Pharmacologic class (EPC) · 6 drug pages
Protease inhibitor: adverse event reports filed with FDA
22,331 reports list a drug in this class as a suspect or interacting product, 2004–2026.
- 22,331
- reports across the class
- 0.1% of all reports
- 274
- reports, 12 months to June 2026
- 491 in the 12 months before
- 88.5%
- marked serious by the reporter
- 57.4% across all reports
- 6
- drugs with a page
- brand and generic names counted separately
Protease inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 22,331 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.
274 reports arrived in the 12 months to June 2026, down 44% from 491 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88.5% of the class's reports are marked serious, 8.8% record death among the outcomes and 27.9% record hospitalisation, as reported.
Across the class the reactions recorded most often are foetal exposure during pregnancy (10.4%), drug interaction (10.3%) and maternal exposure during pregnancy (5.6%). 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
| Drug | Name type | Reports | Latest 12 months | Marked serious | Top term recorded |
|---|---|---|---|---|---|
| PrezistaDarunavir | brand | 6,264 | 128 | 82% | Foetal exposure during pregnancy |
| ReyatazAtazanavir | brand | 5,181 | 5 | 83.9% | Foetal exposure during pregnancy |
| Darunavir | generic | 4,460 | 86 | 94.4% | Foetal exposure during pregnancy |
| Atazanavir | generic | 2,725 | 28 | 94% | Drug interaction |
| Atazanavir sulfate | generic | 2,621 | 22 | 95.3% | Drug interaction |
| ViraceptNelfinavir mesylate | brand | 1,080 | 5 | 92.7% | Drug exposure during pregnancy |
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
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
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine10.4%2,320
- Drug interactionan interaction between medicines10.3%2,296
- Maternal exposure during pregnancythe mother took the medicine during pregnancy5.6%1,252
- Depressionlow mood5.4%1,211
- Exposure during pregnancythe medicine was taken during pregnancy4%896
- Abortion spontaneousmiscarriage3.5%785
- Premature babya baby born early3.2%722
- Diarrhoealoose or frequent stools2.7%592
- Virologic failure2.6%591
- Drug exposure during pregnancythe medicine was taken during pregnancy2.6%584
- Nauseafeeling sick2.6%577
- Drug resistance2.4%536
- Deaththe patient died; cause not stated by this term2.4%529
- Nephrolithiasiskidney stones2.2%482
- Lipodystrophy acquiredchanges in body fat distribution2.1%470
- Anaemialow red blood cells2.1%459
- Pyrexiafever2%439
- Vomitingbeing sick1.9%430
- Off label useused for a purpose or in a way not on the label1.9%421
- Rashskin rash1.8%408
- Treatment noncompliancethe treatment was not taken as directed1.7%378
- Drug ineffectivethe medicine did not work as expected1.6%368
- Hyperbilirubinaemia1.6%366
- Device issuea problem with the device1.6%359
- Blood bilirubin increased1.6%358
Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.
Outcomes, patients and reporters
Outcomes recorded
Patient age
Who reported
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 Protease inhibitor reports
Which drugs are in the Protease inhibitor class on this site?
Prezista, Reyataz, Darunavir, Atazanavir, Atazanavir sulfate and Viracept. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.
How many reports does the class have?
22,331 reports through June 2026, 274 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?
foetal exposure during pregnancy (10.4%), drug interaction (10.3%), maternal exposure during pregnancy (5.6%), depression (5.4%) and exposure during pregnancy (4%).
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.