Doripenem Side Effects

Some side effects of doripenem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to doripenem: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking doripenem: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• diarrhea that is watery or bloody; or

• severe itching or skin rash.

Other 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

The safety report of doripenem is based on 853 adult patients receiving the indicated dosing regimen during three phase 3 clinical trials. The most common side effects (5% or greater) reported with doripenem were headache, nausea, diarrhea, rash, and phlebitis. During clinical studies, side effects leading to discontinuations were nausea (0.2%), rash (0.1%), and vulvomycotic infection (0.1%).

Gastrointestinal

Gastrointestinal side effects have included nausea (4% to 12%), diarrhea (6% to 11%), and Clostridium difficile colitis (less than 1%).

Hypersensitivity

Hypersensitivity side effects have included rash (1% to 5%; includes reactions reported as allergic and bullous dermatitis, urticaria, and erythema multiforme) and serious hypersensitivity reactions (less than 1%). Anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (4% to 16%). Seizure has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (2% to 10%), regardless of causality. Neutropenia, leukopenia, and thrombocytopenia have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included phlebitis (4% to 8%).

Dermatologic

Dermatologic side effects have included pruritus (less than 1% to 3%) and rash (1% to 5%; includes reactions reported as erythema and macular/papular eruptions).

Immunologic

Immunologic side effects have included vulvomycotic infection (1% to 2%) and oral candidiasis (1%).

Hepatic

Hepatic side effects have included elevated hepatic enzymes (1% to 2%), including reactions reported as elevated alanine transaminase, elevated aspartate transaminase, and elevated transaminases.

Respiratory

Respiratory side effects have included pneumonitis when doripenem was administered via inhalation. Interstitial pneumonia has been reported during postmarketing experience.

Renal

Renal side effects have included renal impairment/renal failure (1% or less), regardless of causality.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.