TheraCys Side Effects

Generic name: bcg

Medically reviewed by Drugs.com. Last updated on May 26, 2024.

Note: This document provides detailed information about TheraCys Side Effects associated with bcg. Some dosage forms listed on this page may not apply specifically to the brand name TheraCys.

Applies to bcg: intravesical powder for suspension.

Important warnings This medicine can cause some serious health issues

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.

Thera. Cys® 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.

Serious side effects of TheraCys

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 side effects

• 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

• cough
• skin rash

Other side effects of TheraCys

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 side effects

• 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 adverse events

• 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

• Does the BCG vaccine for TB help with COVID-19 (coronavirus)?

Further information

TheraCys side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer