Prescription medicine
Abacavir Brand names: Ziagen
Abacavir (Ziagen) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.546 per abacavir 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the abacavir FDA label on DailyMed (effective July 17, 2025, Mylan Institutional Inc.); the NDA 20977 record on Drugs@FDA; every abacavir label on DailyMed.
Highlights of the record
FDA label of July 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HYPERSENSITIVITY REACTIONS.
Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions (5.1) ]. Abacavir tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1) ]. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir or reinitiation of therapy with abacavir, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir tablets immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications (4), Warnings and Precautions (5.1) ]. Following a hypersensitivity reaction to abacavir, NEVER restart abacavir tablets or any other abacavir-containing product because more severe symptoms, including death can occur within hours. […]
Used for
From the label: indications and usageAbacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Forms and strengths
- 300 mg
- 20 mg/ml
Film-coated tablet; solution; tablet.
On the market
- Earliest approval on file
- December 17, 1998 Ziagen, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first June 18, 2012; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.546 per tablet Abacavir 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,685 through July 30, 2026
What is abacavir used for?
From the label: indications and usageAbacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Conditions named in the indications of abacavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Abacavir Sulfate), Mylan Institutional Inc., effective July 17, 2025 (SPL set 80c1702a-973c-436a-90f8-69b29674dca0), via openFDA; the full label on DailyMed
What does the patient leaflet for abacavir 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 abacavir tablets?Abacavir tablets can cause serious side effects, including: Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir tablets and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets. Symptom(s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop abacavir tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM ® , TRIUMEQ ® , or TRIZIVIR ® ) again. If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines. If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking them again. Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to them before. […]
From the patient leaflet: How should I store abacavir tablets?Store abacavir tablets at room temperature, between 20° to 25°C (68° to 77°F). Keep abacavir tablets and all medicines out of the reach of children. General information for safe and effective use of abacavir tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets for a condition for which they were not prescribed. Do not give abacavir tablets to other people, even if they have the same symptoms that you have. They may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir tablets that is written for health professionals. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
Source: FDA drug label (Abacavir Sulfate), Mylan Institutional Inc., effective July 17, 2025 (SPL set 80c1702a-973c-436a-90f8-69b29674dca0), via openFDA; the full label on DailyMed
Is there a generic for abacavir (Ziagen)?
The FDA approved the first generic abacavir on June 18, 2012. 8 generic applications are approved; 7 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 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists abacavir from 12 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.
- 1998 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for abacavir (Ziagen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.546 per Abacavir 300 mg tablet, down 19% from $0.671 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.
- Abacavir 300 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Abacavir 300 mg tablet | Generic | $0.546 per tablet | $16.37 | -19% |
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 abacavir label say about other medicines?
The abacavir label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name abacavir. 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 |
|---|---|---|
| Methadone | drug interactions | DRUG INTERACTIONS Methadone: An increased methadone dose may be required in a small number of patients. |
| Riociguat | drug interactions | The riociguat dose may need to be reduced. |
Other labels that name abacavir
Source: FDA drug label (Abacavir Sulfate), Mylan Institutional Inc., effective July 17, 2025 (SPL set 80c1702a-973c-436a-90f8-69b29674dca0), via openFDA; the full label on DailyMed
What do FAERS reports show for abacavir?
The FDA Adverse Event Reporting System holds 9,685 reports that list abacavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,180 are coded as a death and 3,297 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 abacavir?
41 other medicines are given the same way (oral) and in the same FDA class as abacavir 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 |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| 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 |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to abacavir
- 41 medicines for the same use
- Other human immunodeficiency virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Abacavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other