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Plazomicin Side Effects

Medically reviewed by Drugs.com. Last updated on July 7, 2020.

For the Consumer

Applies to plazomicin: intravenous solution

Warning

Intravenous route (Solution)

Warning: Nephrotoxicity, Ototoxicity, Neuromuscular Blockade and Fetal HarmNephrotoxicity has been reported with plazomicin. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Therapeutic drug monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CrCl less than 90 mL/min to avoid potentially toxic levels.Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with plazomicin. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended.Aminoglycosides have been associated with neuromuscular blockade. During therapy with plazomicin, monitor for adverse reactions associated with neuromuscular blockade, particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or in patients concomitantly receiving neuromuscular blocking agents.Aminoglycosides, including plazomicin, can cause fetal harm when administered to a pregnant woman.

Side effects requiring immediate medical attention

Along with its needed effects, plazomicin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking plazomicin:

More common

  • Blood in the urine
  • change in the frequency of urination or amount of urine
  • difficulty in breathing
  • drowsiness
  • increased thirst
  • loss of appetite
  • nausea
  • swelling of the feet or lower legs
  • vomiting

Less common

  • Blurred vision
  • cloudy urine
  • confusion
  • decrease in urine-concentrating ability
  • diarrhea
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of fullness in the ears
  • headache
  • loss of balance
  • loss of hearing
  • nervousness
  • pounding in the ears
  • ringing or buzzing in the ears
  • slow or fast heartbeat
  • trouble in hearing
  • unusual tiredness or weakness

Incidence not known

Side effects not requiring immediate medical attention

Some side effects of plazomicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to plazomicin: intravenous solution

General

The most commonly reported side effects included serum creatinine increases of 0.5 mg/dL or greater, decreased renal function, and diarrhea.[Ref]

Renal

Serum creatinine increases of at least 0.5 mg/dL above baseline occurred in approximately 7% of patients given this drug, compared to 4% of patients given meropenem; this effect primarily occurred in patients with CrCl 90 mL/min or less, and resulted in trough levels of at least 3 mcg/mL.[Ref]

Common (1% to 10%): Acute kidney injury, chronic kidney disease, creatinine clearance decreased, decreased renal function/renal dysfunction, renal failure, serum creatinine increased

Frequency not reported: Nephrotoxicity[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting

Frequency not reported: Clostridium difficile-associated diarrhea, constipation, gastritis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension[Ref]

Other

Common (1% to 10%): Ototoxicity

Uncommon (0.1% to 1%): Reversible hypoacusis

Frequency not reported: Abnormal audiogram, fetal harm, hearing loss, irreversible tinnitus, tinnitus[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Dizziness, neuromuscular blockade, vertigo[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reactions, hypersensitivity reactions[Ref]

Respiratory

Frequency not reported: Dyspnea[Ref]

Genitourinary

Frequency not reported: Hematuria[Ref]

Metabolic

Frequency not reported: Hypokalemia[Ref]

Hepatic

Frequency not reported: ALT increased[Ref]

References

1. "Product Information. Zemdri (plazomicin)." Achaogen, South San Francisco, CA.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.