Cubicin Adverse Reactions

Undesirable Effects Identified during Clinical Trials: During clinical trials of CUBICIN, the following adverse drug reactions were reported during therapy and during follow-up. The adverse drug reactions are organized by system organ class, and the frequency categories for these adverse drug reactions are reported in the table as follows: Very common: ≥1/10 (≥10%), Common: ≥1/100 and <1/10 (≥1% and <10%), Uncommon: ≥1/1000 and <1/100 (≥0.1% and <1%), Rare: ≥1/10,000 and <1/1000 (≥0.01% and <0.1%), Very rare: <1/10,000 (<0.01%). (See Table 7.)

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Undesirable Effects Reported Post-Marketing: The following adverse drug reactions, not listed previously, have been reported during worldwide post-marketing experience: Blood and lymphatic system disorders: Thrombocytopenia.
Immune system disorders: Hypersensitivity reactions, including, but not limited to, anaphylaxis, angioedema and pulmonary eosinophilia.
Infections and infestations: Clostridiodes difficile-associated diarrhea.
Investigations: Myoglobin increased, platelet count decreased.
Musculoskeletal, connective tissue, and bone disorders: Rhabdomyolysis.
Nervous system disorders: Peripheral neuropathy.
Renal and urinary disorders: Tubulointerstitial nephritis (TIN).
Respiratory, thoracic, and mediastinal disorders: Cough, Eosinophilic pneumonia, Organizing pneumonia.
Skin and subcutaneous tissue disorders: Vesiculobullous rash with or without mucous membrane involvement (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), Drug reaction with eosinophilia and systemic symptoms (DRESS), Acute generalized exanthematous pustulosis.