Peldacyn Adverse Reactions

Capsule: The list as follows shows the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 4.)

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Solution for Injection: Local Reactions: Pain, insensibility and sterile abscess have been reported after IM injection and thrombophlebitis after IV injection. Reactions can be minimized or avoided by giving deep IM injections and avoiding prolonged use of indwelling IV catheters.
Gastrointestinal: Pseudomembranous colitis, diarrhea, nausea, vomiting, anorexia, glossitis, stomatitis, abdominal pain and esophagitis may occur.
Shock: Patients should be closely observed during therapy because shock may occur infrequently. Medication should be discontinued when cyanosis, dyspnea, shortness of breath, hypotension occurs.
Hypersensitivity: Maculopapular rash, urticaria and edema may occur during therapy. If hypersensitivity reaction occurs, the drug should be discontinued and in serious cases, the usual emergency treatment agents (epinephrine, corticosteroids, antihistamines) should be available.
Skin: Patients should be closely observed since Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, erythema multiforme may occur and medication should be discontinued when these occur.
Liver: Jaundice and increase in serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) may occur.
Kidney: Renal dysfunction as azotomia, oliguria, proteinuria has been observed.
Musculoskeletal: Instances of polyarthritis have been rarely been reported.
Cardiovascular: Rare instances of cardiopulmonary arrest and hypotension have been reported following too rapid IV administration.
Hematopoietic: Neutropenia, leukopenia, agranulocytosis, thrombocytopenic purpura, aplastic anemia may occur.
Nervous System: Tinnitus, dizziness may occur during drug therapy.
Others: Facial flush, bitter taste, fever, headache, fatigue may occur.
Inform physician of any adverse effect suffered from using Peldacyn.