Garamycin Side Effects

Generic Name: gentamicin,gentamicin sulfate

Please note - some side effects for Garamycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Garamycin - for the Consumer

Garamycin Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Seek medical attention right away if any of these SEVERE side effects occur when using Garamycin Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); clumsiness; decreased urination; dizziness or lightheadedness; feeling of a whirling motion; hearing loss; itching; muscle weakness; numbness or tingling; ringing or roaring in the ears; seizures; vaginal irritation or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

The most frequently reported adverse effects associated with gentamicin therapy are ototoxicity and nephrotoxicity. These forms of toxicity occur more frequently in patients who experience prolonged exposure to serum gentamicin trough concentrations of greater than 2 mcg/mL. Patients with renal insufficiency are at an increased risk of developing toxicity.

Renal

Renal side effects associated with gentamicin use have included nephrotoxicity. The overall incidence of aminoglycoside nephrotoxicity is 2% to 10%. Gentamicin nephrotoxicity occurs in two forms: acute renal failure (ARF), and a more gradual, transient, and reversible azotemia. Fanconi syndrome and Bartter-like syndrome have been reported.

Acute renal failure due to gentamicin is usually nonoliguric with an average rise in serum creatinine of 1 to 3 mg/dL. Renal function generally returns to baseline in 7 to 14 days. Rarely, gentamicin produces renal tubular acidosis and renal potassium and magnesium wasting. There is no relationship between acute renal failure and the daily dose of gentamicin, however, an increased incidence has been associated with a serum trough gentamicin concentration greater than 2 mcg/mL. It has been suggested that there is a correlation between the higher peak concentrations associated with once-daily dosing and a higher incidence of nephrotoxicity. Other predisposing factors include advanced age, preexisting renal insufficiency, dehydration, and concomitant use of other potentially nephrotoxic drugs.

Nervous system

The onset of ototoxicity may be asymptomatic or may manifest as dizziness, vertigo, ataxia, tinnitus, and roaring in the ears. High tone hearing loss is often an early symptom of auditory toxicity. It has been suggested that once-daily dosing of gentamicin is associated with a higher incidence of ototoxicity.

Other side effects possibly related to gentamicin have included lethargy, confusion, depression, headache, pseudotumor cerebri, and acute organic brain syndrome.

Nervous system side effects have included ototoxicity, which generally presents as loss of vestibular function secondary to hair cell damage, but may also be auditory. Ototoxicity is closely related to the development of renal impairment, and may be irreversible. Peripheral neuropathy or encephalopathy with numbness, skin tingling, muscle twitching, seizures, and myasthenia gravis-like syndrome have also been reported.

Intraventricular and intrathecal administration of gentamicin has rarely been associated with aseptic meningitis, transient hearing loss, and seizures. Neuromuscular side effects including ataxia, paresis and incontinence have been reported after large intrathecal doses (40 mg to 160 mg) of preservative-containing gentamicin. Concurrent administration of parenteral and intrathecal gentamicin has been associated with eighth nerve dysfunction, fever, convulsions, leg cramps, and increases in cerebrospinal fluid protein.

Musculoskeletal

Musculoskeletal side effects have rarely included neuromuscular blockade, which occurs most commonly in patients who are predisposed including patients with myasthenia gravis, hypocalcemia, and those receiving a concomitant neuromuscular blocking agent. Tetany and muscle weakness may be associated with gentamicin-induced hypomagnesemia, hypocalcemia, and hypokalemia. Joint pain has also been reported.

Respiratory

Respiratory side effects have included case reports of respiratory depression and respiratory arrest. Gentamicin has also been possibly associated with pulmonary fibrosis.

Hypersensitivity

Hypersensitivity reactions possibly associated with gentamicin have included anaphylactoid reactions and laryngeal edema. Suspected allergic reactions against gentamicin with sodium metabisulfite preservative have been reported.

Local

Local reactions have occasionally included pain at the injection site, and rarely subcutaneous atrophy or fat necrosis at the injection site. Reactions associated with intrathecal injections have included arachnoiditis and burning at the injection site.

Dermatologic

Dermatologic side effects possibly associated with gentamicin have included rash, itching, urticaria, generalized burning, and alopecia.

Hematologic

Hematologic side effects possibly related to gentamicin use have included anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts, thrombocytopenia, immunologic thrombocytopenia, and purpura.

Hepatic

Hepatic side effects possibly related to gentamicin use have included transient hepatomegaly, and increases in serum transaminase, serum LDH, and bilirubin.

Cardiovascular

Cardiovascular side effects possibly related to gentamicin have included hypotension and hypertension.

Gastrointestinal

Gastrointestinal side effects possibly related to gentamicin have included nausea, vomiting, weight loss, decreased appetite, increased salivation, and stomatitis.

Ocular

Ocular side effects have included case reports of retinal ischemia resulting in loss of visual acuity after inadvertent intraocular injection of massive doses of gentamicin.

Other

Other side effects possibly related to gentamicin have included transient splenomegaly and fever.

Other

Pyrogenic reactions with symptoms of shaking, chills, fever, rigors, tachycardia, and/or hypotension have been reported with intravenous gentamicin. These reactions generally occurred within 3 hours of administration and were believed to be due to once-daily gentamicin doses delivering sufficient endotoxin over one hour to be pyrogenic.

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