Rocephin Side Effects

Generic Name: ceftriaxone

Note: This page contains side effects data for the generic drug ceftriaxone. It is possible that some of the dosage forms included below may not apply to the brand name Rocephin.

It is possible that some side effects of Rocephin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ceftriaxone: injection powder for solution

As well as its needed effects, ceftriaxone (the active ingredient contained in Rocephin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ceftriaxone, check with your doctor or nurse immediately:

More common
  • Black, tarry stools
  • chest pain
  • chills
  • cough
  • fever
  • painful or difficult urination
  • 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
Less common
  • Diarrhea
Rare
  • Abdominal or stomach cramps or tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • bloody nose
  • bluish color
  • changes in skin color
  • clay-colored stools
  • convulsions
  • cough or hoarseness
  • dark urine
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of discomfort
  • feeling of warmth
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • hives
  • increased sweating
  • increased thirst
  • inflammation of the joints
  • itching
  • loss of appetite
  • lower back or side pain
  • muscle aches
  • nausea or vomiting
  • noisy breathing
  • nosebleeds
  • pain
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • skin rash
  • swelling of the foot or leg
  • swollen lymph glands
  • tenderness
  • tightness in the chest
  • troubled breathing with exertion
  • unpleasant breath odor
  • unusual weight loss
  • vomiting of blood
  • watery or bloody diarrhea
  • wheezing
  • yellowing of the eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chest pain
  • coughing up blood
  • decrease in the amount of urine
  • excessive muscle tone
  • increased menstrual flow or vaginal bleeding
  • muscle stiffness, tension, or tightness
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red irritated eyes
  • red or black, tarry stools
  • red or dark brown urine
  • red skin lesions, often with a purple center
  • restlessness
  • skin rash with a general disease
  • swelling
  • trouble sitting still
  • unpleasant breath odor

Some ceftriaxone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Rare
  • Acid or sour stomach
  • belching
  • bloated
  • change in taste
  • dizziness
  • excess air or gas in the stomach or intestines
  • full feeling
  • headache
  • heartburn
  • indigestion
  • itching of the vagina or genital area
  • loss of taste
  • pain during sexual intercourse
  • passing gas
  • stomach discomfort, upset, or pain
  • thick, white vaginal discharge with no odor or with a mild odor
Incidence not known
  • Hives or welts
  • redness, swelling, or soreness of the tongue
  • swelling or inflammation of the mouth

For Healthcare Professionals

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

Gastrointestinal

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.[Ref]

Both pseudocholelithiasis (biliary "sludging") and true cholelithiasis (ceftriaxone-containing gallstone) have been reported in association with ceftriaxone 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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Renal

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.[Ref]

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

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.[Ref]

Genitourinary

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

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.[Ref]

Nervous system

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

Endocrine

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

Respiratory

Respiratory side effects have rarely included bronchospasm and epistaxis.[Ref]

Cardiovascular

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

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.[Ref]

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.[Ref]

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.[Ref]

References

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43. Mattis LE, Saavedra JM, Shan H, Shirey RS, Powell E, Oliva-Hemker MM "Life-threatenting ceftriaxone-induced immune hemolytic anemia in a child with Crohn's disease." Clin Pediatr (Phila) 43 (2004): 175-8

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