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What are the possible side effects of Linezolid?
Get emergency medical help if you have any of these signs of an allergic reaction to Linezolid: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
diarrhea that is watery or bloody;
vision problems, changes in color vision;
agitation, hallucinations, fever, fast heart rate, overactive reflexes, diarrhea, loss of coordination, fainting;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
lactic acidosis--muscle pain or weakness, numbness or cold feeling in your arms and legs, nausea with vomiting, feeling very weak or tired.
Common Linezolid side effects may include:
vaginal itching or discharge;
constipation, mild diarrhea, mild nausea;
mild skin rash;
sleep problems (insomnia); or
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.
Side effects of Linezolid in details
Adult Patients: The safety of Linezolid formulations was evaluated in 2046 adult patients enrolled in 7 phase III comparator-controlled clinical trials who were treated for up to 28 days. In these studies, 85% of the adverse events reported with Linezolid were described as mild to moderate in intensity. Table 14 shows the incidence of adverse events reported in at least 2% of patients in these trials. The most common adverse events in patients treated with Linezolid were diarrhea (incidence across studies: 2.8-11%), headache (incidence across studies: 0.5-11.3%) and nausea (incidence across studies: 3.4-9.6%).
Other adverse events reported in phase II and phase III studies included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus and tongue discoloration.
Table 15 shows the incidence of drug-related adverse events reported in at least 1% of adult patients in these trials by dose of Linezolid.
Pediatric Patients: The safety of Linezolid formulations was evaluated in 215 pediatric patients ranging in age from birth through 11 years and in 248 pediatric patients 5-17 years (146 of these 248 were 5-11 years and 102 were 12-17 years). These patients were enrolled in 2 phase III comparator-controlled clinical trials and were treated for up to 28 days. In these studies, 83% and 99%, respectively, of the adverse events reported with Linezolid were described as mild to moderate in intensity. In the study of hospitalized pediatric patients (birth through 11 years) with gram-positive infections who were randomized 2:1 (Linezolid:vancomycin), mortality was 6% (13/215) in the Linezolid arm and 3% (3/101) in the vancomycin arm. However, given the severe underlying illness in the patient population, no causality could be established. Table 16 shows the incidence of adverse events reported in at least 2% of pediatric patients treated with Linezolid in these trials.
Table 17 shows the incidence of drug-related adverse events reported in >1% of pediatric patients (and >1 patient) in either treatment group in the comparator-controlled phase III trials.
Laboratory Changes: Linezolid has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hrs for up to 28 days. In phase III comparator-controlled trials, the percentage of adult patients who developed a substantially low platelet count (defined as <75% of lower limit of normal and/or baseline) was 2.4% (range among studies: 0.3-10%) with Linezolid and 1.5% (range among studies: 0.4-7%) with a comparator. In a study of hospitalized pediatric patients ranging in age from birth through 11 years, the percentage of patients who developed a substantially low platelet count (defined as <75% of lower limit of normal and/or baseline) was 12.9% with Linezolid and 13.4% with vancomycin. In an outpatient study of pediatric patients from 5-17 years, the percentage of patients who developed a substantially low platelet count was 0% with Linezolid and 0.4% with cefadroxil. Thrombocytopenia associated with the use of Linezolid appears to be dependent on duration of therapy (generally >2 weeks of treatment). The platelet counts for most patients returned to the normal range/baseline during the follow-up period. No related clinical adverse events were identified in phase III clinical trials in patients developing thrombocytopenia. Bleeding events were identified in thrombocytopenic patients in a compassionate use program for Linezolid; the role of Linezolid in these events cannot be determined.
Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between Linezolid and the comparators. These changes were generally not clinically significant, did not lead to discontinuation of therapy and were reversible. The incidence of adults and pediatric patients with at least 1 substantially abnormal hematologic or serum chemistry value is presented in Tables 18, 19, 20 and 21.
Post-Marketing Experience: Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported during post-marketing use of Linezolid. Peripheral neuropathy and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with Linezolid. Lactic acidosis has been reported with the use of Linezolid. Although these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days, these events have also been reported in patients receiving shorter courses of therapy. Serotonin syndrome has been reported in patients receiving concomitant serotonergic agents, including antidepressants eg, selective serotonin reuptake inhibitors (SSRIs) and Linezolid. Convulsions have been reported with the use of Linezolid. Superficial tooth discoloration and tongue discoloration have been reported with the use of Linezolid. The tooth discoloration was removable with professional dental cleaning (manual descaling) in case with known outcome. Anaphylaxis, angioedema and bullous skin disorders such as those described as Stevens-Johnson syndrome have been reported. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Linezolid or a combination of these factors. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made and causal relationship cannot be precisely established.
What is the most important information I should know about Linezolid?
- Linezolid suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Linezolid suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take Linezolid suspension before you receive any medical or dental care, emergency care, or surgery.
- Be sure to use Linezolid suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Linezolid suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take Linezolid suspension. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.
- Linezolid suspension may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Linezolid suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
- Lactic acidosis has occurred with the use of Linezolid suspension. Contact your doctor if you have severe or persistent nausea, vomiting, stomach pain, or unusual tiredness or weakness.
- Serious eye problems (eg, peripheral and optic neuropathy) have occurred with the use of Linezolid suspension. Contact your doctor if you experience vision changes (eg, decreased or blurred vision, changes in color vision, loss of vision).
- Phenylketonuria patients - Linezolid suspension contains phenylalanine. If you must have a diet that is low in phenylalanine, talk with your doctor or pharmacist.
- Diabetes patients - Low blood sugar has been reported in patients taking Linezolid suspension along with insulin or other diabetes medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Lab tests, including complete blood cell counts and eye exams, may be performed while you use Linezolid suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Linezolid suspension while you are pregnant. It is not known if Linezolid suspension is found in breast milk. If you are or will be breast-feeding while you use Linezolid suspension, check with your doctor. Discuss any possible risks to your baby.
Do not use Linezolid if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Many drugs can interact with Linezolid. Before using Linezolid, tell your doctor about all other medications you use. You may need to stop using certain medicines before using Linezolid (in some cases for up to 5 weeks before you start Linezolid). During your treatment with Linezolid, do not start or stop using any other medications unless your doctor tells you to.
You should not use Linezolid if you have untreated or uncontrolled high blood pressure, a carcinoid tumor, adrenal gland tumor, or a severely overactive thyroid.
If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.
Eating tyramine while you are using Linezolid can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as aged cheeses or meats, pickled or fermented meats, smoked or air-dried meats, sauerkraut, soy sauce, tap beer, red wine, or any meat, cheese, or other protein-based food that has been improperly stored.
- DailyMed. "LINEZOLID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "(S)-N-((3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "LINEZOLID". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Linezolid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Linezolid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effectsNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology