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Doripenem Side Effects

For the Consumer

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:

More common
  • Bluish color
  • diarrhea
  • pain, tenderness, or swelling of the foot or leg
  • pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach cramps, pain, or tenderness
  • bloody urine
  • decreased frequency or amount of urine
  • fever
  • increased blood pressure
  • increased thirst
  • itching or pain of the vagina or genital area
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • sore mouth or tongue
  • swelling of the face, fingers, or lower legs
  • thick, white vaginal discharge with mild or no odor
  • troubled breathing
  • watery and severe diarrhea, which may also be bloody
  • weight gain
  • white patches in the mouth or on the tongue
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • difficulty with swallowing or sore throat
  • dizziness
  • fast heartbeat
  • itching
  • joint or muscle pain
  • loss of bladder control
  • muscle spasm or jerking of extremities
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin rash or hives
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • tightness in the chest

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:

More common

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

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. "Doripenem (Doribax)--a new parenteral carbapenem." Med Lett Drugs Ther 50 (2008): 5-7

2. Chastre J, Wunderink R, Prokocimer P, Lee M, Kaniga K, Friedland I "Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study." Crit Care Med 36 (2008): 1089-96

3. "Product Information. Doribax (doripenem)." Ortho McNeil Pharmaceutical, Raritan, NJ.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Doripenem (doribax)--a new parenteral carbapenem." Obstet Gynecol 111 (2008): 1206-7

6. Cerner Multum, Inc "Malaysia product information." O 0 (2015):

7. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

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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