Lexib Adverse Reactions

Clinical Trials Experience: The following adverse drug reactions (ADRs) in Table 1 were identified with incidence rates greater than 0.01% in celecoxib group and greater than those reported in placebo group, during 12 placebo- and/or active-controlled clinical trials of treatment duration up to 12 weeks at daily doses from 100 mg up to 800 mg in adults.
The frequencies on the ADRs in Table 1 are updated based on a more recent pooling of 89 randomized, controlled clinical trial data representing clinical exposure in 38,102 patients taking celecoxib. ADR frequencies are defined as: very common (≥10%), common (≥1% and <10%), uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%), very rare (<0.01%). The ADRs in Table 1 are listed by system organ class and ranked by frequency in descending order. (See Table 1.)

Click on icon to see table/diagram/image

The following additional adverse drug reactions in Table 2 were identified with incidence rates greater than placebo in long-term polyp prevention studies of duration up to 3 years at daily doses from 400 mg up to 800 mg.
Frequencies of ADRs in Table 2 were determined based on these long-term polyp prevention studies and defined as: very common (≥10%), common (≥1% and <10%), uncommon (≥0.1% and <1%). The ADRs in Table 2 are listed by system organ class and ranked by frequency in descending order. (See Table 2.)

Click on icon to see table/diagram/image

Post-marketing Experience: Adverse reactions identified from post-marketing experience are provided as follows. Even though these were identified as reactions from post-marketing reports, trial data was consulted to estimate frequency. As previously mentioned, frequencies are based on a pooling of trials representing exposure in 38,102 patients. Frequencies are defined as: very common (≥10%), common (≥1% and <10%), uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%), very rare (<0.01%), not known (cannot be estimated from the available data): Immune system disorders: Very rare: anaphylactic reaction.
Psychiatric disorders: Rare: hallucination.
Nervous system disorders: Very rare: cerebral haemorrhage, meningitis aseptic, ageusia, anosmia.
Eye disorders: Uncommon: conjunctivitis.
Vascular disorders: Very rare: vasculitis.
Respiratory, thoracic and mediastinal disorders: Rare: pulmonary embolism, pneumonitis.
Gastrointestinal disorders: Rare: gastrointestinal haemorrhage.
Hepatobiliary disorders: Rare: hepatitis. Very rare: hepatic failure, hepatitis fulminant, hepatic necrosis, cholestasis, hepatitis cholestatic, jaundice.
Skin and subcutaneous tissue disorders: Rare: photosensitivity reaction. Very rare: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), dermatitis exfoliative.
Renal and urinary disorders: Rare: renal failure acute, hyponatremia. Very rare: tubulointerstitial nephritis, nephrotic syndrome, glomerulonephritis minimal lesion.
Reproductive system and breast disorders: Rare: menstrual disorder. Not known: infertility female (female fertility decreased).
General disorders and administration site conditions: Uncommon: chest pain.