Gantrisin Side Effects

Generic name: sulfisoxazole

Note: This document contains side effect information about sulfisoxazole. Some of the dosage forms listed on this page may not apply to the brand name Gantrisin.

Some side effects of Gantrisin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sulfisoxazole: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sulfisoxazole (the active ingredient contained in Gantrisin) hives; difficulty 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, body aches, flu symptoms;

• cough, feeling short of breath, pale skin, joint pain, unusual bruising;

• fast or pounding heartbeat;

• blue lips or fingernails, feeling light-headed, fainting;

• swelling around your neck or throat;

• urinating more or less than usual;

• severe pain in your side or lower back, blood in your urine;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• agitation, confusion, unusual thoughts or behavior; or

• seizure (black-out or convulsions).

Less serious side effects of sulfisoxazole may include:

• mild stomach pain, bloating, gas;

• headache, dizziness;

• ringing in your ears; or

• swollen, black, or "hairy" tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sulfisoxazole: compounding powder, oral suspension, oral tablet

General

In general, although not every side effect listed in the side effects section may have been reported with the use of sulfisoxazole (the active ingredient contained in Gantrisin) they have all been reported with the use of one or more sulfonamide compounds.

Sulfisoxazole was generally well tolerated. Less than 0.1% of patients experienced serious side effects from sulfisoxazole.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, angioedema, arteritis and vasculitis, serum sickness, conjunctival and scleral injection, generalized allergic reactions, and allergic myocarditis.

The use of sulfonamide antibiotics is associated with large increases in the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis, although these phenomena are rare as a whole.

Dermatologic

Dermatologic side effects have included exfoliative dermatitis, rash, pruritus, photosensitivity, periarteritis nodosa, systemic lupus erythematosus, and generalized skin eruptions.

Hematologic

Hematologic side effects have included agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia, purpura, hemolytic anemia, eosinophilia, clotting disorders including hypoprothrombinemia, hypofibrinogenemia, sulfhemoglobinemia, and methemoglobinemia.

Hepatic

Hepatic side effects have included hepatitis, hepatocellular necrosis, and jaundice. Elevated liver-associated enzymes have been reported in patients with hepatitis. Rare cases of hepatic necrosis have been associated with some sulfonamides.

Renal

Renal side effects have included elevated BUN and creatinine, acute renal failure, nephritis, and nephrosis with oliguria and anuria. The frequency of renal complications is lower with the more soluble sulfonamides, such as sulfisoxazole (the active ingredient contained in Gantrisin)

Genitourinary

Genitourinary side effects have included crystalluria, hematuria, and urinary retention.

Cardiovascular

Cardiovascular side effects have included tachycardia, palpitations, syncope, cyanosis, angioedema, arteritis, and vasculitis.

Gastrointestinal

Gastrointestinal side effects have included pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, enlarged salivary gland, and pancreatitis.

Pseudomembranous colitis has occurred during or after sulfisoxazole therapy.

Nervous system

Nervous system side effects have included headache, dizziness, peripheral neuritis, paresthesia, convulsions, drowsiness, hearing loss, insomnia, tinnitus, vertigo, ataxia, and intracranial hypertension.

Psychiatric

Psychiatric side effects have included psychosis, hallucination, disorientation, depression, anxiety, and apathy.

Other

Other side effects have included edema (including periorbital), pyrexia, weakness, fatigue, lassitude, rigors, flushing, and chills.

Respiratory

Respiratory side effects have included cough, shortness of breath, pulmonary infiltrates, and pneumonitis.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia.

Endocrine

Endocrine side effects have been reported rarely in patients receiving sulfonamides and have included goiter development, diuresis, and hypoglycemia.

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