Pentoxifylline
Pentoxifylline is a blood-flow medicine used to treat leg pain with walking (intermittent claudication) caused by chronic blocked arteries in the limbs.
🧬 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 7 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 →
Pentoxifylline (Trental) is an older, modest-strength drug for intermittent claudication (cramping leg pain with walking from blocked leg arteries) that makes blood less thick and red blood cells more flexible; on the market since about 1984 and available as a generic, it eases symptoms but is no substitute for procedures that reopen arteries. Most people tolerate it reasonably well, though stomach upset (indigestion, nausea, belching or bloating) is common, along with some dizziness or headache. The one thing to watch for is bleeding, so make sure every prescriber knows if you take warfarin, another blood thinner or an NSAID such as ibuprofen.
Clinical pearls
- Take it with meals, and swallow the extended-release tablet whole, never crushed, chewed or split.
- Benefit may start within 2 to 4 weeks, but give it at least 8 weeks before judging whether your walking improves.
- If you take theophylline for asthma or COPD, pentoxifylline can push its levels up, so expect a blood level check.
- Kidney or liver disease lets pentoxifylline build up, so mention either before starting; severe kidney problems call for a lower dose.
Patient information guide A plain-language walkthrough of Pentoxifylline, written from its FDA label.
What Pentoxifylline is used for
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Pentoxifylline is used for one main condition.
- Pentoxifylline extended-release tablets (oral) treat intermittent claudication caused by chronic occlusive arterial disease of the limbs.
- They can improve function and symptoms but do not replace surgical bypass or removal of arterial blockages.
How Pentoxifylline works
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Pentoxifylline and its metabolites (breakdown products) make blood less thick, so it flows more easily. In chronic peripheral arterial disease, this increases blood flow to the smallest blood vessels and improves tissue oxygen.
The precise way it works is still not fully defined.
Pentoxifylline dosage
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Pentoxifylline extended-release tablets are swallowed by mouth, usually three times a day with meals. Benefit may appear in 2 to 4 weeks, but treatment is recommended for at least 8 weeks.
- If stomach or nervous system side effects occur, your prescriber may lower the frequency.
- If side effects continue at the lower dose, the medicine should be stopped.
- People with severe kidney impairment take a reduced dose.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Pentoxifylline prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Usual dosage (extended-release tablet)
- One tablet (400 mg) three times a day with meals
- Effect may be seen within 2 to 4 weeks; continue treatment for at least 8 weeks
- Patients who develop digestive or central nervous system side effects
- Lower the dosage to one tablet twice a day (800 mg/day)
- If side effects persist at this lower dosage, discontinue
- Severe renal impairment (creatinine clearance below 30 mL/min)
- Reduce dose to 400 mg once a day
- Renal impairment adjustment
- Hepatic impairment
- Dosing information cannot be provided
Read the label’s full dosing text
DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration. Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline extended-release tablets should be discontinued. In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.
Read the full Dosage and Administration section on DailyMed →
Pentoxifylline side effects
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In clinical trials of the extended-release tablets, side effects were fairly uncommon. The most often reported were:
Common side effects
- Indigestion (dyspepsia)
- Nausea
- Dizziness
- Headache
- Vomiting
- Belching, gas or bloating
When to get medical help
- Call your doctor right away if you have signs of bleeding, since bleeding has been reported with this medicine.
- Get emergency help for signs of a severe allergic reaction, such as swelling, hives or trouble breathing.
- Call your doctor if you have chest pain, a racing or irregular heartbeat, or a seizure.
- Report yellowing of the skin or eyes (jaundice), or other possible liver problems.
- Tell your doctor if stomach or nervous system side effects continue despite a lower dose.
- Seek emergency care after an overdose. Signs include flushing, low blood pressure, convulsions, drowsiness, fainting, fever and agitation.
Pentoxifylline warnings and precautions
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- Bleeding: bleeding has been reported, with or without NSAIDs, anticoagulants or platelet inhibitors.
- Allergic reactions: severe reactions have been reported rarely.
- Liver impairment: drug levels rose several-fold, and dosing information cannot be provided.
- Kidney impairment: a breakdown product builds up, so severe impairment needs a lower dose.
- Blood pressure: small drops have been seen.
Pentoxifylline interactions
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Several medicines can interact with pentoxifylline.
- Warfarin and other vitamin K antagonists: clotting time can increase.
- NSAIDs, anticoagulants, platelet inhibitors: bleeding has been reported.
- Theophylline: levels can rise and cause toxicity.
- Ciprofloxacin, fluvoxamine: may raise pentoxifylline exposure.
- Cimetidine: raises pentoxifylline levels.
- Blood pressure medicines: pressure may drop a little, so monitoring is advised.
Interactions listed in the FDA-approved label
From the Pentoxifylline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- NSAIDs, anticoagulants, or platelet aggregation inhibitors: Bleeding has been reported in patients treated with pentoxifylline with or without these concomitant drugs.
- Vitamin K antagonists: Increased prothrombin time and increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline. Monitor anticoagulant activity when pentoxifylline is introduced or the dose is changed.
- Theophylline-containing drugs: Concomitant administration leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline or changing dose.
- Strong CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May increase the exposure to pentoxifylline.
- Antihypertensive drugs: Small decreases in blood pressure have been observed in some patients treated with pentoxifylline. Periodic systemic blood pressure monitoring is recommended; if indicated, reduce the dosage of the antihypertensive agents.
- Beta blockers, digitalis, diuretics, and antiarrhythmics: Used concurrently with pentoxifylline without observed problems.
- Cimetidine: Reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and Metabolite I (~30%).
Read the label’s full interactions text
DRUG INTERACTIONS Bleeding has been reported in patients treated with pentoxifylline extended-release tablets with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration of pentoxifylline extended-release tablets and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline extended-release tablets or changing dose. Concomitant administration of strong CYP1A2 inhibitors (including e.g., ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ADVERSE REACTIONS). Pentoxifylline extended-release tablets have been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline extended-release tablets; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced. Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Pentoxifylline
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- Do not use after a recent brain or retinal hemorrhage (bleeding).
- Do not use if you are intolerant of pentoxifylline or methylxanthines such as caffeine, theophylline or theobromine.
- Tell your prescriber about kidney or liver disease.
- Older adults had higher drug levels in a small study.
Pentoxifylline overdose
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Overdose has been reported in children and adults. Symptoms, which appear related to the amount taken, usually started 4 to 5 hours after ingestion and lasted about 12 hours. They included flushing, low blood pressure, convulsions, drowsiness, fainting, fever and agitation. All patients in one report recovered. Treatment is supportive, and activated charcoal has been used. Seek emergency help.
What Pentoxifylline does in the body
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Pentoxifylline lowers blood viscosity (thickness) and makes red blood cells more flexible, in a dose-related way. It also increases white blood cell flexibility and reduces neutrophil sticking and activation. In people with peripheral arterial disease, tissue oxygen levels rise significantly at therapeutic doses.
How your body processes Pentoxifylline
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Pentoxifylline is almost completely absorbed after oral use and is processed quickly by the body. With the extended-release tablet, blood levels peak in 2 to 4 hours and stay steady over time. Taking it with meals modestly increases levels. The drug itself has a short half-life of under an hour, and its active metabolites last 1 to 1.6 hours. It is cleared almost entirely in the urine as metabolites.
How to store Pentoxifylline
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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Pentoxifylline
218 supplements and herbal products have documented interactions with Pentoxifylline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 190
- Minor · 25
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.
Pentoxifylline: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Pentoxifylline — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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What side effects should I expect?
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Can I take it with my other medicines?
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Who shouldn't take it?
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Is Pentoxifylline available over the counter?
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When was Pentoxifylline first available?
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Who makes Pentoxifylline?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Pentoxifylline on HelloPharmacist
Pentoxifylline forms and strengths (how it comes)
Pentoxifylline 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Pentoxifylline inactive ingredients by manufacturer.
Extended-release tablet
How this form is used
- Pentoxifylline extended-release tablets treat intermittent claudication from chronic occlusive arterial disease of the limbs.
- Pentoxifylline extended-release tablets are usually taken three times a day with meals.
- Pentoxifylline extended-release tablets may help within 2 to 4 weeks, and treatment is recommended for at least 8 weeks.
- Pentoxifylline extended-release tablets may be lowered to twice daily if stomach or nervous system side effects occur.
- Pentoxifylline extended-release tablets need a lower dose in severe kidney impairment.
Pentoxifylline on the U.S. market: products, makers and brands
How Pentoxifylline 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.
6 companies list 7 Pentoxifylline product records with the FDA, mostly as extended-release tablet; the earliest marketing or approval year on record is 1984. Brand names on the directory include Pentoxil, Trental; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (9) — 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.
How widely Pentoxifylline is used (Medicaid data)
A general measure of how commonly Pentoxifylline 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 Pentoxifylline 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.
How commonly is Pentoxifylline prescribed? Of the 1,601 medications we measure, Pentoxifylline ranks #557 by Medicaid prescriptions — more than 65% of them.
Utilization by Pentoxifylline 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.
pentoxifylline 400 MG Extended Release Oral Tablet
Summed across the 7 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312301
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 Pentoxifylline, 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 7 of 35 listed Pentoxifylline NDCs with Medicaid activity.
Compare Pentoxifylline products
A representative set of FDA-listed product records for Pentoxifylline — 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 |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 400 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 400 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 400 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 400 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Pentoxifylline NDCs →
Pentoxifylline side effects reported to the 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 Pentoxifylline — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Pentoxifylline are fatigue, diarrhoea, dyspnoea; about 82% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
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 Pentoxifylline 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.
Pentoxifylline FDA approval history
How Pentoxifylline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Pentoxifylline was first approved by the FDA in 1984 (Brand: TRENTAL · Validus Pharms); the first generic version was approved in 1997. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Pentoxifylline 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.
The FDA’s enforcement reports list no Pentoxifylline recalls since July 2021.
✅No Pentoxifylline recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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 8013 2 dose forms · 2 strengths
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Dose form (SCDF) Extended Release Oral Tablet RxCUI 373287In current FDA listingsClinical drug / strength (SCD) 400 MGRxCUI 312301 -
Dose form (SCDF) Oral Tablet RxCUI 393498No current FDA listingClinical drug / strength (SCD) 400 MGRxCUI 392124
Look up RxCUI 8013 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.
Pentoxifylline supply and shortage status
Whether Pentoxifylline 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.
Pentoxifylline brand names
Pentoxifylline is sold under 2 brand names in the FDA directory — Pentoxil, Trental. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Pentoxifylline: manufacturers and labelers
6 companies list Pentoxifylline products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Apotex Corp.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Pentoxifylline drug class (RxNorm)
Pentoxifylline belongs to the Blood Viscosity Reducer 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.
Sources for this Pentoxifylline page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Major Pharmaceuticals is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →