Prescription medicine
Raltegravir Brand names: Isentress; first approved as Isentress Hd
Raltegravir (Isentress) is a prescription medicine with an FDA approval on record since 2007. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $34.54 per Isentress 400 mg tablet.
- Generic approved
Check it at the source: the raltegravir FDA label on DailyMed (effective October 18, 2024, Merck Sharp & Dohme LLC); the NDA 22145 record on Drugs@FDA; every raltegravir label on DailyMed.
Highlights of the record
FDA label of October 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAdult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ).
Forms and strengths
- 25 mg
- 100 mg
- 400 mg
- 600 mg
Film-coated tablet; chewable tablet; granule for suspension.
On the market
- Earliest approval on file
- October 12, 2007 Isentress Hd, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 19, 2024; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 1 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- March 30, 2032 Isentress tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $34.54 per tablet Isentress 400 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 16,416 through July 30, 2026
What is raltegravir used for?
From the label: indications and usageAdult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ). Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ( 1 ). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg ( 1 ). […]
Conditions named in the indications of raltegravir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor.
Source: FDA drug label (ISENTRESS), Merck Sharp & Dohme LLC, effective October 18, 2024 (SPL set 89a5ec53-d956-4329-8004-0f40f51c88a3), via openFDA; the full label on DailyMed
Is there a generic for raltegravir (Isentress)?
The FDA approved the first generic raltegravir on December 19, 2024. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists raltegravir from 1 labeler under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 5 patents for Isentress tablets: the compound patent runs to June 2, 2030, and the last listed entry to March 30, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2024 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for raltegravir (Isentress)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $34.54 per Isentress 400 mg tablet, up 2% from $33.78 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Isentress hd 600 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Isentress 400 mg tablet | Brand | $34.54 per tablet | $1,036.17 | +2% |
| Isentress hd 600 mg tablet | Brand | $34.52 per tablet | $1,035.45 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has raltegravir been recalled?
The FDA's Enforcement Report lists 1 recall naming raltegravir since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of raltegravir and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the raltegravir label say about other medicines?
The raltegravir label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name raltegravir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | … midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. Moreover, atazanavir, atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not have a clinically meaningful effect on the … |
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Calcium carbonate antacid; Effect on Concentration of Raltegravir: ↓; Clinical Comment for ISENTRESS: No dose adjustment; Clinical Comment for ISENTRESS HD: Co-administration is not recommended |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Strong inducers of drug metabolizing enzymes not mentioned above e.g., Carbamazepine Phenobarbital Phenytoin; Effect on Concentration of Raltegravir: ↓↔; Clinical Comment for ISENTRESS: The impact of other strong inducers of drug metabolizing enzymes on raltegravir is unknown. … |
| Darunavir | drug interactions | … ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. Moreover, atazanavir, atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not … |
| Efavirenz | drug interactions | … boceprevir. Moreover, atazanavir, atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not have a clinically meaningful effect on the pharmacokinetics of 400 mg twice daily raltegravir. … |
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name: Etravirine; Effect on Concentration of Raltegravir: ↓; Clinical Comment for ISENTRESS: No dose adjustment; Clinical Comment for ISENTRESS HD: Coadministration is not recommended. |
| Lamivudine | drug interactions | … meaningful effect on the pharmacokinetics of the following: ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. … |
| Methadone | drug interactions | … have a clinically meaningful effect on the pharmacokinetics of the following: ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. … |
| Midazolam | drug interactions | … clinically meaningful effect on the pharmacokinetics of the following: ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. … |
| Omeprazole | drug interactions | … atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not have a clinically meaningful effect on the pharmacokinetics of 400 mg twice daily raltegravir. … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Strong inducers of drug metabolizing enzymes not mentioned above e.g., Carbamazepine Phenobarbital Phenytoin; Effect on Concentration of Raltegravir: ↓↔; Clinical Comment for ISENTRESS: The impact of other strong inducers of drug metabolizing enzymes on raltegravir is unknown. … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Strong inducers of drug metabolizing enzymes not mentioned above e.g., Carbamazepine Phenobarbital Phenytoin; Effect on Concentration of Raltegravir: ↓↔; Clinical Comment for ISENTRESS: The impact of other strong inducers of drug metabolizing enzymes on raltegravir is unknown. … |
| Rifampin | drug interactions | Coadministration of ISENTRESS or ISENTRESS HD with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir ( 2.1 , 7.1 ). |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: Tipranavir/ritonavir; Effect on Concentration of Raltegravir: No dose adjustment; Clinical Comment for ISENTRESS: Coadministration is not recommended |
Every other medicine the raltegravir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Tenofovir alafenamide | drug interactions | … no predicted pharmacokinetic drug interaction between ISENTRESS and tenofovir alafenamide. ISENTRESS HD In drug interaction studies, efavirenz did not have a clinically meaningful effect on the … |
| Tenofovir disoproxil | drug interactions | … ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. … |
Other labels that name raltegravir
Source: FDA drug label (ISENTRESS), Merck Sharp & Dohme LLC, effective October 18, 2024 (SPL set 89a5ec53-d956-4329-8004-0f40f51c88a3), via openFDA; the full label on DailyMed
What do FAERS reports show for raltegravir?
The FDA Adverse Event Reporting System holds 16,416 reports that list raltegravir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,634 are coded as a death and 5,029 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as raltegravir?
44 other medicines are given the same way (oral) and in the same FDA class as raltegravir or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dolutegravir | HIV | none listed | $77.64 per tablet 50 mg tablet | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
| Cabotegravir | HIV | none listed | n/a | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide | HIV | none listed | $143.35 per tablet Genvoya tablet | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil | HIV | none listed | $150.14 per tablet Stribild tablet | No current entry |
| Dolutegravir and lamivudine | HIV | none listed | $105.22 per tablet 50-300 mg tablet | No current entry |
| Dolutegravir and rilpivirine | HIV | none listed | $121.87 per tablet 50-25 mg tablet | No current entry |
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as raltegravir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to raltegravir
- 44 medicines for the same use
- Other human immunodeficiency virus integrase strand transfer inhibitors
- the pharmacologic class, with prices and generics
- Raltegravir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other