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BACILLUS ANTHRACIS


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following adverse events have been reported spontaneously. Since these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reports included below are listed due to one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.
  • Blood and lymphatic system disorders
  • Lymphadenopathy
  • Gastrointestinal Disorders
  • Nausea
  • Immune system disorders
  • Allergic reactions (including anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction, and Stevens Johnson syndrome)
  • Nervous system disorders
  • Paresthesia syncope, dizziness, tremor, ulnar nerve neuropathy
  • Musculoskeletal, connective tissue, and bone disorders
  • Arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia
  • General disorders and administration site conditions
  • Malaise, pain, cellulitis, flu-like symptoms
  • Psychiatric disorders
  • Insomnia
  • Skin and Subcutaneous disorders
  • Pruritis, rash, urticaria
  • Vascular disorders
  • Flushing
  • Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
0
42912
Other ADRs
0
14117279

Odds Ratio = N/A

Drug Property Information



ATC Code(s): N/A
Active Ingredient:bacillus anthracis strain v770-np1-r antigens
Active Ingredient UNII:873OI62848
Drugbank ID:-
PubChem Compound:N/A
CAS Number:-
Dosage Form(s):injection, suspension
Route(s) Of Administrator:intramuscular; subcutaneous
Daily Dose:
Chemical Structure:
SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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