FDA-filed SPL labeling · retrieved through openFDA

Cidofovir Injection

Cidofovir is an antiviral medication given by intravenous infusion to treat CMV retinitis (a serious eye infection caused by cytomegalovirus) in people with AIDS.

Brand name Vistide
Drug class Cytomegalovirus Nucleoside Analog Dna Polymerase Inhibitor
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 2 clinical label sets 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 →

At a glance
Linked label effectiveApr 15, 2021
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 1996
FDA-listed product records 3
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Cidofovir Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cidofovir injection is a potent antiviral reserved for CMV retinitis in people with AIDS, and it carries serious risks — especially kidney damage — that require close medical monitoring before and during every dose. It must always be given with IV fluids and probenecid to help protect the kidneys, and it cannot be used in patients with pre-existing kidney problems or alongside other kidney-toxic drugs. This is a hospital- or clinic-administered treatment; your care team will monitor you closely throughout.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Serious kidney damage — including acute kidney failure requiring dialysis — can happen after just one or two doses of cidofovir. To reduce this risk, every infusion must be paired with intravenous saline (IV fluids) and the drug probenecid taken by mouth. Kidney function must be tested within 48 hours before every dose. Cidofovir must not be used alongside other drugs that can harm the kidneys. Cidofovir can also lower your white blood cell count (neutropenia), so blood counts need to be checked regularly. In animal studies, cidofovir caused cancer, birth defects, and reduced sperm production. Cidofovir is approved only for CMV retinitis in people with AIDS.

Read the full warning on DailyMed →

📖 Cidofovir Injection: Patient Information Guide

A plain-language walkthrough of Cidofovir Injection — 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

Cidofovir injection is an antiviral used for one specific, serious indication:

  • CMV retinitis in people with AIDS: CIDOFOVIR injection is approved to treat cytomegalovirus (CMV) retinitis — a viral infection of the retina that can cause blindness — in adults who have AIDS.
  • It is not approved for CMV pneumonia, CMV gastrointestinal disease, congenital (newborn) CMV disease, or CMV infections in people who are not HIV-positive.
⚙️How it works

Cidofovir targets the CMV virus directly. Inside cells, it is converted to its active form — cidofovir diphosphate — which blocks the viral enzyme (CMV DNA polymerase) the virus needs to replicate its genetic material. By inserting itself into the growing viral DNA chain, it slows and disrupts viral replication. Importantly, cidofovir diphosphate inhibits the viral enzyme at concentrations far lower than those needed to affect human cell enzymes, giving it some selectivity for the virus.

💊How it's taken

Cidofovir is given as an IV infusion in a clinic or hospital setting — never at home, never by mouth, and never directly into the eye. Treatment is typically divided into an induction phase (more frequent infusions) and a maintenance phase (less frequent). Every dose must be accompanied by oral probenecid and IV saline fluids to protect the kidneys, and kidney function must be tested within 48 hours before each infusion.

  • Doses are adjusted or stopped if kidney function changes
  • Your prescriber and care team will set your exact schedule — follow it closely
🤒Side effects — in detail

Cidofovir causes side effects in most people who receive it. The most common include:

  • Protein in the urine (often the earliest kidney warning sign)
  • Nausea and vomiting
  • Fever and chills
  • Neutropenia (low white blood cell count, raising infection risk)
  • Weakness and fatigue
  • Headache
  • Rash
  • Diarrhea
  • Hair loss (alopecia)
  • Anemia (low red blood cell count)

Serious reactions — including acute kidney failure, very low eye pressure causing vision changes, severe metabolic acidosis, and liver or pancreas problems — require immediate medical attention.

⚠️Warnings & precautions
  • Kidney damage (nephrotoxicity): This is the biggest risk. Acute kidney failure has occurred after just one or two doses and has been fatal. Kidney tests are mandatory before every dose, and the drug must be stopped or reduced if function declines.
  • Low white blood cell count (neutropenia): Can increase the risk of serious infections. Blood counts must be monitored throughout treatment.
  • Decreased eye pressure (ocular hypotony): Can reduce visual acuity; people with diabetes may be at higher risk. Eye pressure should be checked regularly.
  • Metabolic acidosis and Fanconi's syndrome: Cidofovir can damage the kidney's filtering tubules, causing chemical imbalances in the blood. Fatal cases involving liver failure and pancreatitis have been reported.
  • Cancer, birth defects, and fertility: Animal studies showed cidofovir is carcinogenic, teratogenic, and causes reduced sperm production. Discuss these risks with your doctor.
🔀What it interacts with

Cidofovir has critical drug interactions — some are absolute contraindications:

  • Other nephrotoxic drugs (IV aminoglycosides like tobramycin, gentamicin, and amikacin; amphotericin B; foscarnet; IV pentamidine; vancomycin; NSAIDs): must be stopped at least 7 days before starting cidofovir — combining them is contraindicated due to severe kidney damage risk
  • Probenecid (given with every cidofovir dose): interacts with many common drugs including acetaminophen, acyclovir, methotrexate, furosemide, theophylline, benzodiazepines, and barbiturates — your whole medication list needs to be reviewed
  • Zidovudine (AZT): probenecid raises zidovudine levels, so zidovudine must be stopped or its dose cut in half on each day of cidofovir infusion

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
  • Do not use if your kidneys are already significantly impaired (lab values will be checked before starting)
  • Do not use if you are allergic to cidofovir, probenecid, or sulfa-containing medications
  • Tell your doctor about every medication you take — especially any that can affect kidney function
  • Animal data showed cidofovir causes birth defects and reduced sperm production; discuss pregnancy and fertility concerns with your doctor before starting
  • Effects of cidofovir in older adults, by gender, or by race have not been specifically studied
  • Cidofovir injection must never be injected directly into the eye — this causes serious, potentially permanent eye damage including blindness
  • Prior use of foscarnet has been linked to higher nephrotoxicity risk with cidofovir — tell your doctor if you have taken foscarnet
🚑If you take too much

Two cases of cidofovir overdose have been reported, in which patients received much higher-than-recommended single doses. Both patients were hospitalized and treated with oral probenecid and vigorous IV saline hydration for several days. Neither patient experienced significant kidney function changes. If an overdose is suspected, seek emergency medical care immediately.

📡Pharmacodynamics — effects in the body

Cidofovir's key measurable effect is suppression of CMV replication in the retina, which slows or halts progression of CMV retinitis. In clinical trials, patients receiving the higher maintenance dose had significantly longer time to retinitis progression compared to those receiving a lower dose or deferred therapy. The drug also lowers white blood cell counts and can reduce pressure inside the eye — both of which require monitoring during treatment.

🔬Pharmacokinetics — how your body processes it

Cidofovir is given intravenously and is excreted largely unchanged in urine within 24 hours — about 80–100% of the dose when given without probenecid. It binds very little to proteins in the blood (less than 6%). The kidneys clear cidofovir partly through active tubular secretion; probenecid blocks this secretion, which slows elimination and is why probenecid must always be co-administered. In patients with reduced kidney function, cidofovir clearance drops proportionally, and high-flux hemodialysis can remove about 75% of the drug from the blood.

📦How to store it

stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

📄 Written from Cidofovir Injection’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 →

10

Supplements & herbs that interact with Cidofovir Injection

10 supplements and herbal products have documented interactions with Cidofovir Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 7
  • Minor · 1
Every supplement checked against Cidofovir Injection — ranked by severity The full interaction hub: 2 major · 7 moderate · 1 minor · every one linked to its full report. Check Cidofovir Injection against your exact supplements

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 Cidofovir Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is cidofovir used for?
Cidofovir is used to treat CMV retinitis — a serious eye infection caused by a virus called cytomegalovirus — in people who have AIDS. Left untreated, CMV retinitis can lead to blindness. Cidofovir helps slow or stop the infection from getting worse. It's only approved for this specific use in AIDS patients, not for other CMV infections or for people who don't have HIV.
How is this medication given? Do I take it at home?
No — cidofovir is given as an IV infusion, meaning it goes directly into your vein through a drip in a clinic or hospital. You won't be taking a pill at home. Each time you get cidofovir, you'll also need to take an oral medication called probenecid and receive IV saline fluids to protect your kidneys. Never let anyone inject cidofovir directly into your eye — that is extremely dangerous and can cause permanent vision damage.
What are the most important side effects I should know about?
The biggest concern with cidofovir is kidney damage — it can be serious and sometimes permanent, even after just one or two doses. That's why your kidneys are tested before every infusion. Other common issues include nausea, fever, and low white blood cell counts (which can raise your infection risk). Tell your care team right away if you notice less urination than usual, swelling, eye pain, changes in vision, or feel unusually short of breath or confused — these can be signs of serious problems.
Are there any medications I absolutely cannot take with cidofovir?
Yes — several drugs must be stopped at least a week before you start cidofovir because combining them can cause severe kidney damage. These include certain antibiotics given by IV (like gentamicin or tobramycin), antifungal drugs like amphotericin B, foscarnet, IV pentamidine, vancomycin, and regular anti-inflammatory painkillers like ibuprofen or naproxen. Also, if you take zidovudine (AZT), the dose needs to be cut in half on the days you get cidofovir infusions. Make sure your whole care team knows every medication you're on.
Why do I need to take probenecid every time I get cidofovir?
Probenecid helps protect your kidneys. Cidofovir is cleared from the body through the kidneys, partly through a process that can be hard on kidney cells. Probenecid slows down that process, reducing how much damage the drug can cause. It's not optional — it must be taken with every single infusion. Just be aware that probenecid itself interacts with many common medications, so your pharmacist and doctor should review your full medication list.
Is cidofovir safe if I'm pregnant or trying to have children?
This is a serious concern to discuss with your doctor before starting cidofovir. In animal studies, cidofovir caused birth defects and reduced sperm production. These findings mean there are real potential risks for pregnancy and fertility in humans, though human data are limited. If you are pregnant, planning to become pregnant, or concerned about fertility, have an honest conversation with your doctor about the risks and benefits before treatment begins.
Is Cidofovir Injection available over the counter?
Cidofovir Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Cidofovir Injection first available?
Cidofovir Injection has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cidofovir Injection?
Cidofovir Injection is supplied by 2 manufacturers listed in the FDA NDC Directory, including Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Mylan Institutional LLC.

💬 Answers drafted from Cidofovir Injection’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 Cidofovir Injection comes

Cidofovir Injection is available in 1 form. 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.

Injection

Into a vein
How this form is used
What it may be used for
  • CIDOFOVIR injection is used to treat CMV retinitis (a CMV-caused eye infection) in adults with AIDS
  • CIDOFOVIR injection is not approved for other CMV infections, newborn CMV disease, or CMV in people without HIV
Important instructions
  • CIDOFOVIR injection is given as an intravenous (IV) infusion by a healthcare provider — never injected directly into the eye
  • CIDOFOVIR injection must be diluted in 100 mL of normal saline before each infusion
  • Oral probenecid and IV saline prehydration must accompany every CIDOFOVIR infusion to protect the kidneys
  • Kidney function (creatinine and urine protein) must be checked within 48 hours before each CIDOFOVIR dose
Available strengths 2 strengths
3 FDA-listed product records

📊 Cidofovir Injection across the U.S. market

How Cidofovir Injection 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.

1
Dose forms
2
Manufacturers
2
Brand names
3
FDA-listed product records
1996
First marketed
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.67%
Mylan Institutional LLC33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Cidofovir Injection is used

A general measure of how commonly Cidofovir Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cidofovir Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

127
Medicaid prescriptions filled (Q1–Q4 2025)
$120,089 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cidofovir Injection prescribed? Of the 1,596 medications we measure, Cidofovir Injection ranks #1,481 by Medicaid prescriptions — more than 7% of them.

Where Cidofovir Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cidofovir Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

5 ML cidofovir 75 MG/ML Injection

127 Medicaid prescriptions (Q1–Q4 2025) 100% of Cidofovir Injection prescriptions shown $120,089 gross reimbursement (before rebates) ≈ $946 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199388

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cidofovir Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Cidofovir Injection NDCs with Medicaid activity.

🔍 Compare Cidofovir Injection products

A representative set of FDA-listed product records for Cidofovir Injection — 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
💊Injection
375 mg/5 mL Intravenous Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. × 2 listings ANDA View NDC →
75 mg/mL Intravenous Mylan Institutional LLC ANDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Cidofovir Injection NDCs →

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.

Ingredient (IN) Cidofovir Injection RxCUI 83171 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1731046 In current FDA listings
    Clinical drug / strength (SCD) 5 ML cidofovir 75 MG/ML RxCUI 199388

Look up RxCUI 83171 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.

🏷️ Sold under these brand names

Vistide

🏭 Manufacturers & labelers

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2 Mylan Institutional LLC 1

RxNorm drug class

Cidofovir Injection belongs to the Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
How it works DNA Polymerase Inhibitors

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 15, 2021
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cidofovir Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cidofovir Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
3
Distinct labelers/manufacturers represented
2
Linked representative label
Mylan Institutional LLC
Linked label effective
Apr 15, 2021
Composite sections available
20
Linked SPL Set ID
56541229-8c1a-4550-8951-2415ed08e7e9
Linked SPL Document ID
e7774227-c6ba-439d-a32f-01b67d010fc5
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets 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.

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. Mylan Institutional LLC 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.