Amikin Pediatric Side Effects
Generic Name: amikacin
Note: This page contains information about the side effects of amikacin. Some of the dosage forms included on this document may not apply to the brand name Amikin Pediatric.
Not all side effects for Amikin Pediatric may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to amikacin: injection solution
In addition to its needed effects, some unwanted effects may be caused by amikacin (the active ingredient contained in Amikin Pediatric). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking amikacin, check with your doctor or nurse immediately:Incidence not known
- 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
- decrease in the amount of urine
- decreased urine output
- difficulty with breathing
- difficulty with moving
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- feeling of fullness in the ears
- hearing loss
- loss of balance
- loss or change in hearing
- muscle pain or stiffness
- muscle twitching
- 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
- 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
- swelling of the face, ankles, or hands
- swollen glands
- trembling or shaking of the hands or feet
- trouble with hearing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Some of the side effects that can occur with amikacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Incidence not known
- Skin rash
For Healthcare Professionals
Applies to amikacin: compounding powder, intravenous solution
All aminoglycosides have the potential to cause auditory, vestibular, and renal toxicity and neuromuscular blockade. Such side effects occurred more often in patients with current or past history of renal impairment, of treatment with other ototoxic or nephrotoxic agents, and in patients treated for longer periods and/or with higher doses than recommended.
Such renal function changes were usually reversible when the drug was discontinued.
Predisposing factors have included advanced age, preexisting renal insufficiency, dehydration, and concomitant use of other potentially nephrotoxic drugs. One study has shown that hyperbilirubinemia in patients with biliary obstruction may also be a predisposing factor to aminoglycoside nephrotoxicity.
In one prospective, nonrandomized study, patients developed nephrotoxicity in 25% of amikacin (the active ingredient contained in Amikin Pediatric) courses.
Frequency not reported: Nephrotoxicity, elevated serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, oliguria
Ototoxicity may be irreversible and usually includes loss of auditory function secondary to cochlear hair cell damage. Damage may also be vestibular.
High frequency deafness usually occurs before hearing loss can be detected. Hearing loss may be permanent.
Rare neurologic side effects have included neuromuscular blockade, particularly in patients who are predisposed, including patients with myasthenia gravis, hypocalcemia, and patients on concomitant neuromuscular blocking agents.
A case of irreversible sensorineural hearing loss has been reported in a patient with diabetic end stage renal disease, after using an amikacin-heparin lock for 16 weeks (25 mg amikacin (the active ingredient contained in Amikin Pediatric) three times a week).
Rare (less than 0.1%): Headache, paresthesia, tremor
Frequency not reported: Neurotoxicity, ototoxicity (including vestibular and permanent bilateral auditory ototoxicity), neuromuscular blockade, toxic effects on the eighth cranial nerve, hearing loss, loss of balance, cochlear damage, high frequency deafness, total or partial irreversible bilateral deafness, acute muscular paralysis due to neuromuscular blockade, numbness, skin tingling, muscle twitching, convulsions, dizziness, vertigo, tinnitus, roaring in the ears
Frequency not reported: Respiratory paralysis/apnea due to neuromuscular blockade
Rare (less than 0.1%): Arthralgia
Rare (less than 0.1%): Nausea, vomiting
Rare (less than 0.1%): Anemia, eosinophilia
Rare (less than 0.1%): Hypotension
Frequency not reported: Hypersensitivity myocarditis
Rare (less than 0.1%): Skin rash, pruritus, exfoliative dermatitis
Rare (less than 0.1%): Fever, drug fever
Rare (less than 0.1%): Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome (at least 1 case)
Frequency not reported: Elevations in liver function tests (clinical significance unknown)
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