TRAXONE Inj. is generally well tolerated. During the use of TRAXONE Inj. the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed.
Systemic Side Effects: Gastrointestinal Complaints (about 2% of cases): Loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.
Hematological Changes (about 2%): Eosinophilia, leucopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
Skin Reactions (about 1 %): Exanthema, allergic dermatitis, pruritus, urticaria, edema and erythema multiforme. Other rare side effects were headache and dizziness, increase in liver enzymes, gallbladder sludge, oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactic or anaphylactoid reactions. Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects.
Local Side Effects: In rare cases, phlebitis reactions occurred after I.V administration. These may be prevented by slow (2-4 min) injection of the substance, I.M. Injection without lidocaine solution is painful.