Applies to cefotetan: injection powder for solution.

Serious side effects of Cefotetan

Along with its needed effects, cefotetan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cefotetan:

Less common

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• bloating
• chest pain
• chills
• cough
• dark urine
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing
• fever
• general body swelling
• headache
• increased thirst
• loss of appetite
• nausea or vomiting
• nosebleeds
• pain
• painful or difficult urination
• pale skin
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• yellowing of the eyes or skin

Rare

• Blood in the urine
• bluish color
• change in frequency of urination or amount of urine
• changes in skin color
• drowsiness
• increased thirst
• swelling of the feet or lower legs
• tenderness
• weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• cough or hoarseness
• coughing up blood
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• increased menstrual flow or vaginal bleeding
• itching
• itching of the vagina or genital area
• joint or muscle pain
• lower back or side pain
• nosebleeds
• pain during sexual intercourse
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red or black, tarry stools
• red or dark brown urine
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• skin rash
• sudden decrease in the amount of urine
• swollen or painful glands
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• unpleasant breath odor
• vomiting of blood
• wheezing

For Healthcare Professionals

Applies to cefotetan: injectable powder for injection, intravenous powder for injection, intravenous solution.

Hematologic

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

Gastrointestinal

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

Other

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

Genitourinary

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

Nervous system

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