Pharmacologic class (EPC) · 8 drug pages
Cytochrome P450 3A inhibitor: adverse event reports filed with FDA
46,425 reports list a drug in this class as a suspect or interacting product, 2004–2026.
- 46,425
- reports across the class
- 0.2% of all reports
- 546
- reports, 12 months to June 2026
- 1,050 in the 12 months before
- 87.2%
- marked serious by the reporter
- 57.4% across all reports
- 8
- drugs with a page
- brand and generic names counted separately
Cytochrome P450 3A inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 46,425 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.
546 reports arrived in the 12 months to June 2026, down 48% from 1,050 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 87.2% of the class's reports are marked serious, 9% record death among the outcomes and 26% record hospitalisation, as reported.
Across the class the reactions recorded most often are bone density decreased (10.2%), drug interaction (9.7%) and renal injury (7.4%). 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 |
|---|---|---|---|---|---|
| Ritonavir | generic | 11,399 | 164 | 92% | Drug interaction |
| KaletraLopinavir and ritonavir | brand | 9,419 | 57 | 92.5% | Drug interaction |
| NorvirRitonavir | brand | 8,821 | 44 | 92.8% | Foetal exposure during pregnancy |
| StribildElvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate | brand | 8,754 | 124 | 86.3% | Bone density decreased |
| Lopinavir and ritonavir | generic | 3,003 | 9 | 96.7% | Off label use |
| GenvoyaElvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | brand | 2,994 | 57 | 50.6% | Drug interaction |
| SymtuzaDarunavir, cobicistat, emtricitabine, and tenofovir alafenamide | brand | 1,067 | 64 | 56.8% | Death |
| PrezcobixDarunavir ethanolate and cobicistat | brand | 968 | 27 | 54.4% | Foetal 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
- Bone density decreased10.2%4,740
- Drug interactionan interaction between medicines9.7%4,522
- Renal injury7.4%3,426
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine7%3,271
- Skeletal injury6.7%3,115
- Chronic kidney diseaselong-term kidney disease5.8%2,679
- Renal failurekidney failure5.7%2,658
- Tooth loss5.5%2,544
- Osteonecrosis5.4%2,509
- Bone loss4.8%2,248
- Off label useused for a purpose or in a way not on the label4.7%2,160
- Anxietyanxiety4.6%2,158
- Painpain, site not specified4.5%2,111
- Osteoporosisthinning of the bones4.5%2,091
- Multiple fractures4.4%2,051
- Tooth injury4.3%1,976
- Emotional distressemotional distress4%1,866
- Diarrhoealoose or frequent stools3.6%1,670
- Anhedonia3.6%1,669
- Depressionlow mood3.5%1,606
- Nauseafeeling sick3.1%1,446
- Exposure during pregnancythe medicine was taken during pregnancy3%1,381
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2.9%1,367
- Acute kidney injurysudden loss of kidney function2.9%1,340
- Osteopenia2.5%1,154
Solid bar: share of all class reports. Hollow bar: the median share across the 8 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 Cytochrome P450 3A inhibitor reports
Which drugs are in the Cytochrome P450 3A inhibitor class on this site?
Ritonavir, Kaletra, Norvir, Stribild, Lopinavir and ritonavir and Genvoya and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.
How many reports does the class have?
46,425 reports through June 2026, 546 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?
bone density decreased (10.2%), drug interaction (9.7%), renal injury (7.4%), foetal exposure during pregnancy (7%) and skeletal injury (6.7%).
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.