Reported Reactions

Drugs › Kinase inhibitor

Generic name

Pazopanib: adverse event reports filed with FDA

4,170 reports list it as a suspect or interacting product, 2006–2026. Class: Kinase inhibitor. Also reported as Pazopanib Tablet, Pazopanib 200mg, Pazopanib Suspension.

4,170
reports as suspect product
0% of all reports · about 209 a year
164
reports, 12 months to June 2026
242 in the 12 months before
97.5%
marked serious by the reporter
70.8% across the class
20.7%
record death among outcomes, as reported
863 reports · not verified by FDA

Between August 2006 and June 2026, 4,170 adverse event reports received by FDA list pazopanib, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (335) are left out of every figure here.

In the 12 months to June 2026, 164 reports listed it, down 32% from 242 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 209 reports a year and 0% of the 20,646,523 reports in the database, and 0.5% of the reports for the kinase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded malignant neoplasm progression (11.4%), product use in unapproved indication (7.6%) and diarrhoea (6.9%). A report can list several reactions, so shares add to more than 100%; 660 different terms appear across these reports. Malignant neoplasm progression is recorded in 11.4% of these reports, a larger share than in the median kinase inhibitor drug (2.5%).

97.5% of the reports are marked serious by the reporter (70.8% across the class); 20.7% record death among the outcomes and 44% record hospitalisation, as reported. 47.1% of the reports came from physicians, and the largest patient age group is 45 to 64 (28%). 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

04386Jul 2021: 7Aug 2021: 11Sep 2021: 8Oct 2021: 4Nov 2021: 86Dec 2021: 102022Jan 2022: 14Feb 2022: 6Mar 2022: 5Apr 2022: 10May 2022: 13Jun 2022: 10Jul 2022: 9Aug 2022: 7Sep 2022: 10Oct 2022: 8Nov 2022: 8Dec 2022: 152023Jan 2023: 11Feb 2023: 11Mar 2023: 3Apr 2023: 15May 2023: 8Jun 2023: 15Jul 2023: 15Aug 2023: 20Sep 2023: 21Oct 2023: 17Nov 2023: 35Dec 2023: 372024Jan 2024: 13Feb 2024: 25Mar 2024: 12Apr 2024: 20May 2024: 23Jun 2024: 11Jul 2024: 28Aug 2024: 17Sep 2024: 38Oct 2024: 25Nov 2024: 12Dec 2024: 82025Jan 2025: 19Feb 2025: 16Mar 2025: 31Apr 2025: 19May 2025: 9Jun 2025: 20Jul 2025: 13Aug 2025: 17Sep 2025: 14Oct 2025: 12Nov 2025: 7Dec 2025: 92026Jan 2026: 15Feb 2026: 11Mar 2026: 11Apr 2026: 26May 2026: 16Jun 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

02324642006: 220062007: 232008: 322009: 3020092010: 1682011: 2462012: 17220122013: 2682014: 4642015: 45420152016: 3342017: 2022018: 23520182019: 2772020: 2572021: 17320212022: 1152023: 2082024: 23220242025: 1862026: 92

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pazopanib reports recording the termmedian drug in kinase inhibitor

  1. Product use in unapproved indicationused for a purpose not on the label7.6%315
  2. Diarrhoealoose or frequent stools6.9%286
  3. Deaththe patient died; cause not stated by this term6.5%273
  4. Fatiguetiredness6.1%254
  5. Disease progressionthe disease advanced5.7%237
  6. Drug ineffectivethe medicine did not work as expected5.1%213
  7. Nauseafeeling sick5%209
  8. Hypertensionhigh blood pressure4.3%180
  9. Pyrexiafever4.1%171
  10. Vomitingbeing sick4%168
  11. Decreased appetitereduced appetite3.9%163
  12. Dyspnoeashortness of breath3.7%155
  13. Off label useused for a purpose or in a way not on the label3.3%136
  14. Alanine aminotransferase increasedraised liver enzyme (ALT)3.2%135
  15. Anaemialow red blood cells3.1%130
  16. Astheniaweakness or lack of energy3%126
  17. Thrombocytopenialow platelets2.9%121
  18. Abdominal painstomach or belly pain2.7%112
  19. Neutropenialow neutrophils, a type of white blood cell2.4%102
  20. Dehydrationdehydration2.4%99
  21. Drug interactionan interaction between medicines2.2%93
  22. Aspartate aminotransferase increasedraised liver enzyme (AST)2%83
  23. General physical health deteriorationgeneral decline in health2%82
  24. Pneumonialung infection1.9%80
  25. Malaisegeneral feeling of being unwell1.8%77
  26. Hepatotoxicityliver injury1.8%73

Top 30 of 660 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 100 drugs in the kinase inhibitor 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

Death20.7%863
Life-threatening5.5%231
Hospitalisation (initial or prolonged)44%1,835
Disability1%41
Congenital anomaly0%1
Other serious57.2%2,387
Not serious2.5%103

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 849,161 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 20.1%3
2 to 110.9%38
12 to 172%82
18 to 449.5%397
45 to 6428%1,169
65 to 7417.4%727
75 and over8.6%359
Age not given33.5%1,395

Patient sex

Female38.4%1,602
Male45.8%1,911
Not given15.8%657

Who reported

Physician47.1%1,965
Pharmacist2.4%100
Other health professional37.6%1,567
Lawyer0%1
Consumer or non-health professional10.6%444
Not given2.2%93

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 28.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Renal cell carcinoma79219%
Metastatic renal cell carcinoma2917%
Sarcoma1343.2%
Thyroid cancer1283.1%
Neoplasm1102.6%
Ovarian cancer952.3%

The indication field is filled in by the reporter and is often blank; shares are of all 4,170 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Pazopanib reports
Gemcitabine2345.6%
Doxorubicin2215.3%
Ifosfamide1734.1%
Docetaxel1583.8%
Paclitaxel1563.7%
Amlodipine1433.4%
Sunitinib1172.8%
Everolimus1122.7%
Aspirin1082.6%
Sorafenib962.3%

Other products listed in reports where Pazopanib 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

MeasurePazopanibKinase inhibitorAll reports
Reports as suspect product4,170849,16120,646,523
Share of that pool—0.5%0%
Reports, latest 12 months164—1,332,454
Marked serious97.5%70.8%57.4%
Death recorded among outcomes, per 1,000 reports20719091
Hospitalisation recorded, per 1,000 reports440264213
Consumer-filed share10.6%42.3%45.8%
Top term, share of reportsMalignant neoplasm progression 11.4%median 2.5%0.5%

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 kinase inhibitor class

DrugName typeReportsLatest 12 monthsMarked serious
Ibrancebrand81,9122,38047.1%
Imbruvicabrand67,0392,28374.4%
Cabometyxbrand41,8184,90440.4%
Sutentbrand33,21517574.5%
Afinitorbrand30,70616171.3%
Sprycelbrand27,25555749.7%
Tasignabrand24,91132870.9%
Kisqalibrand24,6033,41379.2%
Ofevbrand23,9072,43466.9%
Gleevecbrand23,1328174.7%
Tagrissobrand23,0851,41092.3%
Lenvimabrand22,3502,64387.3%
Votrientbrand22,08411960.9%
Mekinistbrand17,07091664%
Inlytabrand15,69638860.9%

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 Pazopanib reports

How many adverse event reports has FDA received for Pazopanib?

4,170 reports list Pazopanib as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 164 of them arrived in the latest 12 months. Another 335 list it only as a concomitant medication.

What reactions are recorded in Pazopanib reports?

malignant neoplasm progression (11.4%), product use in unapproved indication (7.6%), diarrhoea (6.9%), death (6.5%) and fatigue (6.1%). 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 Pazopanib was responsible.

How serious are the reports?

97.5% are marked serious by the reporter. Among the outcomes recorded, 20.7% of reports include death and 44% 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 (47.1%), other health professional (37.6%) and consumer or non-health professional (10.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Pazopanib rising?

164 reports in the 12 months to June 2026, down 32% from 242 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 Pazopanib 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 Pazopanib?

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 Pazopanib as a suspect or interacting product; reports listing it only as a concomitant medication (335) 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.