filed with FDA

5,750 reports list it as a suspect or interacting product, 2004–2026. Class: Substance P/Neurokinin-1 receptor antagonist. Also reported as Emend /01627301/, Emend For Injection.

5,750
reports as suspect product
0% of all reports · about 256 a year
161
reports, 12 months to June 2026
433 in the 12 months before
77.5%
marked serious by the reporter
83.3% across the class
17.3%
record death among outcomes, as reported
992 reports · not verified by FDA

5,750 adverse event reports received by FDA list the brand name Emend (aprepitant) as a suspect or interacting product, from January 2004 to June 2026. A further 6,483 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 161 reports listed it, down 63% from 433 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 256 reports a year and 0% of the 20,646,523 reports in the database, and 65.2% of the reports for the substance P/Neurokinin-1 receptor antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded dyspnoea (12.3%), pyrexia (10.9%) and nausea (10.3%). A report can list several reactions, so shares add to more than 100%; 856 different terms appear across these reports. Dyspnoea is recorded in 12.3% of these reports, a smaller share than in the median substance P/Neurokinin-1 receptor antagonist drug (22.3%).

77.5% of the reports are marked serious by the reporter (83.3% across the class); 17.3% record death among the outcomes and 45.3% record hospitalisation, as reported. 34.4% of the reports came from physicians, and the largest patient age group is 45 to 64 (31.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

03059Jul 2021: 21Aug 2021: 25Sep 2021: 6Oct 2021: 8Nov 2021: 22Dec 2021: 332022Jan 2022: 18Feb 2022: 17Mar 2022: 7Apr 2022: 24May 2022: 19Jun 2022: 15Jul 2022: 13Aug 2022: 10Sep 2022: 7Oct 2022: 7Nov 2022: 9Dec 2022: 152023Jan 2023: 21Feb 2023: 13Mar 2023: 14Apr 2023: 23May 2023: 18Jun 2023: 8Jul 2023: 24Aug 2023: 26Sep 2023: 29Oct 2023: 18Nov 2023: 12Dec 2023: 212024Jan 2024: 22Feb 2024: 32Mar 2024: 27Apr 2024: 46May 2024: 25Jun 2024: 36Jul 2024: 58Aug 2024: 54Sep 2024: 32Oct 2024: 35Nov 2024: 59Dec 2024: 552025Jan 2025: 20Feb 2025: 12Mar 2025: 53Apr 2025: 11May 2025: 10Jun 2025: 34Jul 2025: 19Aug 2025: 15Sep 2025: 21Oct 2025: 21Nov 2025: 12Dec 2025: 122026Jan 2026: 11Feb 2026: 18Mar 2026: 11Apr 2026: 5May 2026: 11Jun 2026: 5

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

03005992004: 7220042005: 752006: 542007: 6120072008: 492009: 522010: 12020102011: 1352012: 2332013: 31520132014: 4082015: 4492016: 56920162017: 5992018: 3902019: 47620192020: 3082021: 2152022: 16120222023: 2272024: 4812025: 24020252026: 61

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Emend reports recording the termmedian drug in substance p/neurokinin-1 receptor antagonist

  1. Dyspnoeashortness of breath12.3%707
  2. Pyrexiafever10.9%624
  3. Nauseafeeling sick10.3%594
  4. Hypersensitivityan allergic-type reaction9.4%542
  5. Rashskin rash8.6%496
  6. Vomitingbeing sick8.2%474
  7. Fatiguetiredness8.2%470
  8. Pruritusitching7.7%443
  9. Diarrhoealoose or frequent stools7.5%434
  10. Infusion related reactiona reaction during or soon after an infusion7%404
  11. Hepatic enzyme increasedraised liver enzymes6.8%393
  12. Confusional stateconfusion6.8%392
  13. Stomatitissore mouth6.6%379
  14. Systemic lupus erythematosuslupus, an autoimmune disease6.5%372
  15. Infectionan infection, type not specified6.4%369
  16. Impaired healingslow healing6.4%367
  17. Alopeciahair loss6.3%365
  18. Weight increasedweight gain6.2%359
  19. Off label useused for a purpose or in a way not on the label6.2%355
  20. Abdominal discomfortstomach discomfort6%345
  21. Swellingswelling5.9%342
  22. Sinusitissinus infection5.9%339
  23. Malaisegeneral feeling of being unwell5.9%338
  24. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease5.9%338

Top 30 of 856 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the substance p/neurokinin-1 receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death17.3%992
Life-threatening15.4%883
Hospitalisation (initial or prolonged)45.3%2,604
Disability12.1%697
Congenital anomaly2.7%156
Other serious47.1%2,709
Not serious22.5%1,295

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,823 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.3%16
2 to 110.6%36
12 to 171.5%88
18 to 4416.9%974
45 to 6431.7%1,821
65 to 7416.3%938
75 and over5.8%331
Age not given26.9%1,546

Patient sex

Female56.7%3,259
Male32.6%1,874
Not given10.7%617

Who reported

Physician34.4%1,980
Pharmacist13.5%779
Other health professional31.3%1,797
Lawyer0.1%4
Consumer or non-health professional19.7%1,133
Not given1%57

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Prophylaxis of nausea and vomiting1,73830.2%
Nausea3686.4%
Premedication3375.9%
Vomiting1492.6%
Prophylaxis1081.9%
Antiemetic supportive care1041.8%

The indication field is filled in by the reporter and is often blank; shares are of all 5,750 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Emend reports
Ondansetron74312.9%
Prednisone68812%
Acetaminophen64111.1%
Dexamethasone61910.8%
Folic acid60310.5%
Desoximetasone5459.5%
Methotrexate5439.4%
Rituximab5349.3%
Cisplatin5299.2%
Sulfasalazine5289.2%

Other products listed in reports where Emend is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasureEmendSubstance P/Neurokinin-1 receptor antagonistAll reports
Reports as suspect product5,7508,82320,646,523
Share of that pool—65.2%0%
Reports, latest 12 months161—1,332,454
Marked serious77.5%83.3%57.4%
Death recorded among outcomes, per 1,000 reports17321991
Hospitalisation recorded, per 1,000 reports453519213
Consumer-filed share19.7%15.4%45.8%
Top term, share of reportsDyspnoea 12.3%median 22.3%2.7%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the substance p/neurokinin-1 receptor antagonist class

DrugName typeReportsLatest 12 monthsMarked serious
Aprepitantgeneric2,48632896.8%
Fosaprepitantgeneric58714682.6%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about Emend reports

How many adverse event reports has FDA received for Emend?

5,750 reports list Emend as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 161 of them arrived in the latest 12 months. Another 6,483 list it only as a concomitant medication.

What reactions are recorded in Emend reports?

dyspnoea (12.3%), pyrexia (10.9%), nausea (10.3%), hypersensitivity (9.4%) and rash (8.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Emend was responsible.

How serious are the reports?

77.5% are marked serious by the reporter. Among the outcomes recorded, 17.3% of reports include death and 45.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

physician (34.4%), other health professional (31.3%) and consumer or non-health professional (19.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Emend rising?

161 reports in the 12 months to June 2026, down 63% from 433 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Emend was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Emend?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Emend as a suspect or interacting product; reports listing it only as a concomitant medication (6,483) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.