Ritemed Celecoxib Adverse Reactions

Adverse reactions are listed by system organ class and ranked by frequency in the list as follows, reflecting data from the following sources: Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators, approximately 7,400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2,300 patients treated for 1 year or longer. The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed as follows.
Adverse reactions reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg daily in long-term polyp prevention trials of duration up to 3 years (the Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials; see Pharmacology: Pharmacodynamic properties: Cardiovascular safety-long-term studies involving patients with sporadic adenomatous polyps under Actions).
Adverse reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications). Even though these were identified as reactions from post marketing reports, trial data were consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis with pooling of trials representing exposure in 38,102 patients.
Adverse reactions in celecoxib clinical trials and surveillance experience (MedDRA preferred terms)^1,2: 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); Not known (cannot be estimated from the available data).
Infections and infestations: Common: Sinusitis, upper respiratory tract infection, urinary tract infection.
Blood and lymphatic system disorders: Uncommon: Anaemia. Rare: Leucopenia, thrombocytopenia. Very rare: Pancytopenia⁴.
Immune system disorders: Common: Hypersensitivity. Very rare: Anaphylactic shock⁴, anaphylactic reaction⁴.
Metabolism and nutrition disorders: Uncommon: Hyperkalaemia.
Psychiatric disorders: Common: Insomnia. Uncommon: Anxiety, depression, fatigue. Rare: Confusional state, hallucinations⁴.
Nervous system disorders: Common: Dizziness, hypertonia, headache⁴. Uncommon: Cerebral infarction¹, paraesthesia, somnolence. Rare: Ataxia, dysgeusia. Very rare: Haemorrhage intracranial (including fatal intracranial haemorrhage)⁴, meningitis aseptic⁴, epilepsy (including aggravated epilepsy)⁴, ageusia⁴, anosmia⁴.
Eye disorders: Uncommon: Vision blurred, conjunctivitis⁴. Rare: Eye haemorrhage⁴. Very rare: Retinal artery occlusion⁴, retinal vein occlusion⁴.
Ear and labyrinth disorders: Uncommon: Tinnitus, hypoacusis¹.
Cardiac disorders: Common: Myocardial infarction¹. Uncommon: Cardiac failure, palpitations, tachycardia. Rare: Arrhythmia⁴.
Vascular disorders: Very Common: Hypertension¹ (including aggravated hypertension). Rare: Pulmonary embolism⁴, flushing⁴. Very rare: Vasculitis⁴.
Respiratory, thoracic and mediastinal disorders: Common: Rhinitis, cough, dyspnoea¹. Uncommon: Bronchospasm⁴. Rare: Pneumonitis⁴.
Gastrointestinal disorders: Common: Nausea⁴, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting¹, dysphagia¹. Uncommon: Constipation, gastritis, stomatitis, gastrointestinal inflammation (including aggravation of gastrointestinal inflammation), eructation. Rare: Gastrointestinal haemorrhage⁴, duodenal ulcer, gastric ulcer, oesophageal ulcer, intestinal ulcer, large intestinal ulcer, intestinal perforation, oesophagitis, melaena, pancreatitis, colitis⁴.
Hepatobiliary disorders: Uncommon: Hepatic function abnormal, hepatic enzyme increased (including increased SGOT and SGPT). Rare: Hepatitis⁴. Very rare: Hepatic failure⁴ (sometimes fatal or requiring liver transplant), hepatitis fulminant⁴ (some with fatal outcome), hepatic necrosis⁴, cholestasis⁴, hepatitis, cholestatic⁴, jaundice⁴.
Skin and subcutaneous tissue disorders: Common: Rash, pruritus (includes pruritus generalised). Uncommon: Urticaria, ecchymosis⁴. Rare: Angioedema⁴, alopecia, photosensitivity. Very rare: Dermatitis exfoliative⁴, erythema multiforme⁴, Stevens-Johnson syndrome⁴, toxic epidermal necrolysis⁴, drug reaction with eosinophilia and systemic symptoms (DRESS)⁴, acute generalised exanthematous pustulosis (AGEP)⁴, dermatitis bullous⁴.
Musculoskeletal and connective tissue disorders: Common: Arthalgia⁴. Uncommon: Muscle spasms (leg cramps). Very rare: Myositis⁴.
Renal and urinary disorders: Uncommon: Blood creatinine increased, blood urea increased. Rare: Renal failure acute⁴, hyponatraemia⁴. Very rare: Tubulointerstitial nephritis⁴, nephrotic syndrome⁴, glomerulonephritis minimal lesion⁴.
Reproductive system and breast disorders: Rare: Menstrual disorder⁴. Not known: Infertility female (female fertility decreased)³.
General disorders and administration side conditions: Common: Influenza-like, illness, oedema peripheral/fluid retention. Uncommon: Face oedema, chest pain⁴.
Injury, poisoning and procedural complications: Common: Injury (accidental injury).
¹ Adverse reactions that occurred in polyp prevention trials, representing subjects treated with celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the APC and PreSAP trials). The adverse reactions listed previously for the polyp prevention trials are only those that have been previously recognised in the post-marketing surveillance experience, or have occurred more frequently than in the arthritis trials.
² Furthermore, the following previously unknown adverse reactions occurred in polyp prevention trials, representing subjects treated with celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the APC and PreSAP trials): Common: angina pectoris, irritable bowel syndrome, nephrolithiasis, blood creatinine increased, benign prostatic hyperplasia, weight increased. Uncommon: helicobacter infection, herpes zoster, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival haemorrhage, deep vein thrombosis, dysphonia, haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, allergic dermatitis, ganglion, nocturia, vaginal haemorrhage, breast tenderness, lower limb fracture, blood sodium increased.
³ 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.
⁴ Frequencies are based on cumulative meta-analysis with pooling of trials representing exposure in 38,102 patients.
In final data (adjudicated) from the APC and PreSAP trials in patients treated with celecoxib 400 mg daily for up to 3 years (pooled data from both trials; see Pharmacology: Pharmacodynamics under Actions for results from individual trials), the excess rate over placebo for myocardial infarction was 7.6 events per 1,000 patients (uncommon) and there was no excess rate for stroke (types not differentiated over placebo.