ADVERSE REACTIONS
Body as a Whole
The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (see
WARNINGS). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk or vaccines. Two types of allergic reactions to penicillins are noted clinically, immediate and delayed.
Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. Such immediate anaphylactic reactions are very rare (see
WARNINGS) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever.
Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy. Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.
Local Reactions
Pain, swelling, inflammation, phlebitis, thrombophlebitis, and occasional skin sloughing at the injection site have occurred with intravenous administration of nafcillin. (See
DOSAGE AND ADMINISTRATION.) Severe tissue necrosis with sloughing secondary to subcutaneous extravasation of nafcillin has been reported.
Nervous System Reactions
Neurotoxic reactions similar to those observed with penicillin G could occur with large intravenous or intraventricular doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction. (See
PRECAUTIONS).
Urogenital Reactions
Renal tubular damage and interstitial nephritis have been associated infrequently with the administration of nafcillin. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency.
Gastrointestinal Reactions
Pseudomembranous colitis has been reported with the use of nafcillin. The onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see
WARNINGS).
Metabolic Reactions
Agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of nafcillin.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov
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REPORTS OF SUSPECTED NAFCILLIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Nafcillin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Nafcillin side effects / adverse reactions in 77 year old male
Reported by a pharmacist from United States on 2011-10-25
Patient: 77 year old male weighing 50.6 kg (111.3 pounds)
Reactions: Exophthalmos, Hypokalaemia, Urinary Casts, Respiratory Failure, Sepsis, Haemolytic Anaemia, Renal Tubular Necrosis, Eye Disorder, Hypovolaemia, Renal Failure Acute
Suspect drug(s):
Nafcillin
Possible Nafcillin side effects / adverse reactions in 53 year old male
Reported by a pharmacist from United States on 2011-11-18
Patient: 53 year old male weighing 93.3 kg (205.3 pounds)
Reactions: Renal Impairment, Dehydration
Suspect drug(s):
Nafcillin
Possible Nafcillin side effects / adverse reactions in 52 year old male
Reported by a physician from United States on 2012-02-06
Patient: 52 year old male
Reactions: Nelson's Syndrome
Suspect drug(s):
Cubicin
Indication: Staphylococcal Bacteraemia
Cubicin
Indication: Cellulitis
Nafcillin
Indication: Cellulitis
Nafcillin
Indication: Staphylococcal Bacteraemia
Other drugs received by patient: Furosemide; Potassium Chloride; Spironolactone; Insulin; Warfarin Sodium; Metformin HCL; Stool Softener; Metoprolol; Hydralazine HCL; Risedronate Sodium; Acetaminophen and Oxycodone HCL; Valsartan; Amlodipine; Acetylsalicylic Acid SRT
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