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What the label lists and what reports show

Praziquantel side effects

Praziquantel's FDA label lists its adverse reactions in its own words. FAERS holds 301 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (22 reports).

  • Generic listed

Check it at the source: the praziquantel FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Clinical Deterioration [see Warnings and Precautions ( 5.1 )] • Central Nervous System (CNS) Effects [see Warnings and Precautions ( 5.2 )] • Potential Lack of Efficacy During the Acute Phase of Schistosomiasis [see Warnings and Precautions ( 5.3 )] • Cardiac Arrhythmias [see Warnings and Precautions ( 5.4 )] • Hepatic Impairment in Hepatosplenic Schistosomiasis Patients [see Warnings and Precautions ( 5.5 )] • Concomitant Administration with Strong Cytochrome P450 Inducers [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of Biltricide were identified in clinical studies, published literature or postmarketing reports. …

Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9), via openFDA; the full label on DailyMed

What do FAERS reports show?

301 reports list praziquantel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 105 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)41
  • Off Label Use (a use or a product term, not a reaction)35
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)22
  • Pyrexia (named in the label)22
  • Condition Aggravated (a use or a product term, not a reaction)16
  • Headache (named in the label)15
  • Vomiting (named in the label)15
  • Eosinophilia (named in the label)13
  • Seizure13
  • Dizziness (named in the label)12
  • Product Prescribing Issue (a use or a product term, not a reaction)12
  • Schistosomiasis (a use or a product term, not a reaction)11
  • Urticaria (named in the label)10
  • Abdominal Pain (named in the label)9
  • Diarrhoea (named in the label)9
  • Nausea (named in the label)9
  • Osteonecrosis9
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)8
  • Malaise (named in the label)8
  • Pancytopenia8
  • Abdominal Pain Upper7
  • Acute Kidney Injury7
  • Asthenia (named in the label)7
  • Cough7
  • Death (an outcome recorded in the report)7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Praziquantel: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions