Tobi
- Generic Name: tobramycin
- Brand Name: Tobi
Tobi (Tobramycin) side effects drug center
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- hoarseness,
- changes in voice, or
- an unpleasant taste or odor of the medication.
- signs of hearing damage (such as ringing or roaring sounds in the ears, hearing loss, dizziness), or
- an unusual decrease in the amount of urine.
- new or worsening breathing problems, such as wheezing, cough, chest tightness, or trouble breathing;
- hearing problems, ringing in your ears;
- hoarse voice;
- severe dizziness, spinning sensation, balance problems;
- weak or shallow breathing;
- muscle weakness; or
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
- cough, sore throat, hoarse voice;
- feeling short of breath;
- noisy breathing;
- worsening of lung problems or cystic fibrosis;
- coughing up mucus or blood;
- altered sense of taste;
- fever;
- headache; or
- rash.
Tobi (tobramycin) is an antibiotic used to treat lung infections in patients with cystic fibrosis. Common side effects of Tobi include:
Tell your doctor if you have unlikely but serious side effects of Tobi include:
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.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
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.
Read the entire detailed patient monograph for Tobi (Tobramycin)
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
| Adverse Event | TOBI (n=258) % |
Placebo (n=262) % |
| Cough Increased | 46.1 | 47.3 |
| Pharyngitis | 38.0 | 39.3 |
| Sputum Increased | 37.6 | 39.7 |
| Asthenia | 35.7 | 39.3 |
| Rhinitis | 34.5 | 33.6 |
| Dyspnea | 33.7 | 38.5 |
| Fever1 | 32.9 | 43.5 |
| Lung Disorder | 31.4 | 31.3 |
| Headache | 26.7 | 32.1 |
| Chest Pain | 26.0 | 29.8 |
| Sputum Discoloration | 21.3 | 19.8 |
| Hemoptysis | 19.4 | 23.7 |
| Anorexia | 18.6 | 27.9 |
| Lung Function Decreased2 | 16.3 | 15.3 |
| Asthma | 15.9 | 20.2 |
| Vomiting | 14.0 | 22.1 |
| Abdominal Pain | 12.8 | 23.7 |
| Voice Alteration | 12.8 | 6.5 |
| Nausea | 11.2 | 16.0 |
| Weight Loss | 10.1 | 15.3 |
| Pain | 8.1 | 12.6 |
| Sinusitis | 8.1 | 9.2 |
| Ear Pain | 7.4 | 8.8 |
| Back Pain | 7.0 | 8.0 |
| Epistaxis | 7.0 | 6.5 |
| Taste Perversion | 6.6 | 6.9 |
| Diarrhea | 6.2 | 10.3 |
| Malaise | 6.2 | 5.3 |
| Lower Respiratory Tract Infection | 5.8 | 8.0 |
| Dizziness | 5.8 | 7.6 |
| Hyperventilation | 5.4 | 9.9 |
| Rash | 5.4 | 6.1 |
| 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. |
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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 TissueDiisorders
Hypersensitivity, pruritus, urticaria, rash
Nervous System Disorders
Aphonia, dysgeusia
Respiratory, Thoracic, and Mediastinal Disorders
Bronchospasm (see WARNINGS–Bronchospasm), oropharyngeal pain
Metabolism and Nutrition Disorders
Decreased appetite
Read the entire FDA prescribing information for Tobi (Tobramycin)
© Tobi Patient Information is supplied by Cerner Multum, Inc. and Tobi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.