Injection site irritation

Other adverse reactions associated with penicillin are hematopoietic changes such as anemia, thrombocytopenia (low platelet count), leukopenia (low white blood cell count), and bone marrow depression. When penicillin is given orally, glossitis (inflammation of the tongue), stomatitis (inflammation of die mouth), dry mouth, gastritis, nausea, vomiting, and abdominal pain occur. When penicillin is given intramuscularly (IM), there may be pain at die injection site Irritation of the vein and phlebitis (inflammation of a vein) may occur witii intravenous (IV) administration. 

Judicious selection of excipients for parenteral dosage forms is critical due to their systemic administration.106107 Excipients of a parenteral dosage form may have a significant effect on product safety including injection site irritation or pain. Permissible excipients for parenteral dosage forms are far less than those for oral dosage forms. 

Local injection site irritation studies would be expected with these types of products because they are almost always given by injection. 

Zimmerman T+, Clin Drug Invest 21, 527 (58%) Injection-site irritation... 

Injection-site irritation Injection-site pain (< 1%)... 

Injection-site calcification (1987) Goa KL +, Drugs 33,242 Injection-site irritation... 

Untoward vaccine effects are variable, manifesting from injection site irritation, fever, and irritability to encephalopathy, paralysis, and even death. - " " Reporting of certain vaccine adverse events to the Vaccine Adverse Event Reporting System (VAERS) is mandatory. VAERS was established by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to facilitate the process of gathering postmarketing surveillance data on vaccine-related adverse events. VAERS reports record adverse events temporally but not necessarily eausally associated with vaccination. 

Nineteen patients experienced adverse events in the deferoxamine cohort of a prospective, randomised, phase II study comparing deferoxamine with deferasirox in sickle cell disease patients (n=68) [50 ]. The side effects were diarrhoea, nausea, abdominal pain, injection site irritation and injection site pain (all with an incidence of 3.6%). 

---