Zotrim

Zotrim

Zotrim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zotrim (sulfamethoxazole/trimethoprim and phenazopyridine hydrochloride) is used to treat urinary tract infections. Zotrim is a combination of two tablets: sulfamethoxazole and trimethoprim, which are antibacterial medications, and phenazopyridine hydrochloride, which is a pain reliever. Common side effects include nausea, vomiting, anorexia, skin rash, or hives. The phenazopyridine hydrochloride produces an orange to red color in the urine.

The adult dose of trimethoprim/sulfamethoxazole is one (1) double strength (160 mg/ 800 mg) tablet every 12 hours for 10 days. The adult dose of phenazopyridine hydrochloride is one (1) 200 mg tablet 3 times a day after meals, taken for no more than 2 days. Zotrim may interact with diuretics (water pills), blood thinners, phenytoin, or methotrexate. Tell your doctor all medications you use. During pregnancy, Zotrim should be used only if prescribed. It may interfere with folic acid absorption. Sulfamethoxazole/trimethoprim is excreted in breast milk and may cause undesirable effects in a nursing baby. Consult your doctor before breastfeeding.

Our Zotrim (sulfamethoxazole/trimethoprim and phenazopyridine hydrochloride) 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 Prescribing information?

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

Zotrim FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Trimethoprim/Sulfamethoxazole: 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 section).

Phenazopyridine Hydrochloride: Headache, rash and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described.

Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been described, usually at overdosage levels (see OVERDOSAGE section).

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-Schonlein 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, and crystalluria.

Metabolic: Hyperkalemia, hyponatremia.

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.

Respiratory System: Cough, shortness of breath, and pulmonary infiltrates (see WARNINGS section).

Miscellaneous: Weakness, fatigue, insomnia.

Read the entire FDA prescribing information for Zotrim (Sulfamethoxazole, Trimethoprim, Phenazopyridine) »

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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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