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Kitabis Pak Side Effects

Generic Name: tobramycin

Note: This document contains side effect information about tobramycin. Some of the dosage forms listed on this page may not apply to the brand name Kitabis Pak.

For the Consumer

Applies to tobramycin: inhalation capsule, inhalation solution

Other dosage forms:

Along with its needed effects, tobramycin (the active ingredient contained in Kitabis Pak) 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 immediately if any of the following side effects occur while taking tobramycin:

More Common

  • Bloody nose
  • difficulty with breathing
  • discoloration of sputum
  • fever
  • runny nose
  • sneezing
  • stuffy nose
  • voice changes

Less Common

  • Black, tarry stools
  • chest pain
  • chills
  • continuing ringing or buzzing or other unexplained noise in the ears
  • hearing loss
  • painful or difficult urination
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking tobramycin:

Symptoms of Overdose

  • Blue lips, fingernails, or skin
  • dizziness or lightheadedness
  • drowsiness
  • feeling of constant movement of self or surroundings
  • irregular, fast or slow, or shallow breathing
  • sensation of spinning

Some side effects of tobramycin 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:

More Common

  • Back pain
  • general feeling of discomfort or illness
  • hoarseness

Less Common

  • Bloody nose
  • change or loss of taste
  • diarrhea
  • rash

For Healthcare Professionals

Applies to tobramycin: compounding powder, inhalation capsule, inhalation solution, injectable powder for injection, injectable solution, intravenous solution

General

Inhalation Capsules: The most commonly reported side effects included cough, lung disorder, productive cough, and dyspnea.

Inhalation/nebulizer solution: The most commonly reported side effects included increased cough, pharyngitis, fever, and increased sputum.

Parenteral formulations: The most commonly reported serious side effects included hypersensitivity reactions, ototoxicity, and nephrotoxicity.[Ref]

Respiratory

Inhalation Capsules:

Very common (10% or more): Cough (up to 48.4%), lung disorder (up to 33.8%), productive cough (up to 18.2%), dyspnea (up to 15.6%), oropharyngeal pain (up to 14%), dysphonia (up to 13.6%), hemoptysis (up to 13%), pharyngolaryngeal pain (up to 10.9%)

Common (1% to 10%): Bronchospasm, epistaxis, forced expiratory volume (FEV1) decreased, nasal congestion, pulmonary function test decreased, rales, throat irritation, upper respiratory tract infection, wheezing

Frequency not reported: Cystic fibrosis exacerbation, pulmonary exacerbation, sputum discolored

Inhalation/nebulizer solution:

Very common (10% or more): Cough increased (up to 50%), pharyngitis (up to 48%), sputum increased (up to 44%), dyspnea (up to 42%), rhinitis (up to 38%), lung disorder (up to 34%), cough (up to 31.1%), hemoptysis (up to 28%), lung function decreased (up to 29%), asthma (up to 28%), sputum discoloration (up to 25%), productive cough (up to 19.6%), sinusitis (up to 14%), upper respiratory tract infection (up to 14%), voice alteration (up to 13%), oropharyngeal pain (up to 10.5%)

Common (1% to 10%): Dysphonia, epistaxis, FEV1 decreased, hyperventilation, hypoxia, laryngitis, lower respiratory tract infection, nasal congestion, nasal polyp, pulmonary function test decreased, rales, respiratory disorder, throat irritation, wheezing

Rare (0.01% to 0.1%): Bronchospasm

Frequency not reported: Pulmonary exacerbation

Parenteral formulations:

Uncommon (0.1% to 1%): Apnea, respiratory depression[Ref]

Other

Ototoxicity, usually irreversible, was typically initially manifested by diminution of high-tone acuity, dizziness, hearing loss, roaring in the ears, tinnitus, and vertigo. Patients receiving inhalation formulations with a history of prolonged treatment and/or receiving concomitant IV treatment with an aminoglycoside have developed hearing loss. Ototoxicity may progress despite discontinuation in some patients.

Tinnitus was typically transient, usually resolved without discontinuation of treatment, and was associated with permanent hearing loss in some patients.[Ref]

Inhalation Capsules:

Very common (10% or more): Pyrexia (up to 15.6%)

Common (1% to 10%): Deafness, deafness unilateral, hypoacusis, increased hearing loss, mild to moderate hearing loss, tinnitus

Frequency not reported: Malaise

Inhalation/nebulizer solution:

Very common (10% or more): Fever (up to 46%), asthenia (up to 44%), pain (up to 24%), pyrexia (up to 12.4%)

Common (1% to 10%): Accidental injury, chills, malaise, otitis media, tinnitus

Uncommon (0.1% to 1%): Deafness neurosensory, hypoacusis, mucosal dryness

Rare (0.01% to 0.1%): Hearing loss

Very rare (less than 0.01%): Ear disorder, ear pain

Frequency not reported: Ototoxicity

Parenteral formulations:

Common (1% to 10%): Hearing loss/irreversible hearing loss, high frequency hearing loss, ototoxicity, roaring in the ears, tinnitus

Rare (0.01% to 0.1%): Fever

Frequency not reported: Transient cochlear toxicity[Ref]

Nervous system

Acute brain syndrome occurred in an elderly patient approximately 4 days after starting treatment.[Ref]

Inhalation Capsules:

Very common (10% or more): Headache (up to 11.4%)

Common (1% to 10%): Aphonia, dysgeusia

Inhalation/nebulizer solution:

Very common (10% or more): Headache (up to 34%), dysphonia (up to 13%)

Common (1% to 10%): Dizziness, somnolence, taste perversion

Uncommon (0.1% to 1%): Dysgeusia, vertigo

Rare (0.01% to 0.1%): Aphonia

Parenteral formulations:

Common (1% to 10%): Acute dizziness/dizziness, vertigo, vestibular dysfunction

Uncommon (0.1% to 1%): Exacerbation of impairment of neuromuscular transmission, neuromuscular blocking effects

Rare (0.01% to 0.1%): Acute brain syndrome, lethargy, neurotoxicity

Frequency not reported: Headache[Ref]

Cardiovascular

Inhalation Capsules:

Common (1% to 10%): Chest discomfort

Inhalation/nebulizer solution:

Very common (10% or more): Chest pain (up to 37%)

Common (1% to 10%): Chest discomfort[Ref]

Gastrointestinal

Inhalation Capsules:

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

Inhalation/nebulizer solution:

Very common (10% or more): Abdominal pain (up to 27%)

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

Uncommon (0.1% to 1%): Abdominal pain upper, glossitis, salivary hypersecretion

Rare (0.01% to 0.1%): Mouth ulceration

Parenteral formulations:

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

Rare (0.01% to 0.1%): Stomatitis[Ref]

Renal

Nephrotoxicity, demonstrated by rising BUN, NPN, serum creatinine, cylindruria, oliguria, and proteinuria, primarily occurred in patients with preexisting renal damage and in patients with normal renal function treated for longer periods and/or at higher doses than recommended. Predisposing factors also included advanced age, dehydration, and concomitant use of other potentially nephrotoxic drugs.

Signs of renal failure included elevated serum creatinine and urea, and may be a rare complication in patients with cystic fibrosis.[Ref]

Inhalation/nebulizer solution:

Frequency not reported: Nephrotoxicity

Parenteral formulations:

Common (1% to 10%): Decreased glomerular filtration, elevated urea concentrations, increased blood urea nitrogen (BUN), increased nonprotein nitrogen (NPN), oliguria, reduced creatinine clearance, reduced renal function, renal function changes, reversible nephrotoxicity

Uncommon (0.1% to 1%): Increased serum creatinine

Rare (0.01% to 0.1%): Acute renal failure, interstitial nephritis[Ref]

Musculoskeletal

Inhalation Capsules:

Common (1% to 10%): Musculoskeletal chest pain

Inhalation/nebulizer solution:

Common (1% to 10%): Back pain, musculoskeletal chest pain, myalgia

Parenteral formulations:

Uncommon (0.1% to 1%): Skeletal muscle weakness[Ref]

Dermatologic

Inhalation Capsules:

Common (1% to 10%): Rash

Inhalation/nebulizer solution:

Common (1% to 10%): Rash

Very rare (less than 0.01%): Pruritus, urticaria

Parenteral formulations:

Uncommon (0.1% to 1%): Itching, maculopapular rash, urticaria

Rare (0.01% to 0.1%): Exfoliative dermatitis, rash[Ref]

Genitourinary

Parenteral formulations:

Common (1% to 10%): Cylindruria, increased proteinuria[Ref]

Immunologic

Inhalation/nebulizer solution:

Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Fungal infection, oral candidiasis[Ref]

Metabolic

Inhalation Capsules:

Common (1% to 10%): Blood glucose increased

Inhalation/nebulizer solution:

Uncommon (0.1% to 1%): Blood glucose increased

Rare (0.01% to 0.1%): Anorexia

Postmarketing reports: Decreased appetite

Parenteral formulations:

Rare (0.01% to 0.1%): Hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypouricemia, metabolic syndrome

Frequency not reported: Increased serum lactate dehydrogenase[Ref]

Patients have developed a complex metabolic syndrome lasting approximately 2 to 8 weeks after administration of this drug; this syndrome was marked by hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypouricemia, and increased AST, ALT, serum bilirubin, and alkaline phosphatase.[Ref]

Hematologic

Inhalation/nebulizer solution:

Common (1% to 10%): Lymphadenopathy

Parenteral formulations:

Rare (0.01% to 0.1%): Anemia, chemotaxis inhibition, decreased platelet counts, decreased white cell counts, eosinophilia, granulocytopenia, inhibition of microbicidal activity of phagocytes, thrombocytopenia

Frequency not reported: Leukocytosis, leukopenia[Ref]

Hepatic

Inhalation/nebulizer solution:

Uncommon (0.1% to 1%): Transaminases increased

Parenteral formulations:

Rare (0.01% to 0.1%): Increased alkaline phosphatase, increased ALT, increased AST, increased serum bilirubin[Ref]

Hypersensitivity

Hypersensitivity reactions included anaphylaxis, angioedema, exfoliative dermatitis, and stomatitis.[Ref]

Inhalation/nebulizer solution:

Very rare (less than 0.01%): Hypersensitivity

Parenteral formulations:

Rare (0.01% to 0.1%): Anaphylaxis, angioedema, hypersensitivity reactions[Ref]

Local

Parenteral formulations:

Rare (0.01% to 0.1%): Pain (IM administration), thrombophlebitis (IV administration)[Ref]

Psychiatric

Parenteral formulations:

Frequency not reported: Delirium, disorientation, mental confusion[Ref]

Delirium was reversible after treatment was discontinued.[Ref]

References

1. "Product Information. Nebcin (tobramycin)." Lilly, Eli and Company, Indianapolis, IN.

2. "Product Information. Tobi tobramycin solution for inhalation (tobramycin)" PathoGenesis, Skokie, IL.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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