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Septra

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Septra

Septra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Septra (trimethoprim and sulfamethoxazole) is used to treat ear infections, urinary tract infections, bronchitis, traveler's diarrhea, methicillin-resistant Staphylococcus aureus (MRSA) and Pneumocystis carinii pneumonia. It is a combination of two antibiotics. This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, or loss of appetite.

The dose of Septra varies depending on the condition being treated. Septra may interact with seizure medications, diuretics (water pills), blood thinners, methotrexate, or ACE inhibitors. Tell your doctor all medications you use. During pregnancy, Septra should be used only when prescribed. It should not be used near the expected delivery date because of possible harm to the fetus. This drug passes into breast milk. While there have been no reports of harm to healthy infants, this drug may have undesirable effects on infants who are ill or premature or have certain disorders (jaundice, high blood levels of bilirubin, G6PD deficiency). Breast-feeding is not recommended for infants with these conditions. Consult your doctor before breast-feeding.

Our Septra (trimethoprim and sulfamethoxazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Septra in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • fever, chills, swollen glands, body aches, flu symptoms, sores in your mouth and throat;
  • new or worsening cough;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • severe tingling or numbness, slow heart rate, weak pulse, muscle weakness;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • hallucinations, seizure (convulsions);
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, or feeling jittery);
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • vomiting;
  • painful or swollen tongue;
  • dizziness, spinning sensation;
  • ringing in your ears; or
  • tired feeling, sleep problems (insomnia).

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 Septra (Trimethoprim and Sulfamethoxazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Septra Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle weakness, mental/mood changes, blood in the urine, change in the amount of urine, extreme drowsiness, signs of low blood sugar (such as nervousness, shakiness, sweating, hunger).

Get medical help right away if you have any very serious side effects, including: persistent headache, neck stiffness, seizures, slow/irregular heartbeat.

This medication may rarely cause serious (possibly fatal) allergic reactions and other side effects such as a severe peeling skin rash (such as Stevens-Johnson syndrome), blood disorders (such as agranulocytosis, aplastic anemia), liver damage, or lung injury. If you notice any of the following, get medical help right away: skin rash/blisters, itching/swelling (especially of the face/tongue/throat), persistent sore throat or fever, paleness, joint pain/aches, persistent cough, trouble breathing, easy bleeding/bruising, yellowing eyes or skin, persistent nausea/vomiting, unusual fatigue, dark urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Septra (Trimethoprim and Sulfamethoxazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Septra FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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, OTHER BLOOD DYSCRASIAS, AND HYPERSENSITIVITY OF THE RESPIRATORY TRACT (SEE WARNINGS).

Hematologic

Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

Allergic

Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch- Schönlein 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

Hyperkalemia, hyponatremia (see PRECAUTIONS: Electrolyte Abnormalities).

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. Cases of rhabdomyolysis have been reported with SEPTRA, mainly in AIDS patients.

Respiratory System

Cough, shortness of breath, and pulmonary infiltrates (see WARNINGS).

Miscellaneous

Weakness, fatigue, insomnia.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of trimethoprimsulfamethoxazole. 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:

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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