Drug Safety Information for PROPYLTHIOURACIL (Propylthiouracil)

Safety-related Labeling Changes for PROPYLTHIOURACIL (PROPYLTHIOURACIL) Rx Drug: FDA Link

Adverse Drug Reactions for PROPYLTHIOURACIL* (Propylthiouracil)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PROPYLTHIOURACIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hyperthyroidism53
2Nausea50
3Pyrexia44
4Vomiting39
5Agranulocytosis36
6Dyspnoea32
7Anaemia31
8Pneumonia30
9Diarrhoea29
10Asthenia28
11Arthralgia*27
12Tachycardia25
13Weight decreased24
14Sepsis24
15Hypotension24
16Abdominal pain23
17Antineutrophil cytoplasmic antibody positive23
18Maternal drugs affecting foetus23
19Cardio-respiratory arrest23
20Dizziness23

* This side effect also appears in "Top 10 Side Effects of PROPYLTHIOURACIL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PROPYLTHIOURACIL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hyperthyroidism*971
2Basedow's disease719
3Product used for unknown indication191
4Hypothyroidism112
5Thyrotoxic crisis49
6Thyroid disorder47
7Maternal exposure during pregnancy28
8Tachycardia foetal19
9Toxic nodular goitre19
10Hypertension13

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PROPYLTHIOURACIL

Total Reports Filed with FDA: 4107


Number of FDA Adverse Event Reports by Patient Age for PROPYLTHIOURACIL

Total Reports Filed with FDA: 4107*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Propylthiouracil (Propylthiouracil)

Charts are based on 4107 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PROPYLTHIOURACIL Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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