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. 

Mild pain with transient burning/ Apply to all lesions q3h stinging, pruritus, rash, vulvitis, 6 times daily for 1 wk edema or pain at application site Irritation at application site, Apply q2h for 4 d... 

Average score per site Irritancy grade 0.0 to 0.4 None... 

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. 

In an open comparative study of androgenetic alopecia in 90 men oral finasteride (1 mg/day for 12 months n = 65) was compared with 5% topical minoxidil solution twice daily (n = 25) (22). The cure rates were 80% for oral finasteride and 52% for topical minoxidil. The adverse effects were all mild, and did not lead to withdrawal of treatment. Of the 65 men given oral finasteride, six had loss of libido, and one had an increase in body hair at other sites irritation of the scalp was seen in one of those who used minoxidil. These adverse events disappeared as soon as the treatment was withdrawn. The laboratory data did not show any statistically or clinically significant changes from baseline values to the endpoint, except for the serum total testosterone concentration, which was increased, and free testosterone and serum prostate-specific antigen in the finasteride group which were reduced from baseline values. 

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. 

A randomised double-blind placebo-controlled trial [33 ] investigating ketamine in the management of cancer pain demonstrated no improvement with escalating doses of ketamine (100, 300 and 500 mg) delivered subcutaneously over 24 h. There was, however, a statistically significant increase in adverse events in the ketamine group. This included cognitive disturbances, dizziness, site irritation, somnolence and nausea. 

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%). 

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