Prescription medicine
Emtricitabine and rilpivirine and tenofovir disoproxil Brand names: Complera
Emtricitabine and rilpivirine and tenofovir disoproxil (Complera) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $114.50 per emtricitabine-rilpivirine-tenofovir dis fum 200-25-300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the emtricitabine and rilpivirine and tenofovir disoproxil FDA label on DailyMed (effective July 16, 2025, Gilead Sciences, Inc.); the NDA 202123 record on Drugs@FDA; every emtricitabine and rilpivirine and tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of July 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageCOMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a sta
Forms and strengths
- 200 mg / 25 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 10, 2011 Complera, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first May 20, 2025; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 14, 2033 Complera tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $114.50 per tablet Emtricitabine-rilpivirine-tenofovir dis fum 200-25-300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,723 through July 30, 2026
What is emtricitabine and rilpivirine and tenofovir disoproxil used for?
From the label: indications and usageCOMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA [see Microbiology (12.4) and Clinical Studies (14) ]. […]
Conditions named in the indications of emtricitabine and rilpivirine and tenofovir disoproxil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (COMPLERA), Gilead Sciences, Inc., effective July 16, 2025 (SPL set d637cfab-f1e8-4eb3-a1b3-f85ca3bec612), via openFDA; the full label on DailyMed
Is there a generic for emtricitabine and rilpivirine and tenofovir disoproxil (Complera)?
The FDA approved the first generic emtricitabine and rilpivirine and tenofovir disoproxil on May 20, 2025. 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 emtricitabine and rilpivirine and tenofovir disoproxil from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Complera tablets, the last expiring on January 14, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2025 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for emtricitabine and rilpivirine and tenofovir disoproxil (Complera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $114.50 per Emtricitabine-rilpivirine-tenofovir dis fum 200-25-300 mg tablet. 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.
- Emtricitabine-rilpivirine-tenofovir dis fum 200-25-300 mg tablet (generic)
- Complera tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Emtricitabine-rilpivirine-tenofovir dis fum 200-25-300 mg tablet | Generic | $114.50 per tablet | $3,435.09 | n/a |
| Complera tablet | Brand | $130.31 per tablet | $3,909.43 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the emtricitabine and rilpivirine and tenofovir disoproxil label say about other medicines?
The emtricitabine and rilpivirine and tenofovir disoproxil label names 52 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Acetaminophen | drug interactions | No clinically significant drug interactions have been observed between RPV and the following medications: acetaminophen, atorvastatin, chlorzoxazone, ethinyl estradiol, ledipasvir/sofosbuvir, norethindrone, sildenafil, simeprevir, sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or TDF. |
| Acyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Adefovir dipivoxil | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Atorvastatin | drug interactions | No clinically significant drug interactions have been observed between RPV and the following medications: acetaminophen, atorvastatin, chlorzoxazone, ethinyl estradiol, ledipasvir/sofosbuvir, norethindrone, sildenafil, simeprevir, sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or TDF. |
| Azithromycin | drug interactions | … RPV ↔ clarithromycin ↔ erythromycin ↔ telithromycin; Clinical Comment: Where possible, alternatives such as azithromycin should be considered. |
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum, magnesium hydroxide, or calcium carbonate); Effect on Concentration Increase = ↑; Decrease = ↓; No Effect = ↔: ↔ RPV (antacids taken at least 2 hours before or at least 4 hours after RPV) ↓ RPV (concomitant intake); … |
| Carbamazepine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Chlorzoxazone | drug interactions | No clinically significant drug interactions have been observed between RPV and the following medications: acetaminophen, atorvastatin, chlorzoxazone, ethinyl estradiol, ledipasvir/sofosbuvir, norethindrone, sildenafil, simeprevir, sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or TDF. |
| Cidofovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Cimetidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase = ↑; Decrease = ↓; No Effect = ↔: ↔ RPV, (famotidine taken 12 hours before RPV or 4 hours after RPV) ↓ RPV, (famotidine taken 2 hours before RPV); … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or Ketolide Antibiotics: clarithromycin erythromycin telithromycin; Effect on Concentration Increase = ↑; Decrease = ↓; No Effect = ↔: ↑ RPV ↔ clarithromycin ↔ erythromycin ↔ telithromycin; … |
| Dexamethasone | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Dexlansoprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when coadministered with drugs which may result in loss of virologic response and possible resistance to COMPLERA. |
| Digoxin | drug interactions | RPV did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
Every other medicine the emtricitabine and rilpivirine and tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Efavirenz | warnings and precautions | … (regardless of causality, severity) reported among RPV (n=686) or efavirenz (EFV, n=682) was 9% and 8%, respectively. Most events were mild or moderate in severity. |
| Entecavir | drug interactions | No clinically significant drug interactions have been observed between TDF and the following medications: entecavir, methadone, oral contraceptives, ribavirin, sofosbuvir, or tacrolimus in studies … |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or Ketolide Antibiotics: clarithromycin erythromycin telithromycin; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Esomeprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when … |
| Famciclovir | drug interactions | Interactions with COMPLERA No clinically significant drug interactions have been observed between FTC and the following medications: famciclovir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir … |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Fluconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Ganciclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir … |
| Gentamicin | drug interactions | … ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Lansoprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when … |
| Ledipasvir and sofosbuvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum, magnesium hydroxide, or calcium carbonate); Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Metformin | drug interactions | RPV did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic Analgesics: methadone; Effect on Concentration Increase = ↑; Decrease = ↓; No Effect = ↔: ↓ R(–) methadone ↓ S(+) methadone ↔ RPV ↔ methadone (when used … |
| Nizatidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Norethindrone | drug interactions | … atorvastatin, chlorzoxazone, ethinyl estradiol, ledipasvir/sofosbuvir, norethindrone, sildenafil, simeprevir, sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or TDF. |
| Omeprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when … |
| Oxcarbazepine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Pantoprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when … |
| Phenobarbital | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Phenytoin | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Posaconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Rabeprazole | contraindications | St John's wort ( Hypericum perforatum ) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole COMPLERA is contraindicated when … |
| Ranitidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Ribavirin | drug interactions | No clinically significant drug interactions have been observed between TDF and the following medications: entecavir, methadone, oral contraceptives, ribavirin, sofosbuvir, or tacrolimus in studies … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: rifabutin; Effect on Concentration Increase = ↑; Decrease = ↓; No Effect = ↔: ↓ RPV The interaction was evaluated in a clinical study. … |
| Rifampin | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Rifapentine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Sildenafil | drug interactions | … chlorzoxazone, ethinyl estradiol, ledipasvir/sofosbuvir, norethindrone, sildenafil, simeprevir, sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or TDF. |
| Sofosbuvir | drug interactions | Concomitant Drug Class/Drug Name: Hepatitis C Antiviral Agents: ledipasvir/sofosbuvir sofosbuvir/velpatasvir sofosbuvir/velpatasvir/voxilaprevir; Effect on Concentration Increase = ↑; Decrease = ↓; … |
| Sofosbuvir and velpatasvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tacrolimus | drug interactions | … entecavir, methadone, oral contraceptives, ribavirin, sofosbuvir, or tacrolimus in studies conducted in healthy subjects. |
| Valacyclovir | drug interactions | … limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions … |
| Valganciclovir | drug interactions | … acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Voriconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase = ↑; Decrease = ↓; … |
Check emtricitabine and rilpivirine and tenofovir disoproxil against other medicines
Source: FDA drug label (COMPLERA), Gilead Sciences, Inc., effective July 16, 2025 (SPL set d637cfab-f1e8-4eb3-a1b3-f85ca3bec612), via openFDA; the full label on DailyMed
What do FAERS reports show for emtricitabine and rilpivirine and tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 6,723 reports that list emtricitabine and rilpivirine and tenofovir disoproxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 85 are coded as a death and 405 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 rose sharply in 2020 (3,139, against a median of 199 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 emtricitabine and rilpivirine and tenofovir disoproxil?
29 other medicines are given the same way (oral) and in the same FDA class as emtricitabine and rilpivirine and tenofovir disoproxil 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 |
|---|---|---|---|---|
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 mg tablet | No current entry |
| Efavirenz | HIV | 5 labelers | $1.28 per tablet 600 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Abacavir and lamivudine | HIV | 6 labelers | $1.48 per unit 600-300 mg | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to emtricitabine and rilpivirine and tenofovir disoproxil
- 29 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Emtricitabine and rilpivirine and tenofovir disoproxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other