Sofosbuvir
Sofosbuvir is an antiviral ingredient used to treat chronic hepatitis C virus (HCV) infection in adults and certain children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important warning: Hepatitis B virus (HBV) can reactivate — flare up suddenly — in people who are being treated for hepatitis C with Sovaldi and who also carry HBV. This has happened even in people whose hepatitis B appeared to be fully resolved. When it does reactivate, it can cause severe liver inflammation, liver failure, and death. Before you start Sovaldi, your doctor must test your blood for signs of current or past HBV infection. If you have HBV, you must be monitored closely throughout HCV treatment and for some time afterward. Watch for warning signs like yellowing skin or eyes, dark urine, extreme tiredness, or stomach pain — and report them to your doctor right away.
📖 Sofosbuvir: Patient Information Guide
A plain-language walkthrough of Sofosbuvir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Sofosbuvir (brand name Sovaldi) is an antiviral used to treat chronic hepatitis C virus (HCV) infection. It is always part of a combination treatment — never used alone.
- Adults, genotype 1 or 4 HCV (with or without compensated cirrhosis): Sovaldi is used in combination with pegylated interferon and ribavirin.
- Adults, genotype 2 HCV (with or without compensated cirrhosis): Sovaldi is used in combination with ribavirin.
- Adults, genotype 3 HCV (with or without compensated cirrhosis): Sovaldi is used in combination with ribavirin.
- Adults with genotype 1 who cannot take interferon: Sovaldi plus ribavirin for 24 weeks may be considered.
- Adults with HCV-related hepatocellular carcinoma (liver cancer) awaiting liver transplant: Sovaldi is used with ribavirin for up to 48 weeks or until transplant, whichever comes first, to help prevent HCV recurrence after surgery.
- Children 3 years and older, genotype 2 or 3 HCV (with or without compensated cirrhosis): Sovaldi oral pellets or tablets are used in combination with ribavirin, with dosing based on the child's weight.
⚙️How it works▾
Sofosbuvir is a direct-acting antiviral that targets the hepatitis C virus directly. After you take it, your liver converts it into its active form — a molecule that blocks an enzyme the hepatitis C virus needs to make copies of itself, called NS5B polymerase. Without this enzyme working, the virus cannot replicate and spread. Because it targets a virus-specific enzyme rather than broad immune pathways, it can be highly effective with a focused side-effect profile.
Sofosbuvir must be used with other antiviral drugs because HCV can develop resistance; combination therapy attacks the virus at multiple points, making it much harder for resistance to emerge.
💊How it's taken▾
Sovaldi is taken by mouth once a day and can be taken with or without food — a high-fat meal does not meaningfully affect how the medicine is absorbed. Adults take the tablet form; children 3 and older take either tablets or oral pellets depending on their weight, as determined by their prescriber. The length of treatment varies by genotype and which other medicines are included in the regimen — follow your prescriber's plan exactly and do not stop early.
- Take Sovaldi at roughly the same time each day.
- Always combine it with the other antiviral medicines your doctor prescribed.
- If you miss a dose, ask your prescriber or pharmacist what to do — do not double up without guidance.
🤒Side effects — in detail▾
The most commonly reported side effects depend on which medicines Sovaldi is combined with:
- With ribavirin alone: fatigue and headache are most common.
- With pegylated interferon and ribavirin: fatigue, headache, nausea, trouble sleeping (insomnia), and anemia (low red blood cell count).
- In children using the oral solution with ribavirin: decreased appetite was the most common side effect noted.
Serious reactions to watch for and act on immediately include a very slow or irregular heartbeat (especially if you take amiodarone), signs of hepatitis B flare-up (yellowing skin or eyes, dark urine, severe fatigue), and signs of very low blood sugar if you have diabetes (shakiness, confusion, sweating).
⚠️Warnings & precautions▾
- Hepatitis B reactivation: If you carry the hepatitis B virus — even if it seemed inactive or resolved — starting HCV treatment with Sovaldi can cause HBV to suddenly flare. This has led to liver failure and death. You must be tested for HBV before starting, and monitored during and after treatment if any HBV markers are found.
- Dangerously slow heartbeat with amiodarone: Taking Sovaldi alongside amiodarone (a heart drug) has caused severe, life-threatening slow heartbeats and one fatal cardiac arrest. Coadministration is not recommended. If unavoidable, intensive heart monitoring is required.
- Drug interactions that reduce effectiveness: Certain drugs (rifampin, St. John's wort, some seizure medicines) lower sofosbuvir levels enough that treatment may fail. Avoid these while on Sovaldi.
- Combination therapy risks: Because Sovaldi is always taken with other antivirals, the warnings and contraindications for those medicines (ribavirin, pegylated interferon) also apply to your full treatment regimen.
🔀What it interacts with▾
Several medicines and supplements can interfere with how Sovaldi works or cause serious reactions when combined with it:
- Amiodarone (heart rhythm medicine): Can cause a dangerously slow heartbeat — this combination is not recommended.
- Rifampin (antibiotic): Strongly lowers sofosbuvir blood levels, making treatment less effective — avoid.
- St. John's wort (herbal supplement): Also lowers sofosbuvir levels through the same mechanism — avoid.
- Seizure medicines (carbamazepine, phenytoin, phenobarbital, oxcarbazepine): Reduce sofosbuvir concentrations — not recommended together.
- Rifabutin and rifapentine (related antibiotics): Lower sofosbuvir levels — avoid.
- Tipranavir/ritonavir (HIV medicine): Reduces sofosbuvir levels — not recommended together.
- Warfarin (blood thinner): Clearing HCV changes liver function; your clotting levels (INR) may shift and need more frequent testing.
- Diabetes medicines: Successfully treating HCV can lower blood sugar more than expected; dose adjustments and more frequent glucose monitoring may be needed.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B history: You must be tested for HBV before starting Sovaldi — tell your doctor about any past hepatitis B infection.
- Heart conditions or amiodarone use: Tell your doctor if you take any heart rhythm medicines or have underlying heart disease.
- All current medicines and supplements: Several common drugs (seizure medicines, certain antibiotics, St. John's wort) interfere with Sovaldi — share your full medication list.
- Pregnancy: When Sovaldi is combined with ribavirin or pegylated interferon/ribavirin, those combinations are contraindicated (not allowed) in pregnancy and require effective contraception during treatment. Consult the prescribing information for those combination drugs.
- Breastfeeding: It is unknown whether sofosbuvir or its metabolites pass into human breast milk — discuss risks and benefits with your doctor.
- Children under 3: Sovaldi's safety and effectiveness have not been established in this age group.
- Severe kidney disease / dialysis (ESRD): No dose recommendation can be given — speak with your doctor before starting.
- Liver disease (hepatic impairment): No dose adjustment is needed for mild, moderate, or severe liver impairment, but Sovaldi has not been fully studied in decompensated cirrhosis (advanced liver failure).
- Older adults (65+): No dose adjustment is needed; response rates are similar to those in younger patients.
🚑If you take too much▾
The highest single dose studied in healthy people was three times the normal dose, and no serious harmful effects were seen at that level. There is no specific antidote for a Sovaldi overdose. If an overdose occurs, medical staff will monitor vital signs and provide supportive care. A standard 4-hour session of hemodialysis (kidney dialysis) can remove a small portion of the drug.
📡Pharmacodynamics — effects in the body▾
Sofosbuvir blocks the hepatitis C virus's ability to copy itself by inhibiting a key viral enzyme (NS5B polymerase), which directly reduces the amount of virus in the body. At doses up to three times the normal amount, Sovaldi does not cause clinically meaningful changes in heart electrical conduction (specifically, it does not prolong the QTc interval — a measure of the heart's rhythm). This means it is unlikely to cause dangerous heart rhythm problems on its own through this mechanism.
🔬Pharmacokinetics — how your body processes it▾
After you take Sovaldi by mouth, it is absorbed quickly — peak blood levels occur within about half an hour to 2 hours. The medicine is extensively processed in the liver into its active form, and most of what circulates in the blood is actually its main breakdown product, GS-331007. The body clears sofosbuvir itself very quickly (half-life of about 0.4 hours), while GS-331007 stays in the system longer (half-life of about 27 hours). About 80% of the drug is eliminated through the urine, making kidney function an important consideration. Food does not significantly affect how much sofosbuvir is absorbed, so it can be taken with or without a meal.
📦How to store it▾
Store below 30 °C (86 °F).
📄 Written from Sofosbuvir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Sofosbuvir
55 supplements and herbal products have documented interactions with Sofosbuvir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 37
- Minor · 16
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Sofosbuvir — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Sovaldi do — is it a cure for hepatitis C? ▾
Can I take Sovaldi with food, or does it need to be on an empty stomach? ▾
I've heard Sovaldi interacts with a lot of medicines. What should I watch out for? ▾
Why do I need to be tested for hepatitis B before I start this? ▾
Is it safe to take Sovaldi during pregnancy? ▾
My child is 5 years old. Can they take Sovaldi? ▾
Is Sofosbuvir available over the counter? ▾
When was Sofosbuvir first available? ▾
Who makes Sofosbuvir? ▾
💬 Answers drafted from Sofosbuvir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Sofosbuvir comes
Sofosbuvir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Sovaldi tablets are used in adults to treat chronic hepatitis C genotype 1, 2, 3, or 4, with or without compensated cirrhosis, as part of a combination regimen.
- Sovaldi tablets are used in pediatric patients 3 years and older weighing 35 kg or more to treat chronic hepatitis C genotype 2 or 3.
- Sovaldi tablets are used with ribavirin in adults with HCV-related hepatocellular carcinoma awaiting liver transplantation.
- Sovaldi tablets are taken by mouth once daily, with or without food.
- Sovaldi tablets must always be taken in combination with other antiviral medicines (such as ribavirin, with or without pegylated interferon) as prescribed.
- Follow your prescriber's instructions for the complete treatment duration — do not stop early without talking to your doctor.
- Sovaldi tablets should be tested for HBV exposure before starting — your doctor will arrange this blood test.
Other oral form
How this form is used
- Sovaldi oral pellets are used in pediatric patients 3 years and older to treat chronic hepatitis C genotype 2 or 3, with or without compensated cirrhosis, in combination with ribavirin.
- Sovaldi oral pellets are used in pediatric patients based on body weight, with dosing determined by your child's prescriber.
- Sovaldi oral pellets should be prepared and given following the Instructions for Use provided with the medication.
- Sovaldi oral pellets are given once daily by mouth, with or without food.
- Sovaldi oral pellets must be used in combination with ribavirin as directed by your child's prescriber.
📊 Sofosbuvir across the U.S. market
How Sofosbuvir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Sofosbuvir products
A representative set of FDA-listed product records for Sofosbuvir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Other oral form | ||||
| 150 mg | Oral | Gilead Sciences, Inc. × 3 listings | NDA | View NDC → |
| 200 mg | Oral | Gilead Sciences, Inc. × 3 listings | NDA | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | Gilead Sciences, Inc. × 3 listings | NDA | View NDC → |
| 400 mg | Oral | Gilead Sciences, Inc. × 3 listings | NDA | View NDC → |
| 400 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | American Pacific Corporation | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Cambrex Charles City, Inc | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | F.i.s. Fabbrica Italiana Sintetici S.p.a. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | ST Pharm Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 20 of 20 products — FDA National Drug Code Directory. See every product, package size and price: browse all 20 Sofosbuvir NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sofosbuvir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sofosbuvir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Sofosbuvir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1484911 2 dose forms · 4 strengths
-
Dose form (SCDF) Oral Pellet RxCUI 2203992In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 1484915In current FDA listings
Look up RxCUI 1484911 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Sofosbuvir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Sofosbuvir belongs to the Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.