Doribax Side Effects

Generic Name: doripenem

Please note - some side effects for Doribax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Doribax - for the Consumer

Doribax

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Doribax:

Headache; mild diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; unusual tiredness or weakness; unusual vaginal odor, itching, or discharge.

Doribax Side Effects - for the Professional

Doribax

Most common adverse reactions (≥ 5%) are headache, nausea, diarrhea, rash and phlebitis.

Side Effects by Body System

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 and leukopenia 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.

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