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Ceftin

Last reviewed on RxList: 10/30/2017
Ceftin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/30/2017

Ceftin (cefuroxime) is a cephalosporin antibiotic. Ceftin is available as a generic drug and is prescribed to treat infections with susceptible bacteria including skin and middle ear infections, tonsillitis, throat infections, laryngitis, bronchitis, pneumonia, urinary tract infections, and gonorrhea. Common side effects of Ceftin include:

Tell your doctor if you experience serious side effects of Ceftin including watery or bloody diarrhea, fever, chills, body aches, flu symptoms, chest pain, fast or pounding heartbeats, unusual bleeding, blood in your urine or dark colored urine, seizure (convulsions), confusion, weakness, jaundice (yellowing of the skin or eyes), severe blistering/peeling/red skin rash, bruising, severe tingling, numbness, pain, muscle weakness, increased thirst, loss of appetite, swelling, weight gain, shortness of breath, painful or difficult urination, or urinating less than usual or not at all.

Ceftin (cefuroxime) is a cephalosporin antibiotic. Ceftin is available as a generic drug and is prescribed to treat infections with susceptible bacteria including skin and middle ear infections, tonsillitis, throat infections, laryngitis, bronchitis, pneumonia, urinary tract infections, and gonorrhea. Common side effects of Ceftin include diarrhea, dizziness, headache, drowsiness, itching/swelling, rash, nausea, vomiting, abdominal pain, stomach upset, gas, headache, itching or rash, hives, cough, stuffy nose, stiff or tight muscles, muscle pain, joint pain or swelling, restlessness, irritability, hyperactivity, vaginal itching or discharge, unusual or unpleasant taste in the mouth white patches or sores in the mouth, and diaper rash (in infants taking liquid cefuroxime).

Ceftin oral dose range in adults is from 125mg to 500mg twice daily for 7-10 days and dosage in children is usually weight based. Drug interactions with Ceftin include vaccines (for example, typhoid vaccine) and probenecid. Ceftin use during pregnancy may lead to adverse effects in the newborn. Ceftin is found in breast milk.

Our Ceftin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ceftin Consumer Information

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

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • jaundice (yellowing of the skin or eyes);
  • skin rash, bruising, severe tingling, or numbness;
  • seizure (black-out or convulsions);
  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; 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.

Common side effects may include:

  • diarrhea;
  • nausea, vomiting;
  • unusual or unpleasant taste in your mouth; or
  • diaper rash in an infant taking liquid cefuroxime.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ceftin (Cefuroxime Axetil)

Ceftin Professional Information

SIDE EFFECTS

The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label:

Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tablets

Multiple-Dose Dosing Regimens With 7 To 10 Days’ Duration

In multiple-dose clinical trials, 912 subjects were treated with CEFTIN (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with CEFTIN who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse reactions increased with the higher recommended doses.

The adverse reactions in Table 5 are for subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.

Table 5: Adverse Reactions (≥1%) after Multiple-Dose Regimens with CEFTIN Tablets

Adverse Reaction CEFTIN
(n = 912)
Blood and lymphatic system disorders
Eosinophilia 1%
Gastrointestinal disorders
Diarrhea 4%
Nausea/Vomiting 3%
Investigations
Transient elevation in AST 2%
Transient elevation in ALT 2%
Transient elevation in LDH 1%

The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.

Immune System Disorders: Hives, swollen tongue.

Metabolism and Nutrition Disorders: Anorexia.

Nervous System Disorders: Headache.

Cardiac Disorders: Chest pain.

Respiratory Disorders: Shortness of breath.

Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers.

Skin and Subcutaneous Tissue Disorders: Rash, itch.

Renal and Urinary Disorders: Dysuria.

Reproductive System and Breast Disorders: Vaginitis, vulvar itch.

General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.

Investigations: Positive Coombs' test.

Early Lyme Disease With 20-Day Regimen

Two multicenter trials assessed CEFTIN 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days' dosing.

Single-Dose Regimen For Uncomplicated Gonorrhea

In clinical trials using a single 1,000-mg dose of CEFTIN, 1,061 subjects were treated for uncomplicated gonorrhea. The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg CEFTIN in U.S. clinical trials.

Table 6: Adverse Reactions (≥1%) after Single-Dose Regimen with 1,000-mg CEFTIN Tablets for Uncomplicated Gonorrhea

Adverse Reaction CEFTIN
(n = 1,061)
Gastrointestinal disorders
Nausea/Vomiting 7%
Diarrhea 4%

The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of CEFTIN 1,000 mg for uncomplicated gonorrhea in U.S. clinical trials.

Infections and Infestations: Vaginal candidiasis.

Nervous System Disorders: Headache, dizziness, somnolence.

Cardiac Disorders: Tightness/pain in chest, tachycardia.

Gastrointestinal Disorders: Abdominal pain, dyspepsia.

Skin and Subcutaneous Tissue Disorders: Erythema, rash, pruritus.

Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction.

Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain.

Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge.

Oral Suspension

In clinical trials using multiple doses of CEFTIN, pediatric subjects (96.7% were younger than 12 years) were treated with CEFTIN (20 to 30 mg/kg/day divided twice daily up to a maximum dose of 500 or 1,000 mg/day, respectively). Eleven (1.2%) U.S. subjects discontinued medication due to adverse reactions. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. Thirteen (1.4%) U.S. pediatric subjects discontinued therapy due to the taste and/or problems with drug administration.

The adverse reactions in Table 7 are for U.S. subjects (n = 931) treated with CEFTIN in multiple-dose clinical trials.

Table 7: Adverse Reactions (>1%) after Multiple-Dose Regimens with CEFTIN for Oral Suspension

Adverse Reaction CEFTIN
(n = 931)
Gastrointestinal disorders
Diarrhea 9%
Dislike of taste 5%
Nausea/vomiting 3%
Skin and subcutaneous tissue disorders
Diaper rash 3%

The following adverse reactions occurred in less than 1% but greater than 0.1% of U.S. subjects (n = 931) treated with CEFTIN for oral suspension in multiple-dose clinical trials.

Infections and Infestations: Gastrointestinal infection, candidiasis, viral illness, upper respiratory infection, sinusitis, urinary tract infection.

Blood and Lymphatic System Disorders: Eosinophilia.

Psychiatric Disorders: Hyperactivity, irritable behavior.

Gastrointestinal Disorders: Abdominal pain, flatulence, ptyalism.

Skin and Subcutaneous Tissue Disorders: Rash.

Musculoskeletal and Connective Tissue Disorders: Joint swelling, arthralgia.

Reproductive System and Breast Disorders: Vaginal irritation.

General Disorders and Administration Site Conditions: Cough, fever.

Investigations: Elevated liver enzymes, positive Coombs' test.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CEFTIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders

Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia.

Gastrointestinal Disorders

Pseudomembranous colitis [see WARNINGS AND PRECAUTIONS].

Hepatobiliary Disorders

Hepatic impairment including hepatitis and cholestasis, jaundice.

Immune System Disorders

Anaphylaxis, serum sickness-like reaction.

Investigations

Increased prothrombin time.

Nervous System Disorders

Seizure, encephalopathy.

Renal and Urinary Disorders

Renal dysfunction.

Skin and Subcutaneous Tissue Disorders

Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

Read the entire FDA prescribing information for Ceftin (Cefuroxime Axetil)

Related Resources for Ceftin

Read the Ceftin User Reviews »

© Ceftin Patient Information is supplied by Cerner Multum, Inc. and Ceftin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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