Note: This document contains side effect information about oritavancin. Some dosage forms listed on this page may not apply to the brand name Orbactiv.
Applies to oritavancin: intravenous powder for solution.
Serious side effects of Orbactiv
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
- Accumulation of pus
- changes in skin color
- dry, red, hot, or irritated skin
- fast, pounding, or irregular heartbeat or pulse
- fever
- pain, swelling, or tenderness in the skin
- swollen, red, tender area of infection
Less common
- Anxiety
- black, tarry stools
- blistering, peeling, or loosening of the skin
- blurred vision
- chest pain or tightness
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- difficulty in moving
- dizziness
- headache
- hives, itching skin, or rash
- increase in bone pain
- increased hunger
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back, side, or stomach pain
- muscle aches, cramps, pains, or stiffness
- nervousness
- nightmares
- noisy breathing
- painful or difficult urination
- pale skin
- red, irritated eyes
- redness or soreness of the skin
- seizures
- shakiness
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the eyelids, face, lips, hands, feet, ankles, or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Stomach cramps or tenderness
- watery and severe diarrhea, which may also be bloody
Other side effects of Orbactiv
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
- Hard lump, pain, redness, or pale skin at the site of injection
- nausea or vomiting
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
Common (1% to 10%): Infusion site erythema, infusion site phlebitis, infusion site reactions[Ref]
Infusion site reactions included extravasation, induration, infusion site erythema, infusion site phlebitis, peripheral edema, pruritus, and rash.[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]
