Rocephin Side Effects

Generic name: ceftriaxone

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

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking ceftriaxone (the active ingredient contained in Rocephin) 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, swollen glands, rash or itching, joint pain, or general ill feeling;

• white patches or sores inside your mouth or on your lips;

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

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

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

• urinating less than usual or not at all;

• seizure (convulsions);

• swelling, pain, or irritation where the injection was given;

• chalky-colored stools, stomach pain just after eating a meal, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back; 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 ceftriaxone may include:

• a hard lump where the injection was given;

• nausea, vomiting, upset stomach;

• headache, dizziness, overactive reflexes;

• pain or swelling in your tongue;

• sweating; or

• vaginal itching or discharge.

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 ceftriaxone: injectable powder for injection, intramuscular kit, intravenous solution

Gastrointestinal

Both pseudocholelithiasis (biliary "sludging") and true cholelithiasis (ceftriaxone-containing gallstone) have been reported in association with ceftriaxone (the active ingredient contained in Rocephin) dosages greater than 2 grams per day. A false-positive hepatobiliary scan occurred in a patient receiving ceftriaxone. A repeat test two weeks after discontinuation of ceftriaxone was normal.

Ceftriaxone-associated diarrhea may, in rare cases, be associated with C difficile pseudomembranous colitis. If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Gastrointestinal side effects have included diarrhea (2.7%); nausea, vomiting, and dysgeusia (less than 1%); gallbladder sludge, biliary lithiasis, colitis, flatulence, dyspepsia, abdominal pain (less than 0.1%); cholelithiasis, and pseudomembranous colitis. Rare cases of pancreatitis, possibly secondary to biliary obstruction, have been reported. Stomatitis and glossitis have been reported during postmarketing experience.

Hematologic

Ceftriaxone-associated neutropenia and thrombocytopenia are reversible upon discontinuation of therapy. Fever and rash often accompany these conditions.

Nineteen cases (10 adults, 9 children) of immune hemolytic anemia have been reported, 9 of which were fatal. Symptoms may occur within minutes or weeks of drug administration. Initial symptoms included tachycardia, dyspnea, pallor, back or leg pain, and decrease in hemoglobin levels.

Hematologic side effects have included eosinophilia (6%), thrombocytosis (5.1%), and leukopenia (2.1%). Anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia, and prothrombin time prolongation have been reported in less than 1% of patients. Agranulocytosis, lymphocytosis, leukocytosis, monocytosis, basophilia, and decreased prothrombin time have been reported in less than 0.1% of patients. Cephalosporins as a class have also been associated with aplastic anemia, hemorrhage and pancytopenia.

Hypersensitivity

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

A case of an acute generalized exanthematic pustulosis (AGEP) has been reported following administration of ceftriaxone (the active ingredient contained in Rocephin) This was characterized by the appearance of an erythematous and generalized scarlatiniform rash with plaques covered by small nonfollicular pustules on the thighs, abdomen, and lower extremities. Ceftriaxone was discontinued and the AGEP was completely resolved after two weeks.

An allergic reaction manifested by itching, maculopapular rash, hyperthermia, flushing has been reported in a patient with X-linked agammaglobulinemia in the absence of IgE. T cell involvement was proposed as the mechanism.

Cross-sensitivity with other cephalosporins and penicillins may occur; however, the incidence is unknown.

Hypersensitivity side effects have included rash (1.7%), pruritus, fever, chills, anaphylaxis, and serum sickness. Allergic pneumonitis, allergic reaction, contact dermatitis, and acute generalized exanthematic pustulosis have also been reported. Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, drug fever, serum sickness-like reaction, and toxic epidermal necrolysis.

Renal

Patients with underlying renal dysfunction may be at higher risk for these conditions.

Renal side effects have included elevations of BUN (1.2%), creatinine, urinary casts, renal precipitations, and nephrolithiasis. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Local

Local side effects have included pain, induration, and tenderness in 1% of patients. Phlebitis has occurred in less than 1% of patients after intravenous administration. Intramuscular injection has been associated with warmth, tightness and induration in 17% of patients receiving the 350 mg/mL solution and 5% of patients receiving the 250 mg/mL solution. Lidocaine 1% may be used as a diluent to decrease pain at the injection site.

Genitourinary

Genitourinary side effects have included moniliasis, vaginitis, glycosuria, and hematuria. Oliguria has been reported during postmarketing experience.

Hepatic

Hepatic side effects have included elevations of SGOT (3.1%), SGPT (3.3%), alkaline phosphatase (less than 1%), bilirubin (less than 1%), and jaundice (less than 0.1%). Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Nervous system

Nervous system side effects have included headache, dizziness, and seizures. Cephalosporin class antibiotics have been associated with reversible hyperactivity and hypertonia.

Endocrine

Endocrine side effects have included diaphoresis and flushing (less than 1%).

Respiratory

Respiratory side effects have rarely included bronchospasm and epistaxis.

Cardiovascular

Cardiovascular side effects have included palpitations (less than 0.1%) and thrombus.

Immunologic

Immunologic side effects have included life-threatening and fatal cases of immune hemolytic anemia, with symptoms of pallor, tachycardia, hypotension, dyspnea, and severe back pain. Most of these patients had preexisting hematologic or immunodeficiency disorders, and 1 had Crohn's disease.

Dermatologic

Dermatologic side effects have included exanthema, allergic dermatitis, urticaria, edema, and isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome/toxic epidermal necrolysis) during postmarketing experience.

Other

Other side effects associated with cephalosporin class antibiotics have included superinfection, positive direct Coombs' test, false-positive test for urinary glucose, and elevated LDH.

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