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 clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity and Dermatologic Reactions [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Hepatic Toxicity [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥ 10%) in Pediatric patients: Digestive (nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc.
at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 2 presents the adverse reactions associated with Chemet in pediatric patients.
Table 2 Incidence of Adverse Reactions Associated with Chemet in Pediatric Patients Body System: Adverse Reactions Pediatric Patients (n=191) Digestive Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth 12% Body as a Whole Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis.
5% Metabolic Elevated ALT or AST, alkaline phosphatase, serum cholesterol.
4% Respiratory Sore throat, rhinorrhea, nasal congestion, cough.
4% Skin Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritis.
3% Nervous Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia.
5 WARNINGS AND PRECAUTIONS Hypersensitivity and dermatologic reactions: Interrupt treatment if rash or mucocutaneous vesicular eruptions occur.
( 5.1 ) Neutropenia: Monitor complete blood counts, interrupt treatment for ANC below 1200/mcL, and monitor for infection.
( 5.2 ) Hepatic Toxicity: Monitor hepatic transaminases (ALT/AST);
interrupt treatment if above 5 times ULN.
( 5.3 ) Embryo-Fetal Toxicity: May cause fetal harm when administered to a pregnant woman.
Like all medications, Chemet 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: