BACTRIM SIDE EFFECTS
- Generic Name: trimethoprim and sulfamethoxazole
- Brand Name: Bactrim
- Drug Class: Antibiotics, Combos, Sulfonamides
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Embryo-fetal Toxicity
- Hypersensitivity and Other Fatal Reactions
- Thrombocytopenia
- Clostridioides difficile-Associated Diarrhea
- Sulfite Sensitivity
- Risk Associated with Concurrent Use of Leucovorin for Pneumocystis jirovecii Pneumonia
- Propylene Glycol Toxicity
- Infusion Reactions
- Hypoglycemia
- Electrolyte Abnormalities
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, and anorexia) and allergic skin reactions (such as rash and urticaria).
Local reaction, pain and slight irritation on intravenous (IV) administration are infrequent. Thrombophlebitis has been observed.
Table 1: Adverse Reactions Reported with BACTRIM
| Body System | Adverse Reactions |
| Hematologic |
|
| Allergic Reactions |
|
| Gastrointestinal |
|
| Genitourinary |
|
| Metabolic and Nutritional |
|
| Neurologic |
|
| Psychiatric |
|
| Endocrine |
|
| Musculoskeletal |
|
| Respiratory |
|
| Miscellaneous |
|
| Eye Disorders |
|
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of BACTRIM. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- Thrombotic thrombocytopenia purpura
- Idiopathic thrombocytopenic purpura
- QT prolongation resulting in ventricular tachycardia and torsade de pointes
- Metabolic acidosis
SRC: NLM .