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Orbactiv Side Effects

Generic Name: oritavancin

Note: This document contains side effect information about oritavancin. Some of the dosage forms listed on this page may not apply to the brand name Orbactiv.

For the Consumer

Applies to oritavancin: intravenous powder for solution

Along with its needed effects, oritavancin (the active ingredient contained in Orbactiv) 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 oritavancin:

Less Common

  • Changes in skin color
  • dry, red, hot, or irritated skin
  • fast, pounding, or irregular heartbeat or pulse
  • pain, swelling, or tenderness in the skin

Less Common or Rare

  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • fever
  • hives, itching skin, or rash
  • increase in bone pain
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness, soreness, or itching skin
  • sores, welting, or blisters
  • swelling of the eyelids, face, lips, hands, or feet
  • swollen glands
  • tightness in the chest
  • unusual bleeding or bruising

Incidence Not Known

  • Abdominal or stomach tenderness
  • severe abdominal or stomach cramps and pain
  • watery and severe diarrhea, which may also be bloody

Some side effects of oritavancin 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:

Less Common or Rare

For Healthcare Professionals

Applies to oritavancin: intravenous powder for injection

General

In pooled clinical trials, serious side effects were reported in 5.8% of patients treated with this drug (compared to 5.9% treated with vancomycin). Cellulitis was the serious side effect reported most often with both drugs.

This drug was discontinued due to side effects in 3.7% of patients, most often due to cellulitis and osteomyelitis.

The most commonly reported side effects included nausea, headache, vomiting, limb and subcutaneous abscesses, and diarrhea.[Ref]

Dermatologic

Common (1% to 10%): Cellulitis, limb abscess, pruritus, rash, subcutaneous abscess, urticaria

Uncommon (0.1% to 1%): Erythema multiforme, leukocytoclastic vasculitis[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, nausea, vomiting

Frequency not reported: Clostridium difficile associated diarrhea[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function tests, increased ALT, increased AST

Uncommon (0.1% to 1%): Blood bilirubin increased

Frequency not reported: Increased total bilirubin[Ref]

Local

Infusion site reactions included extravasation, induration, infusion site erythema, infusion site phlebitis, peripheral edema, pruritus, and rash.[Ref]

Common (1% to 10%): Infusion site erythema, infusion site phlebitis, infusion site reactions[Ref]

Other

Common (1% to 10%): Extravasation, induration

Frequency not reported: Infusion related reactions[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, tachycardia

Uncommon (0.1% to 1%): Flushing[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Eosinophilia, thrombocytopenia[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Osteomyelitis, tenosynovitis[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Angioedema, hypersensitivity/hypersensitivity reactions[Ref]

Respiratory

Uncommon (0.1% to 1%): Bronchospasm, wheezing[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperuricemia, hypoglycemia[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Orbactiv (oritavancin)." The Medicines Company, Parsippany, NJ.

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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