"The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease "...
Tobi Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tobi (tobramycin) is used to treat lung infections in patients with cystic fibrosis. It is an antibiotic. Common side effects include hoarseness and changes in voice.
The recommended dosage of Tobi for adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered twice daily for 28 days. Doses should be taken 12 hours apart; they should not be taken less than 6 hours apart. Tobi may interact with urosemide, ethacryinc acid, or mannitol. Do not mix Tobi with dornase alfa in the nebulizer. Tell your doctor all prescription or over-the-counter medicines and supplements you use. Tobi is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, the risk for harm may not be the same with this drug. Consult your doctor. It is unknown if inhaled tobramycin passes into breast milk. However, other forms of this drug pass into breast milk in very small amounts, and many doctors consider breastfeeding safe while using this drug. Consult your doctor before breastfeeding.
Our Tobi (tobramycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tobi in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- ringing in the ears or changes in hearing;
- new or worsening respiratory problems or difficulty breathing;
- muscle weakness; or
- a rash.
If you experience any of the following less serious side effects, continue using tobramycin and talk to your doctor:
- changes in voice; or
- unpleasant taste or odor of the medication.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Tobi (Tobramycin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tobi Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of hearing damage (such as ringing/roaring sounds in the ears, hearing loss, dizziness), unusual decrease in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/unusual trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tobi (Tobramycin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tobi FDA Prescribing Information: Side Effects
TOBI® was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI® in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI®treated patients. Thirty-three patients (13%) treated with TOBI® complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI® group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI® treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss.
The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI® and placebo groups.
Nine (3%) patients in the TOBI® group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI® group, creatinine decreased at the next visit.
Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in > 5% of TOBI® patients during the two Phase III studies.
Table 1: Percent of Patients With Treatment Emergent
Adverse Experiences Occurring in > 5% of TOBI® Patients
|Lung Function Decreased2||16.3||15.3|
|Lower Respiratory Tract Infection||5.8||8.0|
|1Includes subjective complaints of fever.
2Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.
Adverse drug reactions ( < 5%) occurring more frequently with TOBI in the placebo-controlled studies and assessed as drug-related in ≥ 1% of patients:
Ear And Labyrinth Disorders
Tinnitus (3.1%, vs 0% for placebo)
Musculoskeletal And Connective Tissue Disorders
Myalgia (4.7%, vs 2.7% for placebo)
Infections And Infestations
Laryngitis (4.3%, vs 3.1% for placebo)
Adverse Drug Reactions Derived From Spontaneous Reports
The following adverse reactions have been identified during postapproval use of TOBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ear And Labyrinth Disorders
Hearing loss (see WARNINGS - Ototoxicity)
Skin And Subcutaneous Tissue Disorders
Nervous System Disorders
Respiratory, Thoracic, And Mediastinal Disorders
Bronchospasm (see WARNINGS - Bronchospasm), oropharyngeal pain
Read the entire FDA prescribing information for Tobi (Tobramycin)
Additional Tobi Information
Tobi - User Reviews
Tobi User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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