TOBI Podhaler Side Effects

Generic name: tobramycin

Medically reviewed by Drugs.com. Last updated on Nov 3, 2023.

Note: This document provides detailed information about TOBI Podhaler Side Effects associated with tobramycin. Some dosage forms listed on this page may not apply specifically to the brand name TOBI Podhaler.

Applies to tobramycin: injection solution.

Other dosage forms:

• inhalation capsule, inhalation solution

Important warnings This medicine can cause some serious health issues

Injection route (solution; powder for 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 periodically to assure adequate levels and to avoid potentially toxic levels.

Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided.

Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.

Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Serious side effects of TOBI Podhaler

Along with its needed effects, tobramycin (the active ingredient contained in TOBI Podhaler) 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 tobramycin:

Incidence not known

• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• cloudy urine
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• cracks in the skin
• decrease in the amount of urine
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• feeling of fullness in the ears
• fever
• loss of balance
• loss of heat from the body
• loss or change in hearing
• nausea
• pale skin
• pinpoint red spots on the skin
• red, swollen skin
• scaly skin
• sensation of spinning
• shortness of breath
• sore throat
• trouble in hearing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

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

Symptoms of overdose

• inability to breath without assistance

Other side effects of TOBI Podhaler

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:

Incidence not known

• confusion about identity, place, and time
• diarrhea
• headache
• hives or welts
• itching
• pain at the injection site
• redness of the skin
• skin rash
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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

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]

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]

Nervous system

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]

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

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]

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]

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

Inhalation/nebulizer solution:

• Very rare (less than 0.01%): Hypersensitivity

Parenteral formulations:

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

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

Further information

TOBI Podhaler 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.

Medical Disclaimer