Applies to amikacin: injection solution.

Serious side effects of Amikacin

Along with its needed effects, amikacin 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 Amikacin

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]