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.
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REPORTS OF SUSPECTED BACTRIM DS SIDE EFFECTS / ADVERSE REACTIONS
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 considered as verified clinical evidence.
Possible Bactrim DS side effects / adverse reactions in 30 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-07
Patient: 30 year old male
Reactions: Skin Lesion, Purpura, Rash Maculo-Papular, Rash Pruritic
Adverse event resulted in: hospitalization
Suspect drug(s):
Pantoprazole
Dosage: 20.0 mg, 1x/day
Administration route: Oral
Indication: Colitis
Start date: 2005-03-26
End date: 2005-04-01
Pantoprazole
Indication: Gastrointestinal Inflammation
Bactrim DS
Dosage: 1 time(s) per day 2 df
Administration route: Oral
Indication: Colitis
Start date: 2005-03-26
End date: 2005-04-01
Transacalm
Indication: Gastrointestinal Inflammation
Bactrim DS
Indication: Gastrointestinal Inflammation
Transacalm
Dosage: 200.0 mg, 3x/day
Administration route: Oral
Indication: Colitis
Start date: 2005-03-26
End date: 2005-04-01
Other drugs received by patient: Panfurex; Carbolevure; Acetaminophen; Flixonase; Ultra Levura
Possible Bactrim DS side effects / adverse reactions in 30 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-07
Patient: 30 year old male
Reactions: Pruritus, Purpura, Rash Maculo-Papular
Adverse event resulted in: hospitalization
Suspect drug(s):
Transacalm
Administration route: Oral
Indication: Gastrointestinal Inflammation
Start date: 2005-03-26
End date: 2005-04-01
Bactrim DS
Administration route: Oral
Indication: Gastrointestinal Inflammation
Start date: 2005-03-26
End date: 2005-04-01
Bactrim DS
Indication: Colitis
Transacalm
Indication: Colitis
Pantoprazole Sodium
Dosage: 20 mg, 1x/day
Administration route: Oral
Start date: 2005-03-26
End date: 2005-04-01
Other drugs received by patient: Fluticasone Propionate; Nifuroxazide; Yeast Dried; Carbolevure; Acetaminophen
Possible Bactrim DS side effects / adverse reactions in 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-11
Patient: 46 year old male
Reactions: Eczema
Adverse event resulted in: hospitalization
Suspect drug(s):
Gammagard Liquid
Start date: 2011-03-01
End date: 2011-06-28
Cyclophosphamide
Administration route: Oral
Indication: Wegener's Granulomatosis
Start date: 2011-03-30
End date: 2011-06-28
Gammagard Liquid
Start date: 2011-03-01
End date: 2011-06-28
Gammagard Liquid
Indication: Wegener's Granulomatosis
Start date: 2011-03-01
End date: 2011-06-28
Gammagard Liquid
Start date: 2011-03-01
End date: 2011-06-28
Gammagard Liquid
Start date: 2011-03-01
End date: 2011-06-28
Bactrim DS
Administration route: Oral
Indication: Prophylaxis
End date: 2011-06-28
Gammagard Liquid
Start date: 2011-03-01
End date: 2011-06-28
Other drugs received by patient: Prednisone; Actonel; Coumadin; Calcidose Vitamine D
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