Reported Reactions

Drugs

Product name as reported

Docetaxel Hospira: adverse event reports filed with FDA

1,138 reports list it as a suspect or interacting product, 2013–2021.

1,138
reports as suspect product
0% of all reports · about 85 a year
0
reports, 12 months to June 2026
0 in the 12 months before
21.3%
marked serious by the reporter
57.4% across all reports
2.8%
record death among outcomes, as reported
32 reports · not verified by FDA

Between February 2013 and September 2021, 1,138 adverse event reports received by FDA list the product name "Docetaxel Hospira" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (6) are left out of every figure here.

In the 12 months to June 2026, 0 reports listed it, and none 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 85 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded alopecia (81%), injury (43.8%) and emotional distress (41.8%). A report can list several reactions, so shares add to more than 100%; 129 different terms appear across these reports. Alopecia is recorded in 81% of these reports, against 0.9% of all reports in the database.

21.3% of the reports are marked serious by the reporter; 2.8% record death among the outcomes and 11.9% record hospitalisation, as reported. 45.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (14.3%). 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

047Jul 2021: 1Aug 2021: 0Sep 2021: 7Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0

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

02494982013: 320132014: 620142015: 2720152016: 3720162017: 8920172018: 12420182019: 49820192020: 30120202021: 532021

Reactions recorded in the reports

share of Docetaxel Hospira reports recording the termall reports in the database

  1. Alopeciahair loss81%922
  2. Injurya physical injury43.8%498
  3. Emotional distressemotional distress41.8%476
  4. Anxietyanxiety34.2%389
  5. Discomfortdiscomfort33.1%377
  6. Anhedonia32.2%367
  7. Painpain, site not specified32.2%367
  8. Deformity26.1%297
  9. Madarosis25.7%292
  10. Diarrhoealoose or frequent stools3.7%42
  11. Alopecia areata2.4%27
  12. Nauseafeeling sick2.4%27
  13. Septic shockshock arising from infection1.6%18
  14. Arthralgiajoint pain1.5%17
  15. Vomitingbeing sick1.5%17
  16. Erythemaskin redness1.3%15
  17. Acute kidney injurysudden loss of kidney function1.1%13
  18. Abdominal painstomach or belly pain1.1%12
  19. Dyspnoeashortness of breath1.1%12
  20. Fatiguetiredness1.1%12
  21. Myalgiamuscle pain1.1%12
  22. Neutropenialow neutrophils, a type of white blood cell1%11
  23. Febrile neutropeniafever with low white blood cells0.9%10
  24. Off label useused for a purpose or in a way not on the label0.9%10
  25. Back painback pain0.8%9

Top 30 of 129 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 share of all reports in the database; 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

Death2.8%32
Life-threatening1.8%20
Hospitalisation (initial or prolonged)11.9%135
Disability4.3%49
Congenital anomaly0%0
Other serious7.6%86
Not serious78.7%896

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 20,646,523 reports. 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%0
2 to 110%0
12 to 170%0
18 to 441.9%22
45 to 6414.3%163
65 to 743.9%44
75 and over1.9%22
Age not given77.9%887

Patient sex

Female24.4%278
Male6.8%77
Not given68.8%783

Who reported

Physician5.1%58
Pharmacist2.1%24
Other health professional9.3%106
Lawyer38.2%435
Consumer or non-health professional45.3%515
Not given0%0

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Breast cancer12911.3%
Breast cancer female322.8%
Invasive ductal breast carcinoma232%
Prostate cancer141.2%
Lung neoplasm malignant70.6%
Chemotherapy50.4%

The indication field is filled in by the reporter and is often blank; shares are of all 1,138 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Docetaxel Hospira reports
Docetaxel88577.8%
Taxotere87877.2%
Docetaxel Accord80070.3%
Herceptin564.9%
Cytoxan221.9%
Perjeta221.9%
Neulasta211.8%
Ondansetron211.8%
Carboplatin181.6%

Other products listed in reports where Docetaxel Hospira 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

MeasureDocetaxel HospiraAll reports
Reports as suspect product1,13820,646,523
Share of that pool—0%
Reports, latest 12 months01,332,454
Marked serious21.3%57.4%
Death recorded among outcomes, per 1,000 reports2891
Hospitalisation recorded, per 1,000 reports119213
Consumer-filed share45.3%45.8%
Top term, share of reportsAlopecia 81%0.9%

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."

Questions about Docetaxel Hospira reports

How many adverse event reports has FDA received for Docetaxel Hospira?

1,138 reports list Docetaxel Hospira as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 6 list it only as a concomitant medication.

What reactions are recorded in Docetaxel Hospira reports?

alopecia (81%), injury (43.8%), emotional distress (41.8%), anxiety (34.2%) and discomfort (33.1%). 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 Docetaxel Hospira was responsible.

How serious are the reports?

21.3% are marked serious by the reporter. Among the outcomes recorded, 2.8% of reports include death and 11.9% 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?

consumer or non-health professional (45.3%), lawyer (38.2%) and other health professional (9.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Docetaxel Hospira rising?

0 reports in the 12 months to June 2026, and none 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 Docetaxel Hospira 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 Docetaxel Hospira?

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 Docetaxel Hospira as a suspect or interacting product; reports listing it only as a concomitant medication (6) 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.