Doripenem Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

Applies to doripenem: 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; or

• severe itching or skin rash.

Common side effects may include:

• headache;

• diarrhea, nausea;

• vaginal itching or discharge;

• mild rash; or

• pain, swelling, or redness where the medicine was injected.

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 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

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

Postmarketing reports: Interstitial pneumonia^[Ref]

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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