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

Applies to doripenem: intravenous powder for injection.

General

In 5 clinical trials, 1338 adult patients received this drug. The most common side effects were anemia, headache, nausea, diarrhea, rash, elevated hepatic enzymes, and phlebitis. During clinical studies, this drug was discontinued due to side effects in 4.1% of patients.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%)

Frequency not reported: Dizziness

Postmarketing reports: Seizure^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 12%), diarrhea (up to 12%)

Common (1% to 10%): Oral candidiasis

Uncommon (0.1% to 1%): Clostridium difficile colitis

Frequency not reported: Constipation, abdominal pain, dyspepsia^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Postmarketing reports: Anaphylaxis^[Ref]

Serious and sometimes fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactams.^[Ref]

Hematologic

Common (1% to 10%): Anemia

Postmarketing reports: Neutropenia, leukopenia, thrombocytopenia^[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis

Frequency not reported: Atrial fibrillation, atrial flutter, hypertension, hypotension^[Ref]

Hepatic

Elevated hepatic enzymes also included ALT or AST at or below the upper limit of normal (ULN) at baseline increasing to greater than 5 times ULN at end of therapy.^[Ref]

Common (1% to 10%): Elevated hepatic enzymes (includes elevated ALT, elevated AST, elevated transaminases)

Frequency not reported: Cholestasis^[Ref]

Dermatologic

The incidence of rash was higher in patients receiving doses greater than the approved dose compared to those receiving the approved dose. The rash resolved within 10 days after this drug was stopped.

Serious skin reactions have been reported with beta-lactams.^[Ref]

Common (1% to 10%): Rash, pruritus

Frequency not reported: Erythema, macular/papular eruptions, bullous dermatitis, urticaria, erythema multiforme, allergic dermatitis, decubitus ulcer

Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Genitourinary

Common (1% to 10%): Vulvomycotic infection

Frequency not reported: Urinary tract infection, asymptomatic bacteriuria^[Ref]

Respiratory

Pneumonitis has been reported when this drug was administered via inhalation.^[Ref]

Frequency not reported: Pneumonitis, pneumonia, pleural effusion, dyspnea

Postmarketing reports: Interstitial pneumonia^[Ref]

Renal

Postmarketing reports: Renal impairment/renal failure^[Ref]

Metabolic

Frequency not reported: Hypokalemia^[Ref]

Other

Frequency not reported: Pyrexia, peripheral edema^[Ref]

Psychiatric

Frequency not reported: Insomnia, anxiety^[Ref]