Cefotetan Side Effects

Some side effects of cefotetan 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 cefotetan: injectable powder for injection, intravenous solution

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

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• chest pain;

• fever, chills, body aches, flu symptoms;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• severe tingling, numbness, pain, muscle weakness;

• seizure (convulsions);

• pale skin, dark colored urine, fever, confusion or weakness;

• jaundice (yellowing of the skin or eyes);

• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all; 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 of cefotetan may include:

• nausea, vomiting;

• stomach pain;

• mild diarrhea;

• vaginal itching or discharge; or

• pain, swelling, redness, or bruising where the medicine was injected.

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 cefotetan: injectable powder for injection, intravenous solution

Hematologic

Cefotetan contains a methylthiotetrazole side chain. Moxalactam, another broad spectrum cephalosporin, also has this side chain and is commonly associated with bleeding problems. This side chain is thought to be the moiety responsible for the development of hypoprothrombinemia in patients receiving these cephalosporins. Administration of parenteral vitamin K has been shown to reverse the coagulation abnormalities.

Rare cases of hemolytic anemia, sometimes fatal, are associated with cefotetan. In some cases, antibodies that react with red blood cells that have been exposed to cefotetan have been identified.

Hematologic side effects have been reported in 1.4% of patients and include eosinophilia (0.5%), positive direct Coombs' test (0.4%), thrombocytosis (0.3%), agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and increased prothrombin time with or without bleeding. Cephalosporin-class antibiotics have been associated with aplastic anemia, hemorrhage, pancytopenia, and neutropenia.

Hypersensitivity

Hypersensitivity reactions have been reported in 1.2% of patients and include rash (0.7%), pruritus (0.14%), anaphylactic reactions, and urticaria. Cephalosporin-class antibiotics have been associated with pruritus, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

There may be cross-reactivity in penicillin allergic patients. Anaphylaxis is rare with cefotetan, although three cases are reported in female patients with no known drug allergies and no known prior exposure to cefotetan.

A case of occupational contact dermatitis due to cephalosporin allergy has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.

Gastrointestinal

Gastrointestinal side effects have been reported in 1.5% of patients and have included diarrhea (1.25%), nausea (0.14%), pseudomembranous colitis, and hiccups. Cephalosporin-class antibiotics have been associated with vomiting, abdominal pain, and colitis.

Diarrhea seems to be the most common gastrointestinal side effect, although it is usually mild, self-limited, and rarely requires discontinuation of therapy. If diarrhea is persistent, testing for Clostridium difficile colitis and discontinuation of therapy is recommended. Pseudomembranous colitis may occur during or after discontinuation of therapy.

Local

Pain with intramuscular injection is common, but may be minimized by administering cefotetan with lidocaine as a diluent. Injection pain usually resolves over several minutes to one hour.

Local side effects have been reported in less than 1% of patients and include phlebitis with intravenous administration (0.3%) and discomfort (0.2%). Local pain frequently occurs with intramuscular injections.

Renal

Renal side effects have included increases in serum creatinine and blood urea nitrogen (BUN), and rarely nephrotoxicity. Cephalosporin-class antibiotics have been associated with toxic nephropathy and renal dysfunction.

Although mild changes may occur in serum creatinine, blood urea nitrogen and liver function tests, these are usually transient and do not require discontinuation of therapy. No increases in urinary excretion of alanine aminopeptidase (AAP) or N-acetyl-beta-D-glucosaminidase (NAG), enzymes indicative of renal tubular damage, were noted in one study. However, at least one case of acute interstitial nephritis is associated with cefotetan. The authors believed this was due to cefotetan, but could not rule out nephrotoxicity due to concomitantly administered piperacillin.

Hepatic

Hepatic side effects have occurred in 1.2% of patients and include increases in ALT (SGPT) (0.7%), AST (SGOT) (0.3%), alkaline phosphatase (0.14%), and LDH (0.14%). Cephalosporin-class antibiotics have been associated with hepatic dysfunction including cholestasis and elevated bilirubin.

Other

Other side effects have rarely included fever. Cephalosporin-class antibiotics have been associated with superinfection.

Genitourinary

Genitourinary side effects associated with cephalosporin-class antibiotics have included vaginitis and vaginal candidiasis.

Nervous system

Nervous system side effects associated with some cephalosporin-class antibiotics have included seizures, especially in patients with renal dysfunction.

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