Reported Reactions

Drug classes

Pharmacologic class (EPC) · 2 drug pages

Complement 5a receptor antagonist: adverse event reports filed with FDA

6,196 reports list a drug in this class as a suspect or interacting product, 2021–2026.

6,196
reports across the class
0% of all reports
2,091
reports, 12 months to June 2026
1,390 in the 12 months before
72.8%
marked serious by the reporter
57.4% across all reports
2
drugs with a page
brand and generic names counted separately

Complement 5a receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 6,196 adverse event reports received by FDA, 0% of the database, from September 2021 to June 2026.

2,091 reports arrived in the 12 months to June 2026, up 50% from 1,390 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 72.8% of the class's reports are marked serious, 10.1% record death among the outcomes and 45.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are hospitalisation (15%), death (6.1%) and off label use (4.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

DrugName typeReportsLatest 12 monthsMarked seriousTop term recorded
TavneosAvacopanbrand5,6271,88470.7%Hospitalisation
Avacopangeneric56920793.7%Off label use

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."

Reports by month, five years

0170340Jul 2021: 0Aug 2021: 0Sep 2021: 2Oct 2021: 0Nov 2021: 0Dec 2021: 12022Jan 2022: 9Feb 2022: 8Mar 2022: 7Apr 2022: 65May 2022: 13Jun 2022: 13Jul 2022: 114Aug 2022: 28Sep 2022: 14Oct 2022: 129Nov 2022: 33Dec 2022: 232023Jan 2023: 208Feb 2023: 33Mar 2023: 53Apr 2023: 340May 2023: 156Jun 2023: 147Jul 2023: 112Aug 2023: 143Sep 2023: 110Oct 2023: 126Nov 2023: 113Dec 2023: 1152024Jan 2024: 127Feb 2024: 92Mar 2024: 91Apr 2024: 95May 2024: 107Jun 2024: 88Jul 2024: 93Aug 2024: 87Sep 2024: 99Oct 2024: 132Nov 2024: 108Dec 2024: 862025Jan 2025: 121Feb 2025: 134Mar 2025: 129Apr 2025: 133May 2025: 133Jun 2025: 135Jul 2025: 109Aug 2025: 134Sep 2025: 156Oct 2025: 166Nov 2025: 149Dec 2025: 1662026Jan 2026: 176Feb 2026: 194Mar 2026: 214Apr 2026: 205May 2026: 196Jun 2026: 226

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

  1. Hospitalisationadmission to hospital15%928
  2. Deaththe patient died; cause not stated by this term6.1%379
  3. Off label useused for a purpose or in a way not on the label4.9%302
  4. Diarrhoealoose or frequent stools4.1%251
  5. Fatiguetiredness3.9%242
  6. Nauseafeeling sick3.8%236
  7. Pneumonialung infection3.5%216
  8. Headachehead pain2.7%170
  9. Covid-19COVID-19 infection2.6%164
  10. Product dose omission issuea dose was missed2.5%154
  11. Dialysisdialysis2.2%135
  12. Infectionan infection, type not specified2.2%135
  13. Dyspnoeashortness of breath2%122
  14. Rashskin rash2%122
  15. Drug ineffectivethe medicine did not work as expected1.9%119
  16. Illness1.7%107
  17. Dizzinesslight-headedness or unsteadiness1.7%104
  18. Unevaluable eventthe event could not be assessed1.7%104
  19. Vomitingbeing sick1.6%99
  20. Hypertensionhigh blood pressure1.6%97
  21. Abdominal discomfortstomach discomfort1.5%95

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.1%628
Life-threatening1.8%112
Hospitalisation (initial or prolonged)45.8%2,836
Disability0.4%27
Congenital anomaly0%0
Other serious27%1,670
Not serious27.2%1,683

Patient age

Under 20.2%12
2 to 110.1%6
12 to 170.5%32
18 to 448.4%520
45 to 6420.3%1,260
65 to 7418.7%1,160
75 and over23%1,424
Age not given28.8%1,782

Who reported

Physician22.3%1,381
Pharmacist5.6%347
Other health professional15.2%944
Lawyer0%0
Consumer or non-health professional32.8%2,033
Not given24.1%1,491

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Complement 5a receptor antagonist reports

Which drugs are in the Complement 5a receptor antagonist class on this site?

Tavneos and Avacopan. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

6,196 reports through June 2026, 2,091 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

hospitalisation (15%), death (6.1%), off label use (4.9%), therapy interrupted (4.6%) and diarrhoea (4.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.