Bactrim

• Overview
• Consumer Information
• Professional Information

 

Bactrim Side Effects Center

What Is Bactrim?

Bactrim (sulfamethoxazole and trimethoprim) DS is a combination of two antibiotics used to treat urinary tract infections, acute otitis media, bronchitis, Shigellosis, Pneumocystis pneumonia, traveler's diarrhea, methicillin-resistant Staphylococcus aureus (MRSA), and other bacterial infections susceptible to this antibiotic. Bactrim is available as a generic drug.

What Are Side Effects of Bactrim?

Common side effects of Bactrim include:

• loss of appetite,
• nausea,
• vomiting,
• painful or swollen tongue,
• dizziness,
• spinning sensation,
• ringing in your ears,
• tiredness, or
• sleep problems (insomnia).

Tell your doctor if you experience serious side effects of Bactrim including:

• bruising or bleeding,
• aplastic anemia,
• jaundice,
• hepatic necrosis,
• mouth sores,
• joint aches,
• severe skin rashes,
• itching, and
• sore throat.

Dosage for Bactrim

Bactrim is available in tablets in two strengths; 400 mg sulfamethoxazole and 80 mg trimethoprim and the "DS" form which means double strength, 800 mg sulfamethoxazole and 160 mg trimethoprim. Patients should follow their doctor's instructions and take all of the Bactrim prescribed. Patients allergic to sulfa compounds should not take Bactrim.

What Drugs, Substances, or Supplements Interact with Bactrim?

Bactrim may interact with many drugs; the patient and prescribing doctor should be aware of any potential interactions.

Bactrim During Pregnancy and Breastfeeding

Bactrim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; the same situation exists for women who are breastfeeding and their neonates.

Additional Information

Our Bactrim DS Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Bactrim Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, cough, chest pain, shortness of breath, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, joint pain, muscle aches, severe weakness, pale skin, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• any skin rash, no matter how mild;
• yellowing of your skin or eyes;
• a seizure;
• new or unusual joint pain;
• increased or decreased urination;
• swelling, bruising, or irritation around the IV needle;
• increased thirst, dry mouth, fruity breath odor;
• new or worsening cough, fever, trouble breathing;
• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• low blood cell counts--fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• nausea, vomiting, loss of appetite; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bactrim (Trimethoprim and Sulfamethoxazole)

 

Bactrim Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

• Embryo-fetal Toxicity [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity and Other Fatal Reactions [see WARNINGS AND PRECAUTIONS]
• Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
• Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Sulfite Sensitivity [see WARNINGS AND PRECAUTIONS]
• Risk Associated with Concurrent Use of Leucovorin for Pneumocystis jirovecii Pneumonia [see WARNINGS AND PRECAUTIONS]
• Propylene Glycol Toxicity [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]
• Infusion Reactions [see WARNINGS AND PRECAUTIONS]
• Hypoglycemia [see WARNINGS AND PRECAUTIONS]
• Electrolyte Abnormalities [see WARNINGS AND PRECAUTIONS]

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 3: Adverse Reactions Reported with BACTRIM

Body System	Adverse Reactions
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 Conjunctival and scleral injection Photosensitivity Pruritus Urticaria Rash Periarteriitis nodosa Systemic lupus erythematosus
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
Metabolic and Nutritional	Hyperkalemia Hyponatremia [see WARNINGS AND PRECAUTIONS]
Neurologic	Aseptic meningitis Convulsions Peripheral neuritis Ataxia Vertigo Tinnitus Headache
Psychiatric	Hallucinations Depression Apathy Nervousness
Endocrine	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 in patients receiving sulfonamides)
Musculoskeletal	Arthralgia Myalgia Rhabdomyolysis
Respiratory	Cough Shortness of breath Pulmonary infiltrates
Miscellaneous	Weakness Fatigue Insomnia
Eye Disorders	Uveitis5

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

Read the entire FDA prescribing information for Bactrim (Trimethoprim and Sulfamethoxazole)

&Copy; Bactrim Patient Information is supplied by Cerner Multum, Inc. and Bactrim Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.