What the FDA labels say about taking them together
Fosamprenavir and itraconazole
Fosamprenavir's FDA label of September 15, 2023 names itraconazole in its drug interactions section, and itraconazole's label names fosamprenavir too. The fosamprenavir label: “Increase monitoring for adverse events. Fosamprenavir: Dose reduction of ketoconazole or itraconazole may be needed for patients receiving more than 400 mg ketoconazole or itraconazole per day. …”
Check it at the source: the fosamprenavir FDA label on DailyMed (effective September 15, 2023, Mylan Pharmaceuticals Inc.); the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.).
What does the fosamprenavir label say about itraconazole?
Fosamprenavir label, drug interactionsConcomitant Drug Class/Drug Name: Antifungals: Ketoconazole, itraconazole; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Ketoconazole ↑ Itraconazole; Clinical Comment: Increase monitoring for adverse events. Fosamprenavir: Dose reduction of ketoconazole or itraconazole may be needed for patients receiving more than 400 mg ketoconazole or itraconazole per day. Fosamprenavir/ritonavir: High doses of ketoconazole or itraconazole (greater than 200 mg/day) are not recommended.
Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed
What does the itraconazole label say about fosamprenavir?
Itraconazole label, drug interactionsExamples of Concomitant Drugs Within Class: Cobicistat Darunavir (ritonavir-boosted) Elvitegravir (ritonavir-boosted) Fosamprenavir (ritonavir-boosted) Indinavir Ombitasvir/ Paritaprevir/ Ritonavir with or without Dasabuvir Ritonavir Saquinavir; Prevention or Management: Monitor for adverse reactions. SPORANOX ® dose reduction may be necessary. For, cobicistat, elvitegravir, indinavir, ombitasvir/ paritaprevir/ ritonavir with or without dasabuvir, ritonavir, and saquinavir, see also.
Tolsura label (Mayne Pharma Commercial LLC, April 23, 2025), drug interactionsAntivirals Cobicistat Darunavir (ritonavir-boosted) Elvitegravir (ritonavir-boosted) Fosamprenavir (ritonavir-boosted) Indinavir Ritonavir Saquinavir Monitor for adverse reactions.
Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Fosamprenavir | Itraconazole | |
|---|---|---|
| Labeled for | HIV | Fungal infections |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | n/a | $0.910 per capsule 100 mg capsule |
| Shortage now | No current entry | A presentation being discontinued |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once