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Zinacef Side Effects

Generic Name: cefuroxime

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

For the Consumer

Applies to cefuroxime: oral powder for suspension, oral tablet

Along with its needed effects, cefuroxime (the active ingredient contained in Zinacef) 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 immediately if any of the following side effects occur while taking cefuroxime:

More common
  • Chills
  • diarrhea
  • fever
  • general feeling of illness or discomfort
  • headache
  • itching of the vagina or genital area
  • pain during sexual intercourse
  • rigidity
  • sweating
  • thick, white vaginal discharge with no odor or with a mild odor
Less common
  • Black, tarry stools
  • chest pain
  • cough
  • loose stools
  • 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
Rare
  • Back, leg, or stomach pains
  • bladder pain
  • bleeding gums
  • bloody or cloudy urine
  • body aches or pain
  • burning while urinating
  • dark urine
  • difficulty with breathing
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • general body swelling
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea or vomiting
  • nosebleeds
  • pain or tenderness around the eyes and cheekbones
  • pale skin
  • pink or red urine
  • sneezing
  • stuffy or runny nose
  • swelling of the joints
  • swollen glands
  • tightness of chest or wheezing
  • white or brownish vaginal discharge
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
  • yellowing of the eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloody, black, or tarry stools
  • clay-colored stools
  • cough or hoarseness
  • coughing up blood
  • decrease in urine output or decrease in urine-concentrating ability
  • feeling of discomfort
  • fever with or without chills
  • general feeling of tiredness or weakness
  • high fever
  • hives
  • increased menstrual flow or vaginal bleeding
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • paralysis
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red or black, tarry stools
  • red or dark brown urine
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • swollen lymph glands
  • swollen or painful glands
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting of blood

Some side effects of cefuroxime may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
  • diaper rash
Rare
  • Abdominal or stomach cramps
  • acid or sour stomach
  • belching
  • bloated
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • flushing or redness of the skin
  • full feeling
  • gas in the stomach
  • heartburn
  • indigestion
  • irritability
  • irritation or soreness of the mouth
  • itching skin
  • muscle pain or stiffness
  • muscle spasm of the neck
  • passing gas
  • restlessness
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, or pain
  • swelling of the tongue
  • thirst
  • trouble sitting still
  • unusually warm skin
  • watering of the mouth and drooling
  • weight loss
Incidence not known
  • Hives or welts
  • redness of the skin

For Healthcare Professionals

Applies to cefuroxime: injectable powder for injection, intravenous solution, oral powder for reconstitution, oral tablet

General

Cefuroxime (the active ingredient contained in Zinacef) was generally well tolerated. The side effects most commonly reported with the parenteral formulation have included neutropenia, eosinophilia, transient liver enzyme/bilirubin elevations, and injection site reactions. The side effects most commonly reported with the oral formulations have included Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances, and transient liver enzyme elevations.[Ref]

Side effects may be more likely and more severe in patients with liver disease and/or renal dysfunction.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea/loose stools, nausea/vomiting, abdominal pain, nausea
Uncommon (0.1% to 1%): Abdominal cramps, flatulence, indigestion, mouth ulcers, swollen tongue, dyspepsia, gastrointestinal (GI) infection, ptyalism/excess salivation, GI disturbance, vomiting
Frequency not reported: Abdominal discomfort, dry mouth, Clostridium difficile-associated diarrhea
Postmarketing reports: GI disturbances (including diarrhea, nausea, vomiting, abdominal pain), pseudomembranous colitis

Cephalosporin-class:
-Frequency not reported: Vomiting, abdominal pain, colitis[Ref]

The onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.[Ref]

Hepatic

Common (1% to 10%): Transient increase in AST, transient increase in ALT, transient increase in liver enzyme levels
Uncommon (0.1% to 1%): Transient increase in bilirubin
Postmarketing reports: Hepatic dysfunction, hepatitis, cholestasis, jaundice (mainly cholestatic)

Cephalosporin-class:
-Frequency not reported: Hepatic dysfunction (including cholestasis)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Sleepiness, somnolence, hyperactivity
Postmarketing reports: Seizures, encephalopathy[Ref]

Cephalosporin-class antibiotics (including this drug) have been associated with seizures, especially in patients with renal dysfunction when the dose was not reduced.[Ref]

Hypersensitivity

Delayed hypersensitivity reaction to this drug has been reported in 2.9% of patients with history of delayed hypersensitivity to penicillin (but not a cephalosporin).

Rare cases of severe hypersensitivity reactions (including erythema multiforme, toxic epidermal necrolysis [exanthematic necrolysis], drug fever, serum sickness-like reaction, anaphylaxis, Stevens-Johnson syndrome) have been reported.[Ref]

Common (1% to 10%): Delayed hypersensitivity reaction
Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, pruritus, urticaria)
Rare (0.01% to 0.1%): Severe hypersensitivity reactions
Frequency not reported: Serum sickness
Postmarketing reports: Anaphylaxis, serum sickness-like reaction[Ref]

Hematologic

Profound leukopenia has sometimes been profound with oral therapy.[Ref]

Common (1% to 10%): Eosinophilia, decreased hemoglobin and hematocrit, neutropenia, decreased hemoglobin concentration
Uncommon (0.1% to 1%): Positive Coombs test, leukopenia, thrombocytopenia
Frequency not reported: Autoimmune granulocytopenia, increased coagulation time
Postmarketing reports: Hemolytic anemia, pancytopenia, increased prothrombin time

Cephalosporin-class:
-Frequency not reported: Aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis[Ref]

Renal

Acute renal failure has been reported. Renal function improved after this drug was stopped, and deteriorated upon rechallenge.[Ref]

Frequency not reported: Increased BUN, increased creatinine, decreased CrCl, acute renal failure
Postmarketing reports: Renal dysfunction, interstitial nephritis (including reversible fever, azotemia, pyuria, eosinophilia)

Cephalosporin-class:
-Frequency not reported: Toxic nephropathy[Ref]

Genitourinary

Common (1% to 10%): Vaginitis
Uncommon (0.1% to 1%): Vulvar itch, dysuria, vaginal candidiasis, vaginal discharge, vaginal itch, urethral pain/bleeding, kidney pain, urinary tract infection, vaginal irritation

Cephalosporin-class:
-Frequency not reported: Vaginitis (including vaginal candidiasis)[Ref]

Dermatologic

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]

Common (1% to 10%): Diaper/nappy rash
Uncommon (0.1% to 1%): Rash, urticaria/hives, pruritus, erythema
Rare (0.01% to 0.1%): Erythema multiforme, toxic epidermal necrolysis (exanthematic necrolysis), Stevens-Johnson syndrome
Frequency not reported: Acute generalized exanthematous pustulosis
Postmarketing reports: Angioedema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous vasculitis[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Cephalosporin-class:
-Frequency not reported: Urine glucose false positive[Ref]

Other

Common (1% to 10%): Transient increase in LDH, transient increase in alkaline phosphatase, Candida overgrowth, dislike of taste
Uncommon (0.1% to 1%): Chest pain/tightness, chills, thirst, viral illness, candidiasis, fever
Rare (0.01% to 0.1%): Drug fever
Frequency not reported: Clostridium difficile overgrowth, disulfiram reaction[Ref]

Respiratory

Uncommon (0.1% to 1%): Shortness of breath, sinusitis, cough, upper respiratory infection[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle cramps, muscle stiffness, muscle spasm of the neck, lockjaw-type reaction, joint swelling, arthralgia[Ref]

Cardiovascular

A 90-year-old man, with no history of coronary artery disease, diabetes mellitus, hypertension, or hyperlipidemia, was administered 750 mg cefuroxime (the active ingredient contained in Zinacef) axetil IM for urinary tract infection. About 10 minutes after the injection, the patient developed chest pain and pruritic skin rashes. Kounis syndrome type I variant was diagnosed secondary to the drug. Five days after stopping the drug, the patient's symptoms had resolved.[Ref]

Uncommon (0.1% to 1%): Tachycardia
Frequency not reported: Kounis syndrome type I variant[Ref]

Local

Common (1% to 10%): Injection site reactions (including pain, thrombophlebitis), thrombophlebitis with IV administration
Frequency not reported: Pain at IM injection site[Ref]

Immunologic

Common (1% to 10%): Jarisch-Herxheimer reaction[Ref]

Psychiatric

Uncommon (0.1% to 1%): Irritable behavior

References

1. Bulpitt D, Potter CE, Jaderberg M "A large scale, general practice based investigation into the clinical efficacy and tolerability of cefuroxime axetil in women with uncomplicated urinary tract infect." Curr Med Res Opin 12 (1991): 318-24

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Ceftin (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.

4. Yangco BG, Lowe J, Nolen TM, et al "A multicenter trial comparing the efficacy and safety of cefuroxime axetil and cefaclor in pneumonia of adults." Clin Ther 12 (1990): 440-6

5. Hebblethwaite EM, Brown GW, Cox DM "A comparison of the efficacy and safety of cefuroxime axetil and augmentin in the treatment of upper respiratory tract infections." Drugs Exp Clin Res 13 (1987): 91-4

6. Henry D, Ruoff GE, Rhudy J, Puopolo A, Drehobl M, Schoenberger J, Giguere G, Collins JJ "Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with secondary bacterial infections of acute bronchitis." Clin Ther 17 (1995): 861-74

7. Griffiths GK, Vandenburg MJ, Wight LJ, et al "Efficacy and tolerability of cefuroxime axetil in patients with upper respiratory tract infections." Curr Med Res Opin 10 (1987): 555-61

8. Henry D, Ruoff GE, Rhudy J, Puopolo A, Drehobl M, Schoenberger J, Giguere G, Collins JJ "Effectiveness of short-course therapy (5 days) with cefuroxime axetil in treatment of secondary bacterial infections of acute bronchitis." Antimicrob Agents Chemother 39 (1995): 2528-34

9. Pines A, Raafat H, Kennedy MR, Mullinger BM "Experience with cefuroxime in 190 patients with severe respiratory infections." Chemotherapy 26 (1980): 212-7

10. "Product Information. Zinacef (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.

11. Sommers D, Van Wyk M, Williams PE, Harding SM "Pharmacokinetics and tolerance of cefuroxime axetil in volunteers during repeated dosing." Antimicrob Agents Chemother 25 (1984): 344-7

12. Cannon SR, Dyson PH, Sanderson PJ "Pseudomembranous colitis associated with antibiotic prophylaxis in orthopaedic surgery." J Bone Joint Surg Br 70 (1988): 600-2

13. Abramowicz M, Aaron H "Cefuroxime axetil." Med Lett Drugs Ther 30 (1988): 57-9

14. Higuera F, Hidalgo H, Feris J, Giguere G, Collins JJ "Comparison of oral cefuroxime axetil and oral amoxycillin/clavulanate in the treatment of community-acquired pneumonia." J Antimicrob Chemother 37 (1996): 555-64

15. Holloway KL, Smith KW, Wilberger JE, Jemsek JG, Giguere GC, Collins JJ "Antibiotic prophylaxis during clean neurosurgery: a large, multicenter study using cefuroxime." Clin Ther 18 (1996): 84-94

16. Wormser GP "Clinical practice. Early Lyme disease." N Engl J Med 354 (2006): 2794-801

17. Baniasadi S, Fahimi F, Mansouri D "Serum sickness-like reaction associated with cefuroxime and ceftriaxone." Ann Pharmacother 41 (2007):

18. Romano A, Mayorga C, Torres MJ, Artesani MC, Suau R, Sanchez F, Perez E, Venuti A, Blanca M "Immediate allergic reactions to cephalosporins: Cross-reactivity and selective responses." J Allerg Clin Immunol 106 (2000): 1177-83

19. Saeed SAM, Bazza M, Zaman M, Ryatt KS "Cefuroxime induced lymphomatoid hypersensitivity reaction." Postgrad Med J 76 (2000): 577-9

20. Romano A, Quaratino D, Venuti A, Venemalm L, Mayorga C, Blanca M "Selective type-1 hypersensitivity to cefuroxime." J Allergy Clin Immunol 101 (1998): 564-5

21. Filipe P, Almeida RSLS, Rodrigo FG "Occupational allergic contact dermatitis from cephalosporins." Contact Dermatitis 34 (1996): 226

22. Viken R, Van Arsdel PP "Allergy to cephalosporins." JAMA 265 (1991): 2254

23. Murphy MF, Metcalfe P, Grint PC, et al "Cephalosporin-induced immune neutropenia." Br J Haematol 59 (1985): 9-14

24. Malloy CA, Kiss JE, Challapalli M "Cefuroxime-induced immune hemolysis." J Pediatr 143 (2003): 130-2

25. Goddard JK, Janning SW, Gass JS, Wilson RF "Cefuroxime-induced acute renal failure." Pharmacotherapy 14 (1994): 488-91

26. Leong CL, Thiruventhiran T "Cefuroxime-induced acute renal failure." Nephron 84 (2000): 185

27. Manley HJ, Bailie GR, Eisele G "Bilateral renal cortical necrosis associated with cefuroxime axetil." Clin Nephrol 49 (1998): 268-70

28. Cohen AD, Cagnano E, Halevy S "Acute generalized exanthematous pustulosis mimicking toxic epidermal necrolysis." Int J Dermatol 40 (2001): 458-61

29. Mattes JA "Antabuse reaction with ceftin." Am J Psychiatry 163 (2006): 2019-20

30. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

31. Biteker M, Duran NE, Biteker FS, et al. "Kounis syndrome secondary to cefuroxime-axetil use in an octogenerian." J Am Geriatr Soc 56 (2008): 1757-1758

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

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