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Applies to doripenem: intravenous powder for suspension
Along with its needed effects, doripenem may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking doripenem:
Incidence not known
Some side effects of doripenem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to doripenem: intravenous powder for injection
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.
Very common (10% or more): Headache (up to 16%)
Frequency not reported: Dizziness
Postmarketing reports: Seizure
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
Frequency not reported: Hypersensitivity reactions
Postmarketing reports: Anaphylaxis
Serious and sometimes fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactams.
Common (1% to 10%): Anemia
Postmarketing reports: Neutropenia, leukopenia, thrombocytopenia
Common (1% to 10%): Phlebitis
Frequency not reported: Atrial fibrillation, atrial flutter, hypertension, hypotension
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.
Common (1% to 10%): Elevated hepatic enzymes (includes elevated ALT, elevated AST, elevated transaminases)
Frequency not reported: Cholestasis
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
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.
Common (1% to 10%): Vulvomycotic infection
Frequency not reported: Urinary tract infection, asymptomatic bacteriuria
Frequency not reported: Pneumonitis, pneumonia, pleural effusion, dyspnea
Postmarketing reports: Interstitial pneumonia
Pneumonitis has been reported when this drug was administered via inhalation.
Postmarketing reports: Renal impairment/renal failure
Frequency not reported: Hypokalemia
Frequency not reported: Pyrexia, peripheral edema
Frequency not reported: Insomnia, anxiety
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