ADVERSE REACTIONS
The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS (SEE WARNINGS SECTION).
Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.
Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.
Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.
Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.
Metabolic and Nutritional: Hyperkalemia (see PRECAUTIONS: Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS).
Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.
Psychiatric: Hallucinations, depression, apathy, nervousness.
Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with BACTRIM, mainly in AIDS patients.
Respiratory: Cough, shortness of breath and pulmonary infiltrates (see WARNINGS).
Miscellaneous: Weakness, fatigue, insomnia.
|
REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO BACTRIM DS
Below is a sample of reports where side effects / adverse reactions may be related to Bactrim DS. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Bactrim DS side effects / adverse reactions in 42 year old male
Reported by a pharmacist from United States on 2007-01-10
Patient: 42 year old male
Reactions: Nausea, Stevens-Johnson Syndrome
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Bactrim DS
Possible Bactrim DS side effects / adverse reactions in 58 year old male
Reported by a pharmacist from United States on 2007-01-23
Patient: 58 year old male weighing 83.9 kg (184.6 pounds)
Reactions: Angioedema
Adverse event resulted in: hospitalization
Suspect drug(s):
Bactrim DS
Possible Bactrim DS side effects / adverse reactions in 47 year old female
Reported by a physician from United States on 2007-02-05
Patient: 47 year old female weighing 68.7 kg (151.1 pounds)
Reactions: Glioblastoma Multiforme, Anorectal Cellulitis, Haemorrhoids, Malignant Neoplasm Progression, Bone Marrow Failure, Aplastic Anaemia, Febrile Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Temodar
Dosage: 75 mg/m2; qd; po
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2006-08-29
End date: 2006-09-25
Radiation Therapy
Dosage: qd;
Indication: Glioblastoma Multiforme
Start date: 2006-08-29
End date: 2006-10-03
Bactrim DS
Dosage: 1 df; tiw; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
End date: 2006-10-20
Dexamethasone
Indication: Drug USE FOR Unknown Indication
End date: 2006-10-01
Other drugs received by patient: Keppra; Prempro; Zofran; Rutovit C; Lycopene; Coq10; Shark-Liver OIL; Arnica Montana; Hamamelis Virginiana; Calcium Phosphate; Omega 3 Fish OIL; Ferrous Phosphate; M.v.i.; Ascorbic Acid; Vitamin D; Vitamin E; Vitamin B-12; Beta-Carotene Gisand /00540801/; Flaxseed OIL
|
