Side Effects of Ceftin (cefuroxime)

Ceftin (cefuroxime) is a cephalosporin antibiotic used to treat infections of the middle ear, sinuses, skin, tonsils, and throat, and to treat laryngitis, bronchitis, pneumonia, urinary tract infections, gonorrhea, COPD, and early Lyme disease. 

Cephalosporins stop or slow the growth of bacterial cells by preventing bacteria from forming the cell wall that surrounds each cell. The cell wall protects bacteria from the external environment and keeps the contents of the cell together. Without a cell wall, bacteria are not able to survive. 

Ceftin is effective against a wide variety of bacteria, such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, E. coli, N. gonorrhea, and many others. 

Common side effects of Ceftin include

• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• headache,
• rash,
• hives,
• vaginitis, and
• mouth ulcers.

Serious side effects of Ceftin include

• allergic reactions (sometimes even anaphylaxis),
• severe skin reactions,
• anemia,
• seizures, and
• Clostridium difficile-associated diarrhea, which may range in severity from mild diarrhea to fatal pseudomembranous colitis.

Drug interactions of Ceftin include probenecid, which increases the concentration of Ceftin in the blood. Drugs that reduce acidity in the stomach (for example, antacids, H2-blockers, proton pump inhibitors) may reduce absorption of Ceftin. 

Cephalosporins including Ceftin are usually considered safe for use during pregnancy. 

Ceftin is excreted in breast milk and may cause adverse effects in the infant. Consult your doctor before breastfeeding. 

Cefuroxime is generally well tolerated, and side effects are usually transient. Commonly reported side effects are:

• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• headache,
• rash,
• hives,
• vaginitis, and
• mouth ulcers.

Other important side effects include:

• Allergic reactions,
• severe skin reactions,
• anemia, and
• seizures.

Since cefuroxime is chemically related to penicillin, patients allergic to penicillin may develop an allergic reaction (sometimes even anaphylaxis) to cefuroxime. Cefuroxime like other antibiotics can alter the colon's normal bacteria, leading to overgrowth of a bacterium called Clostridium difficile.

Overgrowth of this bacterium leads to the release of toxins that contribute to the development of Clostridium difficile-associated diarrhea, which may range in severity from mild diarrhea to fatal pseudomembranous colitis.

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 prescribing information).

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

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

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

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.

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.

Oral Contraceptives

• Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
• Counsel patients to consider alternate supplementary (non-hormonal) contraceptive measures during treatment.

Drugs That Reduce Gastric Acidity

• Drugs that reduce gastric acidity may result in a lower bioavailability of Ceftin compared with administration in the fasting state.
• Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of Ceftin when administered in the postprandial state.
• Administer Ceftin at least 1 hour before or 2 hours after administration of short-acting antacids. Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.

Probenecid

• Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime.
• Coadministration of probenecid with cefuroxime axetil is not recommended.

Drug/Laboratory Test Interactions

• A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests for glycosuria.
• As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil.
• The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.