PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

propylthiouracil

Verify with FDA → · CMS NADAC pricing →

Brand names: PTU

Anti-Thyroid Agent Rx

Propylthiouracil (PTU) is a medicine that treats an overactive thyroid. It helps to lower the amount of thyroid hormone your body makes.

Drug Pricing (NADAC)

Generic Price

$0.29/unit

Generic Available

Yes (4 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

PTU treats hyperthyroidism, which is when your thyroid gland makes too much thyroid hormone.

Common side effects

Skin rash, Hives, Nausea

Key warnings

PTU can cause severe liver problems, including liver failure, which can be fatal.

How It Works

PTU works by stopping your thyroid gland from making too much thyroid hormone. It does this by interfering with the process that creates these hormones. This helps to reduce the symptoms of hyperthyroidism.

How to Take It

Take PTU by mouth. The usual starting dose for adults is 300 mg per day, divided into 3 equal doses taken about 8 hours apart. Your doctor may increase this to 400 mg daily if you have severe hyperthyroidism or a very large goiter. The usual maintenance dose is 100 to 150 mg daily, but follow your doctor's specific instructions.

Pregnancy & Breastfeeding

PTU may be used during the first 3 months of pregnancy if an antithyroid drug is needed. Talk to your doctor about the risks and benefits of taking PTU while pregnant or breastfeeding.

Missed Dose

If you miss a dose of PTU, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store PTU tablets at room temperature, between 59° to 86°F (15° to 30°C).

Side Effects (from patient reports)

Based on 1,034 FDA adverse event reports.

The drug is not working
189
Using the drug for a condition it's not approved for
149
Overactive thyroid
135
Baby exposed to the drug during pregnancy
113
Feeling sick to your stomach
87
Exposure to the drug during pregnancy
84
Inflammation of blood vessels due to abnormal antibodies
83
Mother exposed to the drug during pregnancy
68
Low blood pressure
67
Low white blood cell count
59

FDA Adverse Event Report Analysis

Detailed analysis of 1,982 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

1,982

Death-Related Reports

170

Hospitalization Reports

907

Top Indication

Hyperthyroidism

Gender Distribution

Female 1,283 (73%)
Male 460 (26%)

Age Distribution

0–17 63
18–44 577
45–64 447
65–74 198
75+ 180

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 189
2 OFF LABEL USE 149
3 HYPERTHYROIDISM 135
4 FOETAL EXPOSURE DURING PREGNANCY 113
5 NAUSEA 87
6 EXPOSURE DURING PREGNANCY 84
7 ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS 83
8 MATERNAL EXPOSURE DURING PREGNANCY 68
9 HYPOTENSION 67
10 AGRANULOCYTOSIS 59
11 FATIGUE 58
12 PYREXIA 58
13 PRODUCT USE IN UNAPPROVED INDICATION 56
14 VOMITING 56
15 CARDIAC ARREST 54

Reactions in Death Reports

CARDIAC ARREST 23
DEATH 21
MULTIPLE ORGAN DYSFUNCTION SYNDROME 19
ACUTE KIDNEY INJURY 14
RENAL FAILURE 13
CARDIAC FAILURE CONGESTIVE 11
ACUTE HEPATIC FAILURE 10
PNEUMONIA 10
CIRCULATORY COLLAPSE 9
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 9

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 111
HYPERTHYROIDISM 82
OFF LABEL USE 60
HYPOTENSION 49
NAUSEA 45
AGRANULOCYTOSIS 42
PYREXIA 41
VOMITING 36
ACUTE KIDNEY INJURY 35
ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS 35

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

PTU can cause severe liver problems, including liver failure, which can be fatal. You should only use PTU if you cannot take methimazole and surgery or radioactive iodine are not right for you. PTU may be the best choice if you need an antithyroid drug during or just before the first 3 months of pregnancy.

Common Questions

What should I do if I experience nausea after taking PTU?
Try taking PTU with food to reduce nausea. If nausea persists, contact your doctor.
Can PTU affect my ability to drive or operate machinery?
PTU may cause drowsiness or dizziness in some people. If you experience these side effects, avoid driving or operating machinery.
How long does it take for PTU to start working?
It may take several weeks for PTU to fully control your hyperthyroidism symptoms. Continue taking the medication as prescribed and follow up with your doctor.
Are there any foods or drinks I should avoid while taking PTU?
There are no specific food or drink restrictions while taking PTU, but it's always a good idea to maintain a balanced diet.
What tests will my doctor do while I'm taking PTU?
Your doctor will regularly check your thyroid hormone levels (TSH and free T4) and may also monitor your liver function and white blood cell count.
Can I stop taking PTU once my thyroid levels are normal?
No, do not stop taking PTU without talking to your doctor first. They will determine when it is safe to stop the medication.
What are the symptoms of liver problems I should watch out for?
Symptoms of liver problems include yellowing of the skin or eyes, dark urine, pale stools, severe stomach pain, nausea, vomiting, and fatigue. Contact your doctor immediately if you experience any of these symptoms.
Can PTU cause hair loss?
Yes, PTU can cause hair loss in some people. This is usually temporary and hair growth should return after stopping the medication.
Is it safe to take other medications with PTU?
Tell your doctor about all the medications you are taking, including over-the-counter drugs and supplements, to avoid potential interactions.
What should I do if I think I'm having an allergic reaction to PTU?
If you experience symptoms of an allergic reaction, such as rash, itching, swelling, or difficulty breathing, seek immediate medical attention.
What are the common side effects of propylthiouracil?
The most commonly reported side effects of propylthiouracil include Skin rash, Hives, Nausea, Vomiting, Stomach upset. Based on 1,034 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is propylthiouracil?
propylthiouracil belongs to the Anti-Thyroid Agent drug class. It requires a prescription (Rx). PTU treats hyperthyroidism, which is when your thyroid gland makes too much thyroid hormone.
Is propylthiouracil safe during pregnancy?
PTU may be used during the first 3 months of pregnancy if an antithyroid drug is needed. Talk to your doctor about the risks and benefits of taking PTU while pregnant or breastfeeding. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Anti-Thyroid Agent

Other drugs grouped near propylthiouracil — same-class peers and common alternatives.

Compare propylthiouracil vs levothyroxine side-by-side →

Medication Guides

Related Health & Safety Data

Save on propylthiouracil

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for propylthiouracil

The FDA label for propylthiouracil (sold under brand names such as PTU) classifies it as a prescription-only medication in the Anti-Thyroid Agent class. PTU treats hyperthyroidism, which is when your thyroid gland makes too much thyroid hormone. Official labeling lists 18 commonly reported side effects, including Skin rash, Hives, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,034 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.29.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 26, 2023

All federal data sources used on this page