Plazomicin Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 2, 2024.
Applies to plazomicin: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Warning: Nephrotoxicity, Ototoxicity, Neuromuscular Blockade and Fetal Harm. Nephrotoxicity 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 Cr. Cl 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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine and hearing tests may be needed to check for unwanted effects.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Check with your doctor right away if you have dizziness, feeling of fullness in the ears, loss of balance, loss of hearing, ringing or buzzing in the ears, or trouble in hearing. These may be symptoms of a serious hearing or balance problem.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
Plazomicin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.
Serious side effects of plazomicin
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 side effects
- 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 side effects
- 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
- burning feeling in the chest or stomach
- chest tightness
- dry mouth
- indigestion
- irregular heartbeat
- mood changes
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- seizures
- stomach upset
- tenderness in the stomach area
Other side effects of plazomicin
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 adverse events
The most commonly reported side effects included serum creatinine increases of 0.5 mg/dL or greater, decreased renal function, and diarrhea.[Ref]
Renal
- 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]
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]
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
Metabolic
- Frequency not reported: Hypokalemia[Ref]
Hepatic
- Frequency not reported: ALT increased[Ref]
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References
1. (2018) "Product Information. Zemdri (plazomicin)." Achaogen
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Further information
Plazomicin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.