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Propylthiouracil

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Black, tarry stools
  • Chest pain
  • Chills
  • Cough
  • Fever
  • Painful or difficult urination
  • Shortness of breath
  • Sore throat
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Swollen glands
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness

Less common

  • Dark-colored urine
  • General feeling of discomfort, illness, or weakness
  • Headache
  • Light-colored stools
  • Nausea or vomiting
  • Stomach pain, continuing
  • Upper right abdominal or stomach pain
  • Yellow eyes and skin

Incidence not known

  • Abdominal or stomach pain
  • Agitation
  • Bleeding gums
  • Bleeding under the skin
  • Blood in the urine or stools
  • Bloody or cloudy urine
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Coma
  • Confusion
  • Cough or hoarseness
  • Cracks in the skin
  • Decreased urine output
  • Depression
  • Difficulty with breathing
  • Difficulty with moving
  • Dizziness
  • Drowsiness
  • Feeling of fullness
  • Fever with or without chills
  • General feeling of discomfort, illness, or weakness
  • High blood pressure
  • Hostility
  • Irritability
  • Joint pain
  • Lethargy
  • Loss of appetite and weight
  • Loss of heat from the body
  • Lower back or side pain
  • Muscle aching or cramping
  • Muscle pain or stiffness
  • Muscle twitching
  • Numbness or tingling of the hands, feet, or face
  • Pain in the ankles or knees
  • Painful, red lumps under the skin, mostly on the legs
  • Pinpoint red spots on the skin
  • Rapid weight gain
  • Red, swollen skin
  • Redness, soreness, or itching skin
  • Scaly skin
  • Seizures
  • Soreness of the muscles
  • Sores on the skin
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Sores, welting, or blisters
  • Stupor
  • Swelling of the face, ankles, hands, feet, or lower legs
  • Swollen joints
  • Swollen salivary glands
  • Swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • Tightness in the chest
  • Unusual weight gain
  • Wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Bloody, black, or tarry stools
  • High fever
  • Itching skin
  • Pale skin
  • Swelling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Abnormal loss of hair
  • Change in taste or bad unusual or unpleasant (after) taste
  • Dizziness or lightheadedness
  • Feeling of constant movement of self or surroundings
  • Heartburn
  • Hives or welts
  • Loss of taste
  • Pain or discomfort in the chest, upper stomach, or throat
  • Sensation of spinning
  • Skin rash
  • Sleepiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of hyperthyroidism (overactive thyroid):
      • Adults—At first, 300 to 900 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is usually 100 to 150 mg daily.
      • Children 6 years of age and older—At first, 50 mg daily, divided into 3 equal doses and given every 8 hours. Your doctor may adjust your dose as needed.
      • Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of reports of severe liver problems, propylthiouracil is not recommended in pediatric patients except in instances where other medicines (e.g., methimazole), surgery, or radioactive iodine therapy have not worked well

Geriatric

No information is available on the relationship of age to the effects of propylthiouracil in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Anisindione
  • Dicumarol
  • Phenindione
  • Phenprocoumon
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia) or
  • Liver disease—Use with caution. May make these conditions worse.