Feldene (Piroxicam) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

In patients taking FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:

•   Cardiovascular System: Edema.
•   Digestive System: Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.
•   Hemic and Lymphatic System: Anemia, increased bleeding time.
•   Nervous System: Dizziness, headache.
•   Skin and Appendages: Pruritus, rash.
•   Special Senses: Tinnitus.
•   Urogenital System: Abnormal renal function.

Additional adverse experiences reported occasionally include:

•   Body As a Whole: Fever, infection, sepsis.
•   Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope.
•   Digestive System: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.
•   Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia.
•   Metabolic and Nutritional: Weight changes.
•   Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.
•   Respiratory System: Asthma, dyspnea.
•   Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat.
•   Special Senses: Blurred vision.
•   Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure.

Other adverse reactions which occur rarely are:

•   Body As a Whole: Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness.
•   Cardiovascular System: Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis.
•   Digestive System: Eructation, liver failure, pancreatitis.
•   Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.
•   Hypersensitivity: Positive ANA.
•   Metabolic and Nutritional: Hyperglycemia, hypoglycemia.
•   Nervous System: Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations.
•   Respiratory: Respiratory depression, pneumonia.
•   Skin and Appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson syndrome, urticaria, vesiculobullous reaction.
•   Special Senses: Conjunctivitis, hearing impairment, swollen eyes.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FELDENE

Possible Feldene side effects / adverse reactions in 41 year old male

Reported by a individual with unspecified qualification from United States on 2007-03-12

Patient: 41 year old male

Reactions: Blood Pressure Increased, Medication Error, Chest Pain, Wrong Drug Administered, Drug Dispensing Error

Suspect drug(s):
Feldene
    Dosage: capsule

Felodipine
    Dosage: tablet, extended release

Possible Feldene side effects / adverse reactions in 15 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-03-16

Patient: 15 year old male weighing 57.0 kg (125.4 pounds)

Reactions: Duodenal Ulcer Perforation, Peritonitis

Adverse event resulted in: life threatening event

Suspect drug(s):
Feldene
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2007-02-07
    End date: 2007-02-14

Domperidone
    Indication: Abdominal Pain
    Start date: 2007-02-07
    End date: 2007-02-14

Spasfon
    Dosage: text:3 df
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2007-02-07
    End date: 2007-02-14

Possible Feldene side effects / adverse reactions in 62 year old female

Reported by a physician from Spain on 2007-04-02

Patient: 62 year old female

Reactions: Diarrhoea, Oesophageal Disorder, Gastrointestinal Disorder, Deafness, Toxic Epidermal Necrolysis, Tracheal Ulcer, Blindness

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Feldene
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2005-06-19
    End date: 2005-06-24

Feldene
    Indication: Inflammation

Feldene
    Indication: Osteoarthritis

Other drugs received by patient: Xicil; Acetaminophen; Omeprazole

Possible Feldene side effects / adverse reactions in 89 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-04-09

Patient: 89 year old female

Reactions: Confusional State, Hyponatraemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Feldene
    Administration route: Oral
    Indication: Myalgia
    Start date: 2007-02-08
    End date: 2007-02-18

Venlafaxine HCL
    Administration route: Oral
    Start date: 2007-02-24
    End date: 2007-02-25

Other drugs received by patient: Bromazepam; Zolpidem Tartrate; Trimetazidine Dihydrochloride; Budesonide; Salmeterol Xinafoate; Hexaquine; Relvene; Ethinyl Estradiol TAB; Fenofibrate; Trimebutine Maleate

Possible Feldene side effects / adverse reactions in 77 year old female

Reported by a individual with unspecified qualification on 2007-04-30

Patient: 77 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Seguril /00032601/
    Start date: 2006-01-01

Omeprazole
    Start date: 2007-01-01

Cefuroxime Axetil
    Start date: 2007-01-01

Nsaid's
    Start date: 2006-01-01

Feldene
    Start date: 2006-01-01

Manidon
    Start date: 2006-01-01

Adiro
    Start date: 2006-01-01

Fosamax
    Start date: 2006-01-01

Deanxit /00428501/
    Start date: 2006-01-01

Other drugs received by patient: Spiriva; Pulmicort; Nylidrin; Iron

Possible Feldene side effects / adverse reactions in 77 year old female

Reported by a consumer/non-health professional from Spain on 2007-04-30

Patient: 77 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Cefuroxime
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-01-01

Omeprazole
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-01-01

Seguril
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

NON Steroidal Anti-Inflammatory
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Feldene
    Indication: Drug USE FOR Unknown Indication

Manidon
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Adiro
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Fosamax
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Deanxit
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Other drugs received by patient: Spiriva; Pulmicort; Flumil; FE

Possible Feldene side effects / adverse reactions in 77 year old female

Reported by a pharmacist from Spain on 2007-05-01

Patient: 77 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Feldene
    Administration route: Oral
    Start date: 2006-01-01

Cefuroxime
    Administration route: Oral
    Start date: 2007-01-01

Omeprazole
    Start date: 2007-01-01

Furosemide
    Administration route: Oral
    Start date: 2006-01-01

Nsaid's
    Start date: 2006-01-01

Verapamil
    Administration route: Oral
    Start date: 2006-01-01

Adiro
    Administration route: Oral
    Start date: 2006-01-01

Fosamax
    Administration route: Oral

Deanxit
    Dosage: text:10/0.5 mg
    Administration route: Oral

Other drugs received by patient: Spiriva; Pulmicort; Acetylcysteine; Iron

Possible Feldene side effects / adverse reactions in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2007-05-01

Patient: 77 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Adiro
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Zinnat 125 MG
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-01-01

Omeprazole
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-01-01

Seguril
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Nsaid
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Feldene
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Manidon
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Fosamax
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Deanxit 10/0.5 MG (Flupentixol)
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-01

Spiriva
    Indication: Drug USE FOR Unknown Indication

Pulmicort
    Indication: Drug USE FOR Unknown Indication

Flumil
    Indication: Drug USE FOR Unknown Indication

Ferrum
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Possible Feldene side effects / adverse reactions in 40 year old female

Reported by a physician from Morocco on 2007-05-16

Patient: 40 year old female

Reactions: Asthma, Anaphylactic Shock

Suspect drug(s):
Feldene

Possible Feldene side effects / adverse reactions in 14 year old male

Reported by a physician from Belgium on 2007-05-22

Patient: 14 year old male

Reactions: Vomiting, Tongue Discolouration, Chromaturia, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Feldene

Uropyrine

Benzodiazepine Derivatives

Other drugs received by patient: Desloratadine

Possible Feldene side effects / adverse reactions in 14 year old male

Reported by a physician from Belgium on 2007-06-01

Patient: 14 year old male weighing 55.0 kg (121.0 pounds)

Reactions: Blood Bilirubin Increased, Vomiting, Overdose, Tongue Discolouration, Chromaturia, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Feldene
    Dosage: text:20-460 mg. tdd

Uropyrine

Benzodiazepine Derivatives

Other drugs received by patient: Desloratadine

Possible Feldene side effects / adverse reactions in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-06

Patient: 65 year old female

Reactions: Gastrointestinal Haemorrhage, Gastritis

Suspect drug(s):
Feldene

Possible Feldene side effects / adverse reactions in 73 year old female

Reported by a individual with unspecified qualification from France on 2007-06-25

Patient: 73 year old female weighing 111.0 kg (244.2 pounds)

Reactions: Blood PH Increased, Rales, PO2 Decreased, Haematocrit Decreased, RED Blood Cell Count Decreased, Interstitial Lung Disease, Cyanosis, Pulmonary Oedema, Hypoxia, Knee Arthroplasty, Oxygen Supplementation, Oxygen Saturation Decreased, White Blood Cell Count Increased, Eosinophilia, Haemoglobin Decreased, Postoperative Respiratory Distress, Bronchoalveolar Lavage

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren
    Dosage: unk, prn
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 1999-12-01
    End date: 2006-08-01

Feldene
    Dosage: unk, prn (total of 1 pack)
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2005-12-01
    End date: 2005-12-01

Feldene
    Dosage: unk, prn (total of 1 pack)
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Feldene
    Dosage: 1 df, prn (total of 1 pack)
    Administration route: Oral
    Start date: 2005-03-01
    End date: 2005-03-01

Possible Feldene side effects / adverse reactions in 18 year old female

Reported by a physician from France on 2007-06-27

Patient: 18 year old female

Reactions: Cough

Suspect drug(s):
Feldene

Possible Feldene side effects / adverse reactions in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-07-05

Patient: 73 year old female weighing 111.0 kg (244.2 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Feldene
    Dosage: text:1 df-freq:as needed
    Administration route: Oral
    Indication: Arthritis

Diclofenac
    Dosage: text:1 df-freq:as needed
    Administration route: Oral
    Indication: Arthritis
    Start date: 1999-12-01
    End date: 2006-08-01

Possible Feldene side effects / adverse reactions in 19 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-07-09

Patient: 19 year old female

Reactions: Rash Maculo-Papular

Adverse event resulted in: hospitalization

Suspect drug(s):
Ibuprofen
    Administration route: Oral
    Indication: Pharyngolaryngeal Pain

Paracetamol

Paracetamol
    Indication: Pharyngolaryngeal Pain

Feldene
    Administration route: Oral
    Indication: Pharyngolaryngeal Pain

Amoxicillin Trihydrate
    Administration route: Oral
    Indication: Pharyngolaryngeal Pain

Tetrazepam
    Administration route: Oral
    Indication: Pharyngolaryngeal Pain

Other drugs received by patient: Magne B6; Stresam; Tanganil; Euphytose

Possible Feldene side effects / adverse reactions in 45 year old male

Reported by a pharmacist from Spain on 2007-07-30

Patient: 45 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Hypersensitivity, Toxic Epidermal Necrolysis, Drug Rash With Eosinophilia and Systemic Symptoms, Staphylococcal Sepsis, Eosinophilia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Salazopyrina
    Administration route: Oral
    Indication: Arthropathy
    Start date: 2006-11-22
    End date: 2006-12-24

Feldene
    Administration route: Oral
    Indication: Arthropathy
    Start date: 2006-11-22
    End date: 2006-12-24

Possible Feldene side effects / adverse reactions in 97 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-10

Patient: 97 year old male weighing 81.6 kg (179.6 pounds)

Reactions: Blood Urea Increased, Peptic Ulcer Haemorrhage, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Suspect drug(s):
Feldene