Reported Reactions

Drugs › Epidermal growth factor receptor antagonist

Generic name

Panitumumab: adverse event reports filed with FDA

5,664 reports list it as a suspect or interacting product, 2005–2026. Class: Epidermal growth factor receptor antagonist. Also reported as Panitumumab Solution For Injection.

5,664
reports as suspect product
0% of all reports · about 274 a year
220
reports, 12 months to June 2026
233 in the 12 months before
98%
marked serious by the reporter
85.5% across the class
20.9%
record death among outcomes, as reported
1,182 reports · not verified by FDA

5,664 adverse event reports received by FDA list panitumumab, a generic name as a suspect or interacting product, from November 2005 to June 2026. A further 426 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, 220 reports listed it, close to the 233 of 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 274 reports a year and 0% of the 20,646,523 reports in the database, and 12.9% of the reports for the epidermal growth factor 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 diarrhoea (14.3%), neutropenia (8.8%) and dermatitis acneiform (8.6%). A report can list several reactions, so shares add to more than 100%; 749 different terms appear across these reports. Diarrhoea is recorded in 14.3% of these reports, a larger share than in the median epidermal growth factor receptor antagonist drug (8.6%).

98% of the reports are marked serious by the reporter (85.5% across the class); 20.9% record death among the outcomes and 46% record hospitalisation, as reported. 58.4% of the reports came from physicians, and the largest patient age group is 45 to 64 (29.4%). 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

02447Jul 2021: 47Aug 2021: 32Sep 2021: 28Oct 2021: 31Nov 2021: 31Dec 2021: 362022Jan 2022: 34Feb 2022: 26Mar 2022: 31Apr 2022: 23May 2022: 31Jun 2022: 37Jul 2022: 22Aug 2022: 30Sep 2022: 22Oct 2022: 27Nov 2022: 37Dec 2022: 372023Jan 2023: 41Feb 2023: 34Mar 2023: 27Apr 2023: 22May 2023: 34Jun 2023: 39Jul 2023: 26Aug 2023: 24Sep 2023: 42Oct 2023: 46Nov 2023: 27Dec 2023: 252024Jan 2024: 13Feb 2024: 26Mar 2024: 15Apr 2024: 16May 2024: 21Jun 2024: 21Jul 2024: 18Aug 2024: 10Sep 2024: 8Oct 2024: 19Nov 2024: 28Dec 2024: 252025Jan 2025: 20Feb 2025: 36Mar 2025: 21Apr 2025: 23May 2025: 15Jun 2025: 10Jul 2025: 36Aug 2025: 17Sep 2025: 23Oct 2025: 19Nov 2025: 15Dec 2025: 102026Jan 2026: 15Feb 2026: 13Mar 2026: 22Apr 2026: 15May 2026: 22Jun 2026: 13

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

02685362005: 320052006: 242007: 1602008: 21920082009: 1802010: 2032011: 44520112012: 2752013: 1872014: 19220142015: 1782016: 2212017: 32820172018: 5362019: 4632020: 38620202021: 3552022: 3572023: 38720232024: 2202025: 2452026: 1002026

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Panitumumab reports recording the termmedian drug in epidermal growth factor receptor antagonist

  1. Diarrhoealoose or frequent stools14.3%808
  2. Neutropenialow neutrophils, a type of white blood cell8.8%501
  3. Rashskin rash7.5%426
  4. Deaththe patient died; cause not stated by this term7.1%400
  5. Nauseafeeling sick6.9%390
  6. Hypomagnesaemialow blood magnesium6%339
  7. Stomatitissore mouth5.9%335
  8. Colorectal cancer metastatic5.8%327
  9. Vomitingbeing sick5.3%298
  10. Decreased appetitereduced appetite5.2%297
  11. Fatiguetiredness5.2%297
  12. Thrombocytopenialow platelets5.2%295
  13. Paronychia5.2%294
  14. Anaemialow red blood cells5%286
  15. Neuropathy peripheralnerve damage in hands or feet4.9%280
  16. Off label useused for a purpose or in a way not on the label4.4%251
  17. Disease progressionthe disease advanced4.4%249
  18. Febrile neutropeniafever with low white blood cells3.8%214
  19. Astheniaweakness or lack of energy3.7%212
  20. Pyrexiafever3.7%212
  21. Dehydrationdehydration3.7%208
  22. Dry skindry skin3.5%196
  23. Pulmonary embolisma blood clot in the lung2.7%152
  24. Interstitial lung diseasescarring or inflammation of lung tissue2.6%145

Top 30 of 749 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 4 drugs in the epidermal growth factor 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

Death20.9%1,182
Life-threatening8.4%476
Hospitalisation (initial or prolonged)46%2,605
Disability1.1%65
Congenital anomaly0.1%6
Other serious60.2%3,412
Not serious2%115

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 43,907 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%0
2 to 110.1%5
12 to 170.2%11
18 to 445.3%303
45 to 6429.4%1,667
65 to 7423.6%1,336
75 and over10%564
Age not given31.4%1,778

Patient sex

Female30.5%1,728
Male51.3%2,903
Not given18.2%1,033

Who reported

Physician58.4%3,309
Pharmacist2.6%147
Other health professional36.6%2,073
Lawyer0%0
Consumer or non-health professional1.8%101
Not given0.6%34

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 15.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Colorectal cancer metastatic1,47026%
Colorectal cancer1,20721.3%
Colon cancer3446.1%
Adenocarcinoma of colon2444.3%
Squamous cell carcinoma1412.5%
Colon cancer metastatic1182.1%

The indication field is filled in by the reporter and is often blank; shares are of all 5,664 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Panitumumab reports
Fluorouracil2,66247%
Oxaliplatin2,43443%
Irinotecan1,29522.9%
Folinic Acid81014.3%
Leucovorin74713.2%
Bevacizumab72112.7%
Leucovorin calcium5289.3%
Capecitabine5028.9%
Irinotecan hcl3416%
Cetuximab3245.7%

Other products listed in reports where Panitumumab 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

MeasurePanitumumabEpidermal growth factor receptor antagonistAll reports
Reports as suspect product5,66443,90720,646,523
Share of that pool—12.9%0%
Reports, latest 12 months220—1,332,454
Marked serious98%85.5%57.4%
Death recorded among outcomes, per 1,000 reports20914291
Hospitalisation recorded, per 1,000 reports460387213
Consumer-filed share1.8%33.6%45.8%
Top term, share of reportsDiarrhoea 14.3%median 8.6%3.1%

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 epidermal growth factor receptor antagonist class

DrugName typeReportsLatest 12 monthsMarked serious
Erbituxbrand18,12183177%
Cetuximabgeneric10,86651297.5%
Vectibixbrand9,2561,07980.4%

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 Panitumumab reports

How many adverse event reports has FDA received for Panitumumab?

5,664 reports list Panitumumab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 220 of them arrived in the latest 12 months. Another 426 list it only as a concomitant medication.

What reactions are recorded in Panitumumab reports?

diarrhoea (14.3%), neutropenia (8.8%), dermatitis acneiform (8.6%), rash (7.5%) and death (7.1%). 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 Panitumumab was responsible.

How serious are the reports?

98% are marked serious by the reporter. Among the outcomes recorded, 20.9% of reports include death and 46% 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 (58.4%), other health professional (36.6%) and pharmacist (2.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Panitumumab rising?

220 reports in the 12 months to June 2026, close to the 233 of 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 Panitumumab 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 Panitumumab?

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 Panitumumab as a suspect or interacting product; reports listing it only as a concomitant medication (426) 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.