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TheraCys Side Effects

Generic name: bcg

Medically reviewed by Drugs.com. Last updated on Apr 10, 2021.

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

For the Consumer

Applies to bcg: intravesical powder for suspension

Warning

Intravesical route (Powder for Suspension; Powder for Solution)

Bacillus of Calmette and Guérin (BCG) infections have been reported in health care workers and in patients because of exposure to the vaccine during preparation and administration. Serious and fatal disseminated BCG infections have occurred with intravesical administration. Manifestations of disseminated infection may not develop for months or years after therapy as BCG may persist in the urinary tract for several months after treatment. TheraCys® and TICE® BCG contain live attenuated mycobacteria and because of the potential risk for transmission, they should be prepared, handled, and disposed of as a biohazard material.

Side effects requiring immediate medical attention

Along with its needed effects, bcg (the active ingredient contained in TheraCys) 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 as soon as possible if any of the following side effects occur while taking bcg:

More common

  • Blood in urine
  • fever and chills
  • frequent urge to urinate
  • increased frequency of urination
  • joint pain
  • nausea and vomiting
  • painful urination (severe or continuing)

Rare

Side effects not requiring immediate medical attention

Some side effects of bcg 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

  • Burning during first urination after treatment

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:

  • Cough
  • fever

For Healthcare Professionals

Applies to bcg: intravesical powder for reconstitution, percutaneous powder for injection

Genitourinary

Very common (10% or more): Dysuria (60%), increased urgency/frequency (40%), drug induced cystitis (30%), bacterial cystitis (27%), hematuria (27%), pollakiuria

Common (1% to 10%): Urinary tract infection, urinary incontinence, micturition urgency, urine analysis abnormal, bladder cramps, hemorrhage cystitis, urinary retention

Uncommon (0.1% to 1%): Bladder constriction, pyuria, ureteric obstruction

Rare (0.01 to less than 0.1%): Epididymitis

Very rare (less than 0.01%): Orchitis, balanoposthitis, prostatitis, vulvovaginal discomfort[Ref]

Other

Very common (10% or more): Malaise/fatigue/lethargy (19%), fever without infection (13%), influenza-like illness, pyrexia, rigors

Common (1% to 10%): Chills

Very rare (less than 0.01%): Reiter's syndrome, chest pain, peripheral edema, prostate specific antigen increased, weight decreased, BCG osteomyelitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, vertigo

Very rare (less than 0.01%): Dysesthesia, hyperesthesia, paresthesia, somnolence, headache[Ref]

Hematologic

Common (1% to 10%): Anemia, leukopenia

Uncommon (0.1% to 1%): Pancytopenia, thrombocytopenia

Very rare (less than 0.01%): Lymphadenopathy

Frequency not reported: Axillary or cervical lymphadenopathy, regional suppurative lymphadenitis[Ref]

Gastrointestinal

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

Very rare (less than 0.01%): Dyspepsia, flatulence[Ref]

Immunologic

Common (1% to 10%): Infection

Uncommon (0.1% to 1%): Tuberculosis infections

Very rare (less than 0.01%): Disseminated BCG infection[Ref]

Dermatologic

Common (1% to 10%): Skin rash, sweats

Uncommon (0.1% to 1%): Rashes, eruptions and exanthema not otherwise classified

Very rare (less than 0.01%): Lupus vulgaris, alopecia, hyperhidrosis, granuloma[Ref]

Respiratory

Common (1% to 10%): Pneumonitis

Rare (0.01% to 0.1%): Cough

Very rare (less than 0.01%): Pharyngitis, bronchitis, dyspnea, rhinitis[Ref]

Renal

Very rare (less than 0.01%): Renal failure acute[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, arthritis, myalgia

Very rare (less than 0.01%): Back pain[Ref]

Hypersensitivity

Common (1% to 10%): Allergic symptoms[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatitis, hepatic enzyme increased[Ref]

Cardiovascular

Very rare (less than 0.01%): Hypotension[Ref]

Psychiatric

Very rare (less than 0.01%): Confusional state[Ref]

Metabolic

Very rare (less than 0.01%): Anorexia[Ref]

Ocular

Very rare (less than 0.01%): Conjunctivitis[Ref]

Local

Frequency not reported: Injection site reactions: Induration, pustule formation, ulceration, caseous lesions, purulent draining, tenderness, itching, papules[Ref]

Frequently asked questions

References

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

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

3. "Product Information. Tice BCG Vaccine (BCG (BCG vaccine))." Organon, West Orange, NJ.

4. "Product Information. BCG Vaccine (BCG)." Organon Pharmaceuticals, West Orange, 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.