Doribax Side Effects
Generic name: doripenem
Medically reviewed by Drugs.com. Last updated on Dec 26, 2024.
Note: This document provides detailed information about Doribax Side Effects associated with doripenem. Some dosage forms listed on this page may not apply specifically to the brand name Doribax.
Applies to doripenem: intravenous powder for injection.
Important warnings
This medicine can cause some serious health issues
You should not receive this medicine if you are allergic to doripenem, ertapenem (Invanz), imipenem (Primaxin), or meropenem (Merrem).
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:
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severe stomach pain;
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diarrhea that is watery or bloody; or
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severe itching or skin rash.
Common side effects may include:
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headache;
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diarrhea, nausea;
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vaginal itching or discharge;
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mild rash; or
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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 adverse events
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
- Common (1% to 10%): Elevated hepatic enzymes (includes elevated ALT, elevated AST, elevated transaminases)
- Frequency not reported: Cholestasis[Ref]
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]
Dermatologic
- 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]
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]
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]
References
1. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
2. (2007) "Product Information. Doribax (doripenem)." Ortho McNeil Pharmaceutical
3. (2008) "Doripenem (Doribax)--a new parenteral carbapenem." Med Lett Drugs Ther, 50, p. 5-7
4. Cerner Multum, Inc. "Australian Product Information."
5. Chastre J, Wunderink R, Prokocimer P, Lee M, Kaniga K, Friedland I (2008) "Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study." Crit Care Med, 36, p. 1089-96
6. (2008) "Doripenem (doribax)--a new parenteral carbapenem." Obstet Gynecol, 111, p. 1206-7
7. Cerner Multum, Inc (2015) "Malaysia product information."
More about Doribax (doripenem)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: carbapenems
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Patient resources
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Further information
Doribax side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.