Ceftobiprole Medocaril Side Effects

Applies to ceftobiprole medocaril: intravenous powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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 (even if it occurs months after your last dose);

• seizures;

• muscle stiffness or twitching; or

• drowsiness, tiredness, confusion, thinking problems.

Common side effects may include:

• low potassium blood levels;

• anemia (low red blood cells);

• headache, nausea, vomiting, diarrhea;

• stomach pain, high blood pressure;

• fever, low white blood cell (WBC) counts;

• pain, swelling, burning, or irritation around the IV needle;

• abnormal liver and kidney function tests;

• altered sense of taste;

• sleep problems (insomnia);

• dizziness; or

• rash.

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 ceftobiprole medocaril: intravenous powder for injection.

General adverse events

The most common adverse reactions included nausea, vomiting, diarrhea, headache, infusion site reaction, dysgeusia, anemia, hypokalemia, increased hepatic enzymes, increased bilirubin, increased blood creatinine, hypertension, leukopenia, pyrexia, injection site reaction, rash, insomnia, abdominal pain, phlebitis, dizziness, and hypersensitivity (including urticaria, pruritic rash, and drug hypersensitivity).^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, phlebitis
• Frequency not reported: Thrombosis
• Postmarketing reports: Hypertension

Hypertension included hypertension, increased blood pressure, and hypertensive crisis.

Phlebitis included phlebitis and injection site phlebitis.

Dermatologic

• Common (1% to 10%): Rash, pruritus
• Frequency not reported: Angioedema, mucocutaneous fungal infections

Rash included rash, drug eruption, dermatitis, contact dermatitis, allergic dermatitis, pruritic rash, macular rash, papular rash, maculopapular rash, and generalized rash.

Gastrointestinal

• Very common (10% or more): Nausea (up to 11%)
• Common (1% to 10%): Vomiting, diarrhea, abdominal pain, dyspepsia
• Uncommon (0.1% to 1%): Clostridioides difficile colitis
• Frequency not reported: Dysphagia

Abdominal pain included upper abdominal pain, abdominal tenderness, abdominal discomfort, and abdominal pain.

C difficile colitis included pseudomembranous colitis.

Genitourinary

• Frequency not reported: Pollakiuria

Hematologic

• Very common (10% or more): Anemia
• Uncommon (0.1% to 1%): Eosinophilia, leukopenia, thrombocytosis, thrombocytopenia
• Frequency not reported: Prolonged prothrombin time
• Postmarketing reports: Agranulocytosis, aplastic anemia, hemorrhage, positive direct Coombs test

Anemia included anemia, decreased hemoglobin, hypochromic anemia, and normochromic normocytic anemia.

Leukopenia included leukopenia, decreased lymphocyte count, lymphopenia, neutropenia, decreased neutrophil count, and decreased WBC count.

Hepatic

• Common (1% to 10%): Increased hepatic enzyme, increased bilirubin
• Postmarketing reports: Hepatic dysfunction, cholestasis

Increased hepatic enzyme included increased AST, increased GGT, increased ALT, increased LDH, increased blood alkaline phosphatase, increased hepatic enzyme, increased transaminases, and increased liver function test.

Increased bilirubin included increased blood bilirubin and hyperbilirubinemia.

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reactions
• Uncommon (0.1% to 1%): Anaphylactic reactions
• Frequency not reported: Anaphylaxis, anaphylactic shock
• Postmarketing reports: Serum sickness-like reaction

Hypersensitivity reactions included urticaria, pruritic rash, and drug hypersensitivity.

Local

• Common (1% to 10%): Infusion site reactions, injection site reaction
• Frequency not reported: Infusion site pain

Infusion site reaction included injection site reaction and infusion related reaction.

Metabolic

• Common (1% to 10%): Hypokalemia, hyponatremia
• Uncommon (0.1% to 1%): Increased blood glucose
• Postmarketing reports: False-positive test for urinary glucose

Hypokalemia included decreased blood potassium.

Musculoskeletal

• Uncommon (0.1% to 1%): Muscle spasms

Nervous system

• Common (1% to 10%): Dysgeusia, headache, dizziness, somnolence, seizures
• Uncommon (0.1% to 1%): Convulsions
• Postmarketing reports: Myoclonus

Convulsions included seizure, epilepsy, generalized tonic-clonic seizure, myoclonic epilepsy, myoclonus, seizure-like phenomena, and status epilepticus.

Other

• Very common (10% or more): Increased mortality/death (up to 34%)
• Common (1% to 10%): Pyrexia, fungal infection
• Uncommon (0.1% to 1%): Peripheral edema, increased blood triglycerides
• Frequency not reported: Fatigue, chills, facial swelling, increased blood LDH
• Postmarketing reports: Drug fever

Pyrexia included hyperthermia and pyrexia.

Fungal infection included Candida infection, Candida sepsis, positive fungal test, oral candidiasis, vulvovaginal candidiasis, tinea pedis, vulvovaginal fungal infection, oral fungal infection, and cutaneous fungal infection.

In trials of adult patients with Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia, deaths occurred in 8.9%, 0.3%, and 2.9% of patients treated with this drug, respectively (vs 9.1%, 0.6%, and 2.8% of comparator-treated patients, respectively). In a trial of pediatric patients with community-acquired bacterial pneumonia, no deaths occurred in patients treated with this drug or comparator.

In a trial of adult patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP), deaths occurred in 22.8% of patients treated with this drug and 21.8% of patients treated with comparator). In this trial, increased mortality was observed in the subgroup of patients with VABP who were treated with this drug (34% vs 23.5% in comparator-treated patients); causality was not established. In general deaths were associated with complications of infection or underlying comorbidities. In the subgroup of patients with HABP, death occurred in 18.7% of patients treated with this drug and 18.7% of patients treated with comparator.

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Agitation
• Frequency not reported: Anxiety, irritability

Agitation included anxiety, panic attacks, and nightmares.

Renal

• Uncommon (0.1% to 1%): Renal failure, increased blood creatinine
• Postmarketing reports: Renal dysfunction, toxic nephropathy

Renal failure included potential interactions with nephrotoxic drugs.

Increased blood creatinine included acute kidney injury, increased blood creatinine, decreased renal CrCl, oliguria, and renal impairment.

Respiratory

• Uncommon (0.1% to 1%): Dyspnea, pharyngolaryngeal pain, asthma
• Frequency not reported: Bronchospasm, wheezing

Dyspnea included dyspnea and respiratory distress.

See also:

Further information

Ceftobiprole medocaril side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer