Oxacillin (Oxacillin Sodium) - Side Effects and Adverse Reactions

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 and vaccines.

Two types of allergic reactions to penicillin 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.

Nervous System Reactions

Neurotoxic reactions similar to those observed with penicillin G may occur with large intravenous doses of oxacillin especially in patients with renal insufficiency.

Urogenital Reactions

Renal tubular damage and interstitial nephritis have been associated infrequently with the administration of oxacillin. 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 oxacillin. 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 methicillin sodium, nafcillin, oxacillin, and cloxacillin. Hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of oxacillin and cloxacillin.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

REPORTS OF SUSPECTED OXACILLIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Oxacillin side effects / adverse reactions in 42 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-04

Patient: 42 year old male

Reactions: Agitation, Aggression

Adverse event resulted in: hospitalization

Suspect drug(s):
Zovirax
    Dosage: 1200 mg, tid
    Start date: 2011-09-10
    End date: 2011-09-13

Zovirax
    Dosage: 600 mg, tid
    Start date: 2011-09-13

Lovenox
    Dosage: unk
    Start date: 2011-09-05

Atarax
    Dosage: unk
    Start date: 2011-09-09

Diprosone
    Dosage: unk
    Start date: 2011-09-09

Nexium
    Dosage: unk
    Start date: 2011-09-05

Ciprofloxacin
    Dosage: unk
    Indication: Pneumonia
    Start date: 2011-09-11

Tramadol HCL
    Dosage: unk
    Start date: 2011-09-05
    End date: 2011-09-11

Piperacillin and Tazobactam
    Dosage: unk
    Start date: 2011-09-11

Zovirax
    Dosage: 600 mg, tid
    Start date: 2011-09-07
    End date: 2011-09-10

Oxacillin
    Dosage: unk
    Indication: Pneumonia
    Start date: 2011-09-11

Possible Oxacillin side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10

Patient: 56 year old female

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Clindamycin HCL
    Dosage: 300 mg, 3x/day
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-08-01

Levofloxacin
    Dosage: 700 mg daily
    Administration route: Oral
    End date: 2011-08-05

Oxacillin
    Dosage: unk
    Start date: 2011-08-01
    End date: 2011-08-08

Other drugs received by patient: Nexium

Possible Oxacillin side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-12

Patient: 56 year old female

Reactions: Pancytopenia, Thrombocytopenia, Septic Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Oxacillin
    Start date: 2011-06-01
    End date: 2011-06-01

Clindamycin HCL
    Administration route: Oral
    Indication: Sepsis
    Start date: 2011-06-01
    End date: 2011-08-01

Oxacillin
    Indication: Intervertebral Discitis
    Start date: 2011-06-01
    End date: 2011-06-01

Oxacillin
    Start date: 2011-06-01
    End date: 2011-06-01

Clindamycin HCL
    Administration route: Oral
    Indication: Endocarditis
    Start date: 2011-06-01
    End date: 2011-08-01

Oxacillin
    Indication: Endocarditis
    Start date: 2011-08-01
    End date: 2011-08-05

Oxacillin
    Indication: Sepsis
    Start date: 2011-08-01
    End date: 2011-08-05

Clindamycin HCL
    Administration route: Oral
    Indication: Intervertebral Discitis
    Start date: 2011-06-01
    End date: 2011-08-01

Levofloxacin
    Administration route: Oral
    Indication: Intervertebral Discitis
    End date: 2011-08-05

Levofloxacin
    Administration route: Oral
    Indication: Endocarditis
    End date: 2011-08-05

Levofloxacin
    Administration route: Oral
    Indication: Sepsis
    End date: 2011-08-05

Oxacillin
    Start date: 2011-08-01
    End date: 2011-08-05

Other drugs received by patient: Gentamicin; Nexium; Piperacillin and Tazobactam