Amikin Pediatric Side Effects
Generic name: amikacin
Medically reviewed by Drugs.com. Last updated on Apr 14, 2024.
Note: This document provides detailed information about Amikin Pediatric Side Effects associated with amikacin. Some dosage forms listed on this page may not apply specifically to the brand name Amikin Pediatric.
Applies to amikacin: injection solution.
Important Warnings
This medicine can cause some serious health issues
Injection route (Solution)
Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity.
Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity.
Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity.
Aminoglycoside-induced ototoxicity is usually irreversible.
Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels.
Neuromuscular blockade and respiratory paralysis have also been reported following administration.
Concurrent use of other potentially neurotoxic agents, nephrotoxic agents, or potent diuretics should be avoided.
Serious side effects of Amikin Pediatric
Along with its needed effects, amikacin (the active ingredient contained in Amikin Pediatric) 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 amikacin:
Incidence not known
- agitation
- black, tarry stools
- bloody or cloudy urine
- bluish lips or skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- coma
- confusion
- cough
- decrease in the amount of urine
- decreased urine output
- depression
- difficulty with breathing
- difficulty with moving
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- feeling of fullness in the ears
- fever
- headache
- hearing loss
- irritability
- lethargy
- loss of balance
- loss or change in hearing
- muscle pain or stiffness
- muscle twitching
- nausea
- not breathing
- pain in the joints
- pain in the lower back or side
- painful or difficult urination
- pale skin
- rapid weight gain
- ringing or buzzing in the ears
- seizures
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stupor
- sweating
- swelling of the face, ankles, or hands
- swollen glands
- thirst
- trembling or shaking of the hands or feet
- trouble with hearing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects of Amikin Pediatric
Some side effects of amikacin 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
- skin rash
- vomiting
For Healthcare Professionals
Applies to amikacin: compounding powder, injectable solution, intravenous solution.
General
The most commonly reported side effects included injection site paint and hearing loss (permanent in some cases).[Ref]
Renal
- Common (1% to 10%): Azotemia, decreased creatinine clearance, decreased renal function, increased serum creatinine, increased serum urea
- Uncommon (0.1% to 1%): Renal failure
- Frequency not reported: Acute renal failure, cells in urine, renal toxicity, toxic nephropathy[Ref]
Renal function changes were usually reversible when the drug was discontinued.[Ref]
Other
- Common (1% to 10%): Hearing loss, permanent hearing loss
- Uncommon (0.1% to 1%): Changes in caloric testing/electronystagmus, drug fever
- Rare (0.01% to 0.1%): Pyrexia
- Frequency not reported: Auditory toxicity, cochlear damage, deafness, generalized burning, high frequency deafness, lethargy, neurosensory deafness, ototoxicity, vestibular toxicity[Ref]
Initial hearing loss usually manifests as diminution of high-tone acuity.[Ref]
Genitourinary
- Common (1% to 10%): Oliguria, protein in the urine
- Rare (0.01% to 0.1%): Albuminuria, red blood cells in urine, white blood cells in urine[Ref]
Local
- Common (1% to 10%): Injection site pain[Ref]
Injection site pain occurred with IM administration.[Ref]
Nervous system
- Uncommon (0.1% to 1%): Dizziness, paresthesia, tremor, vertigo
- Rare (0.01% to 0.1%): Balance disorder, headache
- Frequency not reported: Acute organic brain syndrome, confusion, convulsions, eighth cranial nerve toxicity, loss of balance, neuromuscular blockade, paralysis, pseudotumor cerebri[Ref]
Gastrointestinal
- Uncommon (0.1% to 1%): Nausea, vomiting
- Frequency not reported: Increased salivation, stomatitis[Ref]
Immunologic
- Uncommon (0.1% to 1%): Superinfections or colonization with resistant bacteria or yeast[Ref]
Dermatologic
- Uncommon (0.1% to 1%): Rash/skin rash
- Rare (0.01% to 0.1%): Pruritus, urticaria
- Frequency not reported: Alopecia[Ref]
Musculoskeletal
- Uncommon (0.1% to 1%): Arthralgia
- Rare (0.01% to 0.1%): Muscle twitching
- Frequency not reported: Acute muscular paralysis, joint pain, myasthenia gravis-like syndrome[Ref]
Hematologic
- Uncommon (0.1% to 1%): Anemia
- Rare (0.01% to 0.1%): Eosinophilia
- Frequency not reported: Purpura, splenomegaly[Ref]
Hepatic
- Uncommon (0.1% to 1%): AST increased
- Frequency not reported: Transient hepatomegaly[Ref]
Ocular
- Rare (0.01% to 0.1%): Blindness, macular infarction, permanent vision loss, retinal infarction
- Frequency not reported: Visual disturbances[Ref]
Blindness, macular infarction, and retinal infarction occurred after intravitreous administration.[Ref]
Metabolic
- Rare (0.01% to 0.1%): Hypomagnesemia
- Frequency not reported: Anorexia, decreased appetite, weight loss[Ref]
Cardiovascular
- Rare (0.01% to 0.1%): Hypotension
- Frequency not reported: Hypertension[Ref]
Hypersensitivity
- Frequency not reported: Anaphylactic reaction, anaphylactic response, anaphylactic shock, anaphylactoid reaction, hypersensitivity[Ref]
Respiratory
- Frequency not reported: Apnea, bronchospasm, laryngeal edema, pulmonary fibrosis, respiratory depression[Ref]
Psychiatric
- Frequency not reported: Depression[Ref]
References
1. (2002) "Product Information. Amikin (amikacin)." Bristol-Myers Squibb
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
More about Amikin Pediatric (amikacin)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: aminoglycosides
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Further information
Amikin Pediatric 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.
Some side effects may not be reported. You may report them to the FDA.