Celebrex Adverse Reactions

Clinical Trials Experience: The following adverse drug reactions (ADRs) in Table 10 were identified with incidence rates greater than 0.01% in celecoxib group and greater than those reported in placebo group, during 12 placeboand/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 10 are updated based on a more recent pooling of 89 randomized, controlled clinical trials 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 10 are listed by system organ class and ranked by frequency in descending order. (See Table 10.)

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The following additional adverse drug reactions* in Table 11 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 (see Pharmacology: Pharmacodynamics: Cardiovascular Safety: Long-term Studies Involving Patients With Sporadic Adenomatous Polyps under Actions).
Frequencies of ADRs in Table 11 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 11 are listed by system organ class and ranked by frequency in descending order. (See Table 11.)

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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 (see Hepatic Effects under Precautions), 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 (see Renal Effects under Precautions), 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) (see Fertility, pregnancy and lactation under Use in Pregnancy & Lactation)^†.
General disorders and administration site conditions: Uncommon: chest pain.
^†Women intending to become pregnant are excluded from all trials, thus consultation of the trial database for the frequency of this event was not reasonable.