Evigrade

Gentamicin

AEMPS

Aminoglycoside antibiotic

ATC code: J01GB03

Brand names: Garamycin, Gentak

Updated · Methodology

Indications

A

Acute brucellosis

First line

In acute uncomplicated brucellosis, gentamicin belongs to the first-line doxycycline + gentamicin combination rather than acting as an optional add-on. In a 2024 network meta-analysis of randomized controlled trials (PLoS Neglected Tropical Diseases), doxycycline + gentamicin ranked first for efficacy and safety (SUCRA 0.94), ahead of the standard doxycycline + rifampicin. Earlier meta-analyses of randomized controlled trials (BMJ 2008, PLoS One 2012) showed that aminoglycoside-containing regimens produce fewer relapses and treatment failures. Gentamicin strengthens the bactericidal activity of doxycycline against intracellular Brucella.

ICD-10: A23 · ICD-11: 1B95

A

Early-onset neonatal sepsis

First line

Gentamicin is a first-line agent for empirical treatment of early-onset neonatal sepsis, but only as the mandatory second drug alongside a beta-lactam: NG195 (2021) names benzylpenicillin with gentamicin as the first-choice regimen, and the (2018) recommends ampicillin with an aminoglycoside. The combination covers the main pathogens (group B streptococcus, Escherichia coli, and Listeria), with gentamicin adding synergy against the beta-lactam's targets. Gentamicin here is co-first-line rather than reserve, and is given once daily (Cochrane, Rao 2016). Cochrane systematic reviews (2021, 2016) support this regimen and the choice of combination.

ICD-10: P36 · ICD-11: KA60

A

Enterococcus faecalis infective endocarditis

First line

In endocarditis caused by Enterococcus faecalis without high-level aminoglycoside resistance (non-HLAR), gentamicin is first-line: ampicillin plus gentamicin carries a Class I recommendation in the 2023 and / 2015 guidelines, on par with ampicillin plus ceftriaxone. Gentamicin is given at 3 mg/kg/day in 2–3 divided doses for a synergistic bactericidal effect with the beta-lactam, since beta-lactam therapy alone is only bacteriostatic against enterococci. Ampicillin plus ceftriaxone is an equivalent alternative when there is a risk of nephrotoxicity (Fernandez-Hidalgo, 2013), and this does not lower gentamicin's first-line status for non-HLAR strains. In staphylococcal endocarditis gentamicin plays a different role and is not first-line, so this entry should not be merged with broad gram-positive endocarditis.

ICD-10: I33 · ICD-11: BB40

A

Pelvic inflammatory disease

First line

In severe PID treated in hospital, intravenous gentamicin is part of one of the recommended parenteral regimens, combined with clindamycin, where the aminoglycoside adds Gram-negative coverage and complements anaerobic activity. In the CDC STI Treatment Guidelines, 2021, this regimen stands alongside the cephalosporin-based regimens with no reserve designation. The 2017 Cochrane systematic review found clindamycin plus an aminoglycoside non-inferior to cephalosporins and quinolones for cure rates. Once the patient improves clinically, parenteral therapy is switched to oral treatment.

ICD-10: N73 · ICD-11: GA05.Z

A

Plague

First line

Gentamicin is a first-line agent for plague alongside streptomycin: aminoglycosides are recommended as primary parenteral therapy by the CDC (MMWR, 2021) and (2021) guidelines. Treatment starts immediately when plague is suspected, without waiting for confirmation. In U.S. case series, aminoglycoside monotherapy showed survival of about 84% (systematic review, Clinical Infectious Diseases, 2020). In pregnancy, gentamicin is the preferred aminoglycoside.

ICD-10: A20 · ICD-11: 1B93

A

Tularemia

First line

In severe tularemia, gentamicin is the preferred first-line aminoglycoside. The most recent CDC guidance (MMWR 2025) names it the drug of choice and advises starting with an aminoglycoside in severe disease, moving streptomycin to third line. A 2024 systematic review reports mortality on aminoglycoside therapy of about 0.7%. In pregnancy, gentamicin is preferred over streptomycin. Treatment is parenteral with monitoring of kidney function.

ICD-10: A21 · ICD-11: 1B94

B

Complicated urinary tract infection

Second line

Gentamicin is used for complicated UTI and acute pyelonephritis requiring parenteral therapy as an alternative to third-generation cephalosporins and fluoroquinolones. Advantages include activity against Pseudomonas and ESBL producers in some regions. 2010 includes aminoglycosides in complicated UTI regimens in groups at risk of resistance. After clinical response within 48–72 hours, switch to an oral agent guided by susceptibility.

ICD-10: N10 · ICD-11: GB51

B

Gram-negative sepsis

Adjunct

Gentamicin is included in empirical regimens for suspected gram-negative bacteremia or sepsis in combination with a broad-spectrum beta-lactam. Surviving Sepsis Campaign 2021 recommends dual gram-negative coverage on day 1 in unstable patients and where multidrug-resistant pathogens are likely. After susceptibility data and patient stabilization, therapy is de-escalated. Once-daily dosing (5–7 mg/kg) is preferred for efficacy and safety, supported by the 2014 Cochrane review.

ICD-10: A41.5 · ICD-11: 1G40

B

Gram-positive infective endocarditis

Adjunct

In gram-positive infective endocarditis (staphylococcal, streptococcal), gentamicin is not the backbone but a short synergistic add-on to a beta-lactam or vancomycin in selected situations, such as the early phase of prosthetic-valve disease. The 2023 guidelines cut back routine gentamicin because of nephrotoxicity: in most regimens it does not improve outcomes and is not recommended. The backbone is a beta-lactam or vancomycin, with gentamicin kept as a reserve component under renal-function monitoring. For Enterococcus faecalis endocarditis the role differs, where ampicillin plus gentamicin is part of first-line therapy.

Peak and trough levels are monitored: trough below 1 mcg/mL. In patients with renal impairment or ventilator-associated infection, dose and interval are adjusted to eGFR.

ICD-10: I33.0 · ICD-11: BB40

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Uncomplicated acute cystitis in women

Not recommended

For uncomplicated acute cystitis in non-pregnant outpatient women, gentamicin is not prescribed. Parenteral administration carrying nephrotoxicity and ototoxicity risks is not justified when effective oral options exist (nitrofurantoin, fosfomycin, trimethoprim-sulfamethoxazole). NG109 2018 and classify aminoglycosides as inpatient reserve agents, not as outpatient cystitis therapy.

ICD-10: N30.0 · ICD-11: GC00.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Binds the 30S bacterial ribosomal subunit and disrupts mRNA decoding, producing nonfunctional proteins and bacterial death. Active against most aerobic gram-negative organisms and staphylococci. Not absorbed from GI tract – only parenteral. Not metabolised, renally excreted. Main adverse effects are nephrotoxicity (10–20%) and ototoxicity (5%), cumulative with prolonged therapy.

Safety

Boxed warning

FDA boxed warning: gentamicin causes nephrotoxicity and oto- and vestibulotoxicity, including irreversible. Risk increases with renal impairment, therapy longer than 10 days, high cumulative doses, concomitant nephrotoxic or ototoxic agents. Neuromuscular blockade up to respiratory failure has been reported with concomitant muscle relaxants and in myasthenic patients. Therapy is conducted with mandatory monitoring of drug levels, renal function, and hearing.

Contraindications

  • Aminoglycoside hypersensitivity
  • Myasthenia gravis (enhanced neuromuscular blockade)
  • Combination with other nephrotoxic or ototoxic drugs (vancomycin, furosemide, cisplatin)

Serious adverse effects

  • Acute kidney injury
  • Irreversible deafness (vestibular and cochlear)
  • Neuromuscular blockade with respiratory depression

Common adverse effects

  • Nephrotoxicity (rising creatinine)
  • Ototoxicity (tinnitus, hearing loss)
  • Nausea
  • Rash

Uncommon adverse effects

  • Neuromuscular blockade, especially in patients with myasthenia
  • Rash, drug fever
  • Hypomagnesemia, hypocalcemia

Pregnancy: can you take Gentamicin?

Congenital deafness in fetus reported. Use only when benefit clearly outweighs risk.

Breastfeeding: can you take Gentamicin?

Passes into milk in small amounts. Oral bioavailability in infant minimal. Breastfeeding possible.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Standard regimen is once-daily dosing 5–7 mg/kg intravenously over 30–60 minutes or intramuscularly when hemodynamically stable. Once-daily dosing provides better pharmacodynamics (concentration-dependent killing) and reduces nephrotoxicity risk compared with three-times-daily dosing. In endocarditis, the dose is divided into 3 administrations for beta-lactam synergy.

Dose titration

The dose is calculated using "adjusted body weight" in obese patients: ideal body weight + 0.4 × (actual - ideal). At eGFR 60–90 mL/min/1.73 m² the interval is 24 hours; at eGFR 40–60, 36 hours; at eGFR 20–40, 48 hours. In hemodialysis patients, 1–2 mg/kg is given after the session. Course duration is kept to 7–10 days when possible.

Monitoring

Trough levels are checked before the next dose: below 1 mcg/mL for once-daily regimens, below 2 mcg/mL for three-times-daily. Creatinine and eGFR are checked at 24–48 hours after the first dose and every 2–3 days. Audiogram and vestibular assessment are performed at baseline and on day 5–7, then weekly if therapy continues beyond 7–10 days. Tinnitus, vertigo, or hearing impairment is an immediate indication for discontinuation.

Special situations

In elderly patients and with concomitant loop diuretics, vancomycin, or high-dose ampicillin, the risks of nephro- and ototoxicity rise. Alternatives are discussed before prescribing. In patients with myasthenia the drug is avoided: even a single dose causes neuromuscular blockade. With planned concomitant muscle relaxants, the anesthesiologist adjusts the relaxant dose.

Common myths

Myth: "gentamicin is broad-spectrum, fits any infection". Fact: the spectrum is narrow – gentamicin acts on gram-negative rods and some gram-positive cocci in synergy with a beta-lactam. It is ineffective against anaerobes and atypical pathogens.

Myth: "toxic only with long therapy". Fact: ototoxicity has been reported with short 5-7-day courses in susceptible patients (m.1555A>G genetic variant, older age, renal impairment).


Myth: "dose can be selected without monitoring". Fact: the therapeutic index is narrow; without level monitoring (or at minimum eGFR and audiogram), the risk of irreversible hearing loss and renal failure rises several-fold.

Drug–nutrient interactions

Potassium

Tubular damage from gentamicin is accompanied by potassium loss. Hypokalemia occurs in 20-30% of patients on prolonged therapy, especially with loop diuretics or amphotericin B. Potassium is monitored daily in critically ill patients and corrected to 4.0-4.5 mmol/L to reduce arrhythmia risk.

Magnesium

Gentamicin damages the proximal tubules and impairs magnesium reabsorption, leading to hypomagnesemia in 30-50% of cases during courses longer than 7 days. Hypomagnesemia worsens QT prolongation and arrhythmia risk. Serum magnesium is checked before starting and every 2-3 days of therapy. When it falls below 0.7 mmol/L, replacement is given.

Drug–drug interactions

5 pairs found. Sorted from critical to minor.

MajorAmphotericin BPolyene systemic antifungal

Mechanism

Both nephrotoxic. Combined use gives additive AKI risk.

Symptoms

Creatinine rise within 5-7 days.

Management

Daily creatinine monitoring, minimise course duration.

Pair details →Amphotericin B →

MajorFurosemideLoop diuretics

Mechanism

Gentamicin (an aminoglycoside) is directly oto- and nephrotoxic. Furosemide can also damage the cochlea and reduces renal perfusion via volume depletion. Effects are additive – irreversible sensorineural hearing loss and acute kidney injury have been reported.

Symptoms

Tinnitus, hearing loss, vertigo. Severe cases progress to deafness that does not recover after withdrawal. In parallel: reduced urine output, rising creatinine.

Management

Avoid the combination. If unavoidable, use the minimum effective furosemide dose with daily creatinine and hearing checks (audiometry where possible). Dose gentamicin once daily by weight and renal function, with protocol-driven level monitoring.

Pair details →Furosemide →

MajorIopromideX-ray contrast media. Watersoluble nephrotropic low-osmolar iodinated agents

Mechanism

Additive nephrotoxicity. Gentamicin (an aminoglycoside) directly injures proximal renal tubules; iodinated contrast (iopromide) adds osmotic load. Acute tubular necrosis risk multiplies.

Symptoms

Reduced urine output, rising creatinine and urea, proteinuria. Severe cases include oliguria and need for haemodialysis. Symptoms appear 1–3 days after contrast.

Management

Postpone the contrast study until the gentamicin course ends where possible. If contrast is urgent, ensure adequate hydration (saline 1 mL/kg/h for 12 hours before and after), stop other nephrotoxic drugs, and check creatinine daily.

Pair details →Iopromide →

MajorTacrolimusCalcineurin inhibitor (immunosuppressant)

Mechanism

Additive nephrotoxicity via two distinct mechanisms. Gentamicin (an aminoglycoside) directly injures proximal renal tubules. Tacrolimus (calcineurin inhibitor) causes afferent arteriolar vasoconstriction. Co-administration sharply raises acute kidney injury risk, especially in transplant patients.

Symptoms

Reduced urine output, rising creatinine and urea. In kidney transplant patients: accelerated graft decline. Gentamicin ototoxicity too: tinnitus, hearing loss.

Management

Avoid the combination. Alternative antibiotics: a cephalosporin, carbapenem, or vancomycin (with its own renal monitoring). If gentamicin is irreplaceable: minimum effective dose, daily creatinine checks, and gentamicin level monitoring per protocol.

Pair details →Tacrolimus →

ModerateAcetylsalicylic acidAntiplatelet agents (low dose) / NSAIDs (analgesic dose)

Mechanism

Additive nephrotoxicity. Aspirin suppresses prostaglandin-dependent renal blood flow (at high doses); gentamicin causes direct tubulotoxicity.

Symptoms

Reduced urine output, rising creatinine. Symptoms appear earlier in older patients and chronic kidney disease.

Management

Cardioprotective aspirin doses (75–100 mg) do not require withdrawal. At high doses, check creatinine before and 3–5 days into gentamicin therapy. Ensure adequate hydration; consider switching to a less nephrotoxic antibiotic (a cephalosporin, carbapenem).

Pair details →Acetylsalicylic acid →

Label mentions10 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «Fármacos potencialmente nefrotóxicos u ototóxicos: Debido al mayor riesgo de efectos no deseados, se requiere una cuidadosa supervisión de los pacientes que reciben tratamiento simultáneo o…»

    AEMPS, section 4.5 · Open on CIMA

  • «Fármacos potencialmente nefrotóxicos u ototóxicos: Debido al mayor riesgo de efectos no deseados, se requiere una cuidadosa supervisión de los pacientes que reciben tratamiento simultáneo o…»

    AEMPS, section 4.5 · Open on CIMA

  • Majordiuréticos del asaclass named in the label
    «Fármacos potencialmente nefrotóxicos u ototóxicos: Debido al mayor riesgo de efectos no deseados, se requiere una cuidadosa supervisión de los pacientes que reciben tratamiento simultáneo o…»

    AEMPS, section 4.5 · Open on CIMA

  • «Fármacos potencialmente nefrotóxicos u ototóxicos: Debido al mayor riesgo de efectos no deseados, se requiere una cuidadosa supervisión de los pacientes que reciben tratamiento simultáneo o…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebloqueantes neuromuscularesclass named in the label
    «Si la gentamicina se administra durante o inmediatamente después de una intervención quirúrgica, el bloqueo neuromuscular puede potenciarse y prolongarse si se utilizan relajantes musculares no…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatediuréticosclass named in the label
    «No debe administrarse simultáneamente con productos neuro o nefrotóxicos ni con diuréticos potentes.»

    AEMPS, section 4.3 · Open on CIMA

From other drugs’ labels

  • ModerateCiclosporin
    «Combinaciones con mayor riesgo de nefrotoxicidad: Deberá tenerse precaución cuando se utilice ciclosporina junto con otros fármacos que presentan sinergia nefrotóxica como son: aminoglucósidos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Se ha descrito hipopotasemia en pacientes que toman fármacos citotóxicos para la leucemia cuando se les administró gentamicina y cefalexina.»

    AEMPS, section 4.5 · Open on CIMA

  • «amiodarona, flecainida, prazosin, propafenona, quinidina, espironolactona, eritromicina, tetraciclina, gentamicina, itraconazol, quinina, trimetoprima, alprazolam, difenoxilato con atropina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Pharmacokinetic Drug Interactions: Gentamicin 129 to 212% NA»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Gentamicin used for?

Gentamicin is evaluated for the following indications with varying evidence strength: Tularemia (evidence tier A), Early-onset neonatal sepsis (evidence tier A), Plague (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Gentamicin?

Common side effects of Gentamicin (≥ 1 in 100): Nephrotoxicity (rising creatinine), Ototoxicity (tinnitus, hearing loss), Nausea, Rash. See the Safety section for uncommon and serious reactions.

Is Gentamicin safe during pregnancy?

Congenital deafness in fetus reported. Use only when benefit clearly outweighs risk.

Is Gentamicin compatible with breastfeeding?

Passes into milk in small amounts. Oral bioavailability in infant minimal. Breastfeeding possible.

Who should not take Gentamicin?

Gentamicin is contraindicated in: Aminoglycoside hypersensitivity; Myasthenia gravis (enhanced neuromuscular blockade); Combination with other nephrotoxic or ototoxic drugs (vancomycin, furosemide, cisplatin). Full list in the Safety section.

Does Gentamicin carry an FDA boxed warning?

FDA boxed warning: gentamicin causes nephrotoxicity and oto- and vestibulotoxicity, including irreversible. Risk increases with renal impairment, therapy longer than 10 days, high cumulative doses, concomitant nephrotoxic or ototoxic agents. Neuromuscular blockade up to respiratory failure has been reported with concomitant muscle relaxants and in myasthenic patients. Therapy is conducted with mandatory monitoring of drug levels, renal function, and hearing.

gentamicin is broad-spectrum, fits any infection

the spectrum is narrow – gentamicin acts on gram-negative rods and some gram-positive cocci in synergy with a beta-lactam. It is ineffective against anaerobes and atypical pathogens.

toxic only with long therapy

ototoxicity has been reported with short 5-7-day courses in susceptible patients (m.1555A>G genetic variant, older age, renal impairment).

dose can be selected without monitoring

the therapeutic index is narrow; without level monitoring (or at minimum eGFR and audiogram), the risk of irreversible hearing loss and renal failure rises several-fold.

Official sources

Direct links to regulator labels. Open in a new tab.

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