Doripenem Side Effects

Not all side effects for doripenem may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to doripenem: intravenous powder for suspension

In addition to its needed effects, some unwanted effects may be caused by doripenem. In the event that any of these side effects do occur, they may require 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 of the side effects that can occur with doripenem may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Headache

For Healthcare Professionals

Applies to doripenem: intravenous powder for injection

General

The safety report of doripenem is based on 1338 adult patients receiving the indicated dosing regimen. The most common side effects (5% or greater) reported with doripenem were anemia, headache, nausea, diarrhea, rash, elevated hepatic enzymes, and phlebitis. During clinical studies, side effects led to discontinuation of doripenem in 4.1% of patients.

Nervous system

Very common (10% or more): Headache (3% to 16%)
Postmarketing reports: Seizure

Gastrointestinal

Very common (10% or more): Nausea (4% to 12%), diarrhea (6% to 12%)
Common (1% to 10%): Oral candidiasis (1% to 3%)
Uncommon (0.1% to 1%): Clostridium difficile colitis (1% or less)

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (less than 1%)
Frequency not reported: Allergic dermatitis
Postmarketing reports: Anaphylaxis

Serious and sometimes fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactams.

Hematologic

Common (1% to 10%): Anemia (2% to 10%)
Postmarketing reports: Neutropenia, leukopenia, thrombocytopenia

Cardiovascular

Common (1% to 10%): Phlebitis (2% to 8%)

Hepatic

Common (1% to 10%): Elevated hepatic enzymes (includes elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated transaminases, ALT or AST at or below ULN at baseline increasing to greater than 5 times ULN at end of treatment; 2% to 7%)

Dermatologic

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 doripenem was stopped.

Serious skin reactions have been reported with beta-lactams.

Common (1% to 10%): Rash (1% to 6%), pruritus (1% to 3%)
Frequency not reported: Erythema, macular/papular eruptions, bullous dermatitis, urticaria, erythema multiforme
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

Genitourinary

Common (1% to 10%): Vulvomycotic infection (up to 2%)

Respiratory

Frequency not reported: Pneumonitis
Postmarketing reports: Interstitial pneumonia

Pneumonitis has been reported when doripenem was administered via inhalation.

Renal

Frequency not reported: Renal impairment/renal failure (regardless of causality)

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