NDC 62135-0606-90 — Propylthiouracil 50 mg Tablet, 90-count

🆔 Identity & classification

FDA NDC (as labeled) 62135-606-90

Product NDC 62135-606

11-digit billing NDC 62135060690

NCPDP billing unit EA — each (per item)

RxCUI 198175

UNII 721M9407IY

UPC 0362135606909

Application # ANDA080016

SPL Set ID 53c5f586-3e72-479d-89ba-379683c8f6ba

Established class (EPC) Thyroid Hormone Synthesis Inhibitor

Mechanism of action Thyroid Hormone Synthesis Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1982-01-01

Route ORAL

Dosage form TABLET

Substance PROPYLTHIOURACIL

GPI-14 28300020000310

GCN Seq No 006673

GCN 26391

HICL code 002854

Ingredient (HICL) Propylthiouracil

HIC1 code P

Therapeutic class — broad (HIC1) Endocrine System

HIC2 code P3

Therapeutic class — intermediate (HIC2) Drugs Affecting Thyroid Function

HIC3 code P3L

Therapeutic class — specific (HIC3) Antithyroid Preparations

AHFS code 68:36.08.00

AHFS class Antithyroid Agents

FDB label name PROPYLTHIOURACIL 50 MG TABLET

FDB brand name Propylthiouracil

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 62135-606-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0606-90. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Thyroid Hormone Synthesis Inhibitor class.

Pharmacologic class Thyroid Hormone Synthesis Inhibitor

Drug family (ATC) Thiouracils

How it works Thyroid Hormone Synthesis Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerChartwell RX, LLC

Application holderCHARTWELL MOLECULAR HOLDINGS LLC

FDA applicationANDA080016 (ANDA)

Labeler code62135

First marketedJan 1982

Product typeHuman Prescription Drug

Portfolio521 products on file

🔎 All NDCs from Chartwell RX, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PROPYLTHIOURACIL 50 MG TABLET Ingredient Propylthiouracil

📗 Our plain-language guide HelloPharmacist

Propylthiouracil is typically prescribed when the first-choice antithyroid drug — methimazole — isn't right for you, and when surgery or radioactive iodine therapy isn't an option...
Why was I prescribed propylthiouracil instead of a different thyroid medication?
You'll usually take propylthiouracil three times a day, spaced about 8 hours apart, to keep your thyroid levels steady around the clock. The label doesn't specify that food is requ...
How do I take this medication — should I take it with food?

📖 Read our full Propylthiouracil guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.269	$24.18 / 90 tablets
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.4050	$36.45 / 90 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 3% over the last 10 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Propylthiouracil 50 mg 00480-9242-01	Teva	100 tablets	$0.269	—	Availability likely	—
Propylthiouracil 50 mg 33342-0314-11	Macleods	100 tablets	$0.269	AB	Availability likely	—
Propylthiouracil 50 mgthis 62135-0606-90	Chartwell	90 tablets	$0.269	—	Availability likely	—
Propylthiouracil 50 mg 67253-0651-10	Par	100 tablets	$0.269	AB	Availability likely	—
Propylthiouracil 50 mg 68084-0964-25	American	30 tablets	$0.269	AB	Availability likely	—
Propylthiouracil 50 mg 70752-0171-10	QUAGEN	100 tablets	$0.269	BD	Availability likely	—
Propylthiouracil 50 mg 71335-2901-01	Bryant	100 tablets	—	BD	FDA listed	—
Propylthiouracil 50 mg 72162-2072-01	Bryant	100 tablets	—	BD	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

1982

On the market since

Jan 1982

📍

2026

Currently FDA-listed

44 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Propylthiouracil — the program that covers self-administered drugs. 5 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Propylthiouracil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$433.1K

Claims incl. refills

9.3K

Beneficiaries

6.3K

Spend / beneficiary

$69.27

Spend / claim

$46.39

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
62135-0606-90 You're viewing this	90 TABLET in 1 BOTTLE (62135-606-90)	2023-12-19	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	✓ Available
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 62135-606-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62135-0606-90, written without dashes as 62135060690. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 62135-0606-90, the first segment (62135) is the labeler code FDA assigned to Chartwell RX, LLC; the middle segment (0606) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Chartwell RX, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Chartwell RX, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide

🚨 Boxed Warning 90 words ▾

WARNING Severe liver injury and acute liver failure, in some cases fatal, have been reported in patients treated with propylthiouracil. These reports of hepatic reactions include cases requiring liver transplantation in adult and pediatric patients. Propylthiouracil should be reserved for patients who cannot tolerate methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments for the management of hyperthyroidism.

Propylthiouracil may be the treatment of choice when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy (see Warnings and Precautions ).

🎯 Indications and Usage 56 words ▾

INDICATIONS AND USAGE Propylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Propylthiouracil is administered orally. The total daily dosage is usually given in 3 equal doses at approximately 8-hour intervals. Adults The initial dose is 300 mg daily.

In patients with severe hyperthyroidism, very large goiters, or both, the initial dose may be increased to 400 mg daily; an occasional patient will require 600 to 900 mg daily initially. The usual maintenance dose is 100 to 150 mg daily. Pediatric Patients Propylthiouracil is generally not recommended for use in the pediatric patient population except in rare instances in which other alternative therapies are not appropriate options.

Studies evaluating appropriate dosing regimen have not been conducted in the pediatric population although general practice would suggest initiation of therapy in patients 6 years or older at a dosage of 50 mg daily with careful upward titration based on clinical response and evaluation of TSH and free T4 levels. Although cases of severe liver injury have been reported with doses as low as 50 mg/day, most cases were associated with doses of 300 mg/day and higher. Geriatric Patients Clinical studies of propylthiouracil did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

⚠️ Warnings ~2 min read ▾

WARNINGS Liver Toxicity Liver injury resulting in liver failure, liver transplantation, or death, has been reported with propylthiouracil therapy in adult and pediatric patients. No cases of liver failure have been reported with the use of methimazole in pediatric patients. For this reason, propylthiouracil is not recommended for pediatric patients except when methimazole is not well-tolerated and surgery or radioactive iodine therapy are not appropriate therapies.

Biochemical monitoring of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT, AST) is not expected to attenuate the risk of severe liver injury due to its rapid and unpredictable onset. Patients should be informed of the risk of liver failure. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.), particularly in the first six months of therapy.

When these symptoms occur, propylthiouracil should be discontinued immediately and liver function tests and ALT and AST levels obtained. Use in Pregnancy There are cases of liver injury, including liver failure and death, in women treated with propylthiouracil during pregnancy. Two reports of in utero exposure with liver failure and death of a newborn have been reported.

If propylthiouracil is used during pregnancy, or if the patient becomes pregnant while taking propylthiouracil, the patient should be warned of the rare potential hazard to the mother and fetus of liver damage. Propylthiouracil crosses the placenta and can cause fetal goiter and cretinism when administered to a pregnant woman (see Precautions, Pregnancy ). After the first trimester of pregnancy, the use of an alternative antithyroid medication may be advisable (see Precautions, Pregnancy ).

Agranulocytosis Agranulocytosis occurs in approximately 0.2% to 0.5% of patients and is a potentially life-threatening side effect of propylthiouracil therapy. Agranulocytosis typically occurs within the first 3 months of therapy. Patients should be instructed to immediately report any symptoms suggestive of agranulocytosis, such as fever or sore throat.

Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. Propylthiouracil should be discontinued if agranulocytosis, aplastic anemia (pancytopenia) is suspected, and the patient's bone marrow indices should be obtained. Vasculitis Cases of vasculitis resulting in severe complications and death have been reported in patients receiving propylthiouracil therapy.

The cases of vasculitis include: glomerulonephritis, leukocytoclastic cutaneous vasculitis, alveolar/pulmonary hemorrhage, cerebral angiitis, and ischemic colitis. Most cases were associated with anti-neutrophilic cytoplasmic antibodies (ANCA)-positive vasculitis. In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis.

If vasculitis is suspected, discontinue therapy and initiate appropriate intervention. Hypothyroidism Propylthiouracil can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, propylthiouracil can cause fetal goiter and cretinism when administered to a pregnant woman (see Precaution, Pregnancy ).

🤒 Adverse Reactions 185 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported with the use of propylthiouracil. Because these events generally come from voluntary reporting from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Severe adverse reactions include liver injury presenting as hepatitis, liver failure necessitating liver transplantation or resulting in death (see WARNINGS ).

Inhibition of myelopoiesis (agranulocytosis, granulopenia, aplastic anemia, and thrombocytopenia), drug fever, a lupus-like syndrome (including splenomegaly and vasculitis), periarteritis, hypoprothrombinemia, and bleeding have been reported. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis, and erythema nodosum have also been reported. There are reports of a vasculitis associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications and death (see WARNINGS ).

There have been rare reports of serious hypersensitivity reactions (e.g., Stevens Johnson syndrome and toxic epidermal necrolysis) in patients treated with propylthiouracil. Other adverse reactions include skin rash, uticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesias, loss of taste, taste perversion, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy.

🆘 Overdosage 140 words ▾

OVERDOSAGE Signs and Symptoms Nausea, vomiting, epigastric distress, headache, fever, arthralgia, pruritus, edema, and pancytopenia. Agranulocytosis is the most serious effect. Rarely, exfoliative dermatitis, hepatitis, neuropathies or CNS stimulation or depression may occur.

No information is available on the following: LD 50 ; concentration of propylthiouracil in biologic fluids associated with toxicity and/or death; the amount of drug in a single dose usually associated with symptoms of overdosage; or the amount of propylthiouracil in a single dose likely to be life-threatening. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

🧬 Clinical Pharmacology 101 words ▾

CLINICAL PHARMACOLOGY Propylthiouracil inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and triiodothyronine that are stored in the thyroid or circulating in the blood, nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. Propylthiouracil inhibits the conversion of thyroxine to triiodothyronine in peripheral tissues and may therefore be an effective treatment for thyroid storm.

Propylthiouracil is readily absorbed and is extensively metabolized. Approximately 35% of the drug is excreted in the urine, in intact and conjugated forms, within 24 hours.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Propylthiouracil Tablets, USP 50 mg, are white to off white, round scored tablets, debossed with “CE” above bisect “134” on one side and plain on other side. NDC 62135-606-90 Bottle of 90 tablets Store at controlled room temperature 15° to 30°C (59° to 86°F).

📋 Description 62 words ▾

DESCRIPTION Propylthiouracil, USP is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil, USP is an antithyroid drug administered orally. The structural formula is: Each tablet contains propylthiouracil, USP 50 mg and the following inactive ingredients: calcium stearate, corn starch, lactose monohydrate and pregelatinized starch. image description

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE PROPYLTHIOURACIL (Pro-pil-thi-o-ur-a-sil) Tablets Read this Medication Guide before you start taking Propylthiouracil and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Propylthiouracil? Propylthiouracil can cause serious side effects, including: Severe liver problems. In some cases, liver problems can happen in people who take Propylthiouracil including: liver failure, the need for liver transplant, or death.

Stop taking Propylthiouracil and call your doctor right away if you have any of these symptoms: • fever • itchiness • loss of appetite • pain or tenderness in your right upper stomach area (abdomen) • nausea • dark (tea colored) urine • vomiting • pale or light colored bowel movements (stools) • tiredness • yellowing of your skin or whites of your eyes Serious risks during pregnancy. Propylthiouracil may cause liver problems, liver failure and death in pregnant women and may harm your unborn baby. Propylthiouracil may also cause liver problems or death of infants born to women who take Propylthiouracil during certain trimesters of pregnancy.

Propylthiouracil may be used when an antithyroid drug is needed during or just before the first trimester of pregnancy. If you get pregnant while taking Propylthiouracil, call your doctor right away about your therapy. What is Propylthiouracil?

Propylthiouracil is a prescription medicine used to treat people who have Graves’ disease with hyperthyroidism or toxic multinodular goiter. Propylthiouracil is used when: certain other antithyroid medicines do not work well. thyroid surgery or radioactive iodine therapy is not a treatment option. to decrease symptoms of hyperthyroidism in preparation for a thyroidectomy (removal of the thyroid gland) or radioactive iodine therapy. Propylthiouracil is not recommended for use in children.

Who should not take Propylthiouracil? Do not take Propylthiouracil if you are allergic to Propylthiouracil or any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in Propylthiouracil.

What should I tell my doctor before taking Propylthiouracil? Before you take Propylthiouracil, tell your doctor if you: plan to have surgery. have any other medical conditions are pregnant or plan to become pregnant. Talk to your doctor right away if you are pregnant or plan to become pregnant.

Propylthiouracil may harm or cause death of your unborn baby. are breast-feeding or plan to breast-feed. Propylthiouracil can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Propylthiouracil.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Propylthiouracil may affect the way other medicines work. Especially, tell your doctor if you take: a blood thinner medicine warfarin sodium (Coumadin, Jantoven) medicine for heart problems medicine for high blood pressure Digoxin (Lanoxicaps, Lanoxin) Theophylline (Elixophyllin, Theolair, Theochron, Theo-24, Uniphyl) Ask your doctor if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take Propylthiouracil?

Take Propylthiouracil exactly as your doctor tells you to take it. Your doctor may change your dose if needed. Propylthiouracil is usually taken 3 times a day (every 8 hours).

If you take too much Propylthiouracil, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away. If you take too much Propylthiouracil you may have the following symptoms: nausea, vomiting, upper stomach pain or tenderness, headache, fever, joint pain, and swelling of your body, arms, and legs. If you miss a dose of Propylthio…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressant: A medicine that lowers the activity of the immune system.

lupus-like syndrome: A set of symptoms resembling lupus, such as joint pain, rash, and fever, that appears while taking a substance and usually settles after stopping it.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

edema: Swelling caused by extra fluid trapped in the body's tissues.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

in utero: Inside the womb, describing a baby before it is born.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

pruritus: Itching of the skin.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

TSH: Thyroid-stimulating hormone, a hormone measured by a blood test to check how well the thyroid gland is working.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Propylthiouracil NDCsSame ingredient 🏭 All Chartwell labeler NDCsLabeler code 62135 📚 All Thyroid Hormone Synthesis Inhibitor NDCsDrug class 📖 Read the Propylthiouracil drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antithyroid Preparations.

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Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.