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

Applies to vancomycin: oral capsule, oral powder for solution, oral powder for suspension. Other dosage forms:

• intravenous powder for solution, intravenous solution

Serious side effects of Firvanq

Along with its needed effects, vancomycin (the active ingredient contained in Firvanq) 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 immediately if any of the following side effects occur while taking vancomycin:

More common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• decreased urine
• difficult, burning, or painful urination
• dry mouth
• fever
• frequent urge to urinate
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• seizures
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Less common

• Change in the frequency of urination or amount of urine
• drowsiness
• trouble breathing
• weakness

Rare

• Hives, skin rash
• redness or other discoloration of the skin
• scaling or welting of the skin

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blurred vision
• chest pain or tightness
• chills
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• feeling of constant movement of self or surroundings
• feeling of fullness in the ears
• hearing loss
• itching
• joint or muscle pain
• loss of balance
• lower back or side pain
• pale skin
• pinpoint red spots on the skin
• 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
• ringing or buzzing in the ears
• sensation of spinning
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swollen glands
• unusual bleeding or bruising

Other side effects of Firvanq

Some side effects of vancomycin 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

• Back pain
• bitter or unpleasant taste
• excess air or gas in the stomach or bowels
• headache
• mouth irritation
• passing gas
• stomach pain

Incidence not known

• Depression
• difficulty having a bowel movement
• trouble sleeping

For Healthcare Professionals

Applies to vancomycin: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral powder for reconstitution, oral solution.

General

The most commonly reported side effects include nausea, abdominal pain, and hypokalemia.^[Ref]

Gastrointestinal

Chemical peritonitis occurred with intraperitoneal administration.

Mild gastrointestinal tract disturbances occurred with oral administration.^[Ref]

Very common (10% or more): Nausea (up to 17%), abdominal pain (up to 15%)

Common (1% to 10%): Vomiting, diarrhea, flatulence

Uncommon (0.1% to 1%): Mild gastrointestinal tract disturbances

Very rare (less than 0.01%): Pseudomembranous enterocolitis/colitis

Frequency not reported: Chemical peritonitis, constipation, indigestion, stomachache^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 13%)^[Ref]

Dermatologic

Common (1% to 10%): Exanthema, pruritus, vancomycin (the active ingredient contained in Firvanq) infusion reaction, redness of the face/upper arms, urticaria

Uncommon (0.1% to 1%): Erythema, itch

Rare (0.01% to 0.1%): Toxic epidermal necrolysis

Very rare (less than 0.01%): Exfoliative dermatitis, linear IgA bullous dermatosis, Lyell's syndrome, Stevens-Johnson syndrome

Frequency not reported: Acute generalized exanthematous pustulosis (AGEP), erythematous macular rash with intense pruritus over face/neck/upper body, rash, red neck^[Ref]

Cardiovascular

Common (1% to 10%): Decrease in blood pressure, flushing of the upper body, peripheral edema, phlebitis

Uncommon (0.1% to 1%): Thrombophlebitis

Rare (0.01% to 0.1%): Vasculitis

Very rare (less than 0.01%): Cardiac arrest

Frequency not reported: Bradycardia, cardiogenic shock, generalized flushing, hypotension, palpitations, substernal pressure, tachycardia

Postmarketing reports: Chest pain^[Ref]

Hypotension, bradycardia, cardiogenic shock, and cardiac arrest have occurred with rapid bolus administration.^[Ref]

Renal

Renal failure was most commonly characterized by increased serum creatinine levels or BUN concentrations.

Azotemia usually resolved upon discontinuation of treatment.^[Ref]

Common (1% to 10%): Increased serum creatinine, increased serum urea, nephrotoxicity, renal insufficiency

Rare (0.01% to 0.1%): Acute renal failure, interstitial nephritis

Frequency not reported: Acute kidney injury, Acute tubular necrosis, azotemia, blood urea nitrogen (BUN) concentrations increased, uremia, transient increased urea^[Ref]

Other

Common (1% to 10%): Fatigue, mucosal inflammation, pyrexia

Uncommon (0.1% to 1%): Chills, fever, pain, permanent hearing loss, transient hearing loss

Rare (0.01% to 0.1%): Drug fever, ototoxicity, rigors, shivering, tinnitus^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, stridor

Frequency not reported: Wheezing^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Rare (0.01% to 0.1%): Back and chest muscle pain and spasm^[Ref]

Nervous system

Common (1% to 10%): Headache

Rare (0.01% to 0.1%): Dizziness, vertigo^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Frequency not reported: Granular urinary casts^[Ref]

Hematologic

Uncommon (0.1% to 1%): Eosinophilia,

Rare (0.01% to 0.1%): Agranulocytosis, leukopenia, pancytopenia, reversible agranulocytosis, reversible neutropenia, thrombocytopenia

Frequency not reported: Anemia^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylaxis, hypersensitivity reactions

Frequency not reported: Anaphylactoid reaction^[Ref]

Immunologic

Rare (0.01% to 0.1%): Superinfection

Frequency not reported: Drug rash with eosinophilia and systemic symptoms (DRESS), non-susceptible organism overgrowth^[Ref]

Local

Frequency not reported: Injection site inflammation, injection site pruritus, necrosis, tissue irritation^[Ref]

Ocular

HORV occurred in patients given this drug via intracameral or intravitreal route during/after cataract surgery.^[Ref]

Frequency not reported: Hemorrhagic occlusive retinal vasculitis (HORV), permanent vision loss^[Ref]

Psychiatric

Frequency not reported: Depression, insomnia^[Ref]

Hepatic

Frequency not reported: Transaminase elevations^[Ref]