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Tice BCG Side Effects

Generic Name: bcg

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 Tice BCG.

In Summary

Common side effects of Tice BCG include: urinary tract infection, detrusor hyperreflexia of bladder, fever, hematuria, urinary frequency, urinary urgency, vomiting, chills, and malaise. Other side effects include: arthralgia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to bcg: intradermal powder for solution

Along with its needed effects, bcg (the active ingredient contained in Tice BCG) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

More common
  • Accumulation of pus
  • peeling or scaling of the skin
  • sores at place of injection
  • sores at different sites of the skin
  • swollen lymph glands
Rare

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]

References

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

2. Cerner Multum, Inc. "Australian Product Information." 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.

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