Prescription medicine
Emtricitabine Brand names: Emtriva
Emtricitabine (Emtriva) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $12.69 per emtricitabine 200 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the emtricitabine FDA label on DailyMed (effective December 2, 2025, Gilead Sciences, Inc.); the NDA 21500 record on Drugs@FDA; every emtricitabine label on DailyMed.
Highlights of the record
FDA label of December 2, 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 (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. 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 (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued EMTRIVA. Hepatic function should be monitored closely in patients coinfected with HIV-1 and HBV who discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageEMTRIVA ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Forms and strengths
- 200 mg
- 10 mg/ml
Capsule; solution.
On the market
- Earliest approval on file
- July 2, 2003 Emtriva, Gilead; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first July 2, 2018; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $12.69 per capsule Emtricitabine 200 mg capsule
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest October 1, 2014
- FAERS reports
- 7,176 through July 30, 2026
What is emtricitabine used for?
From the label: indications and usageEMTRIVA ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. EMTRIVA, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Conditions named in the indications of emtricitabine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Emtriva), Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed
What does the patient leaflet for emtricitabine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EMTRIVA?EMTRIVA can cause serious side effects, including: Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment with EMTRIVA. If you have HBV infection and take EMTRIVA, your HBV may get worse (flare-up) if you stop taking EMTRIVA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not stop taking EMTRIVA without first talking to your healthcare provider. Do not run out of EMTRIVA. Refill your prescription or talk to your healthcare provider before your EMTRIVA is all gone. If you stop taking EMTRIVA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medication to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking EMTRIVA. For more information about side effects, see the section " What are the possible side effects of EMTRIVA? " What is EMTRIVA? EMTRIVA is a prescription medicine used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Who should not take EMTRIVA? Do not take EMTRIVA if you are allergic to emtricitabine or any of the ingredients in EMTRIVA. See the end of this leaflet for a complete list of ingredients in EMTRIVA.
From the patient leaflet: How should I store EMTRIVA?Store EMTRIVA capsules at room temperature between 68°F to 77°F (20°C to 25°C). Store EMTRIVA oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. You may also store EMTRIVA oral solution at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months. Throw away any unused EMTRIVA oral solution after 3 months. Keep EMTRIVA in its original container and keep the container tightly closed. Do not use EMTRIVA if seal over bottle opening is broken or missing. Keep EMTRIVA and all other medicines out of reach of children.
Source: FDA drug label (Emtriva), Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed
Is there a generic for emtricitabine (Emtriva)?
The FDA approved the first generic emtricitabine on July 2, 2018. 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. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists emtricitabine 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.
- 2003 earliest approval on file
- 2018 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for emtricitabine (Emtriva)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12.69 per Emtricitabine 200 mg capsule, down 13% from $14.51 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.
- Emtricitabine 200 mg capsule (generic)
- Emtriva 200 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Emtricitabine 200 mg capsule | Generic | $12.69 per capsule | $380.60 | -13% |
| Emtriva 200 mg capsule | Brand | $17.45 per capsule | $523.38 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is emtricitabine in shortage?
No emtricitabine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated June 17, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Emtriva, Capsule, 200 mg (NDC 61958-0601-1) | Gilead Sciences, Inc. | To Be Discontinued | June 17, 2026 |
| Emtriva, Oral Solution, 10 mg/1 mL (NDC 61958-0602-1) | Gilead Sciences, Inc. | To Be Discontinued | June 17, 2026 |
Every emtricitabine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has emtricitabine been recalled?
The FDA's Enforcement Report lists 1 recall naming emtricitabine since 2014: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 1, 2014 | Class II | Gilead Sciences, Inc. | Defective Container; leaking around the cap |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the emtricitabine label say about other medicines?
The emtricitabine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 17 other medicines name emtricitabine. 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 |
|---|---|---|
| Famciclovir | drug interactions | DRUG INTERACTIONS The potential for drug interactions with EMTRIVA has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). |
Other labels that name emtricitabine
Source: FDA drug label (Emtriva), Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed
What do FAERS reports show for emtricitabine?
The FDA Adverse Event Reporting System holds 7,176 reports that list emtricitabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 889 are coded as a death and 2,157 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 emtricitabine?
35 other medicines are given the same way (oral) and in the same FDA class as emtricitabine 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 |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| 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 |
| 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 |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as emtricitabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to emtricitabine
- 35 medicines for the same use
- Other human immunodeficiency virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Emtricitabine side effects
- the label's list beside FAERS reports
- Emtricitabine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other