Drug Safety Information for BILTRICIDE (Praziquantel)

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

Adverse Drug Reactions for BILTRICIDE* (Praziquantel)

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 BILTRICIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia16
2Drug ineffective10
3Schistosomiasis8
4Vomiting8
5Eosinophilia8
6Urticaria8
7Myalgia6
8Angioedema5
9Hepatitis b dna assay positive5
10Abdominal pain5
11Dizziness5
12Liver disorder5
13Death4
14Red blood cell schistocytes present4
15Headache4
16Hepatic neoplasm malignant recurrent3
17Fatigue3
18Hyperhidrosis3
19Mazzotti reaction3
20General physical health deterioration3

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

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

Reason # of FDA Reports
1Schistosomiasis106
2Helminthic infection47
3Product used for unknown indication34
4Neurocysticercosis21
5Fascioliasis19
6Cestode infection19
7Opisthorchiasis12
8Infection parasitic12
9Parasitic gastroenteritis11
10Clonorchiasis8

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


Types of Adverse Events for BILTRICIDE

Total Reports Filed with FDA: 375


Number of FDA Adverse Event Reports by Patient Age for BILTRICIDE

Total Reports Filed with FDA: 375*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Praziquantel (Cisticid, Biltricide)

Charts are based on 375 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 BILTRICIDE Reviews and Review Summary .

Historical 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.