Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 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 praziquantel were identified in clinical studies, published literature or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions were observed in both adults and pediatric patients: General disorders and administration site conditions: malaise, pyrexia Nervous system disorders: headache, dizziness Gastrointestinal disorders: abdominal discomfort, nausea Skin and subcutaneous tissue disorders: urticaria Such adverse reactions may be more frequent and/or serious in patients with a heavy worm burden.
Additional adverse reactions reported from worldwide post marketing experience and from publications with praziquantel and various formulations of praziquantel include: Blood and lymphatic system disorders: eosinophilia Cardiac disorders: arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks) Ear and labyrinth disorders: vertigo, tinnitus Eye disorders: visual disturbance Gastrointestinal disorders: abdominal pain, bloody diarrhea, vomiting General disorders and administration site conditions: polyserositis, asthenia, fatigue, gait disturbance Hepatobiliary disorders: hepatitis Immune system disorders: allergic reaction, generalized hypersensitivity, anaphylactic reaction Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: convulsion, somnolence, intention tremor Respiratory, thoracic and mediastinal disorders: pneumonitis, dyspnea, wheezing Skin and subcutaneous tissue disorders: pruritus, rash, Stevens-Johnson syndrome Pediatric patients 1 to 17 years of age treated with praziquantel tablets and various formulations of praziquantel experienced similar adverse reactions as those observed in adult patients.
The adverse reactions reported were malaise, headache, dizziness, abdominal discomfort (with or without nausea), pyrexia and urticaria.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Clinical Deterioration : Potentially life threatening clinical deterioration can occur in patients treated during the acute phase of schistosomiasis.
( 5.1 ) Central Nervous System (CNS) Effects : Praziquantel can exacerbate central nervous system pathology due to schistosomiasis.
Consider whether to administer to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis.
( 5.2 ) Potential Lack of Efficacy for Acute Schistosomiasis : This has been reported in observational studies ( 5.3 ).
Cardiac Arrhythmias: Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with praziquantel administration.
Like all medications, Praziquantel can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: