How do you administer this medicine?
What are the possible side effects of Ofloxacin?
Get emergency medical help if you have any of these signs of an allergic reaction: hives, or the first sign of a skin rash; fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.
Ofloxacin may cause swelling or tearing of (rupture) a tendon. Ofloxacin can also have serious effects on your nerves, and may cause permanent nerve damage. Stop taking this medicine and call your doctor at once if you have:
signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions); or
nerve symptoms--numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position.
Stop using ofloxacin and call your doctor at once if you have:
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
muscle weakness or trouble breathing;
diarrhea that is watery or bloody;
sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding;
depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;
seizure (convulsions); or
increased pressure inside the skull-- severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Common side effects may include:
stomach discomfort, vomiting, mild diarrhea;
vaginal itching or discharge;
mild dizziness; 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 Ofloxacin in details
The following is a compilation of the data for Ofloxacin based on clinical experience with both the oral and intravenous formulations. The incidence of drug-related adverse reactions in patients during Phase 2 and 3 clinical trials was 11%. Among patients receiving multiple-dose therapy, 4% discontinued Ofloxacin due to adverse experiences.
In clinical trials, the following events were considered likely to be drug-related in patients receiving multiple doses of Ofloxacin:
nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1%, dysgeusia 1%.
In clinical trials, the most frequently reported adverse events, regardless of relationship to drug, were:
nausea 10%, headache 9%, insomnia 7%, external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%, vomiting 4%.
In clinical trials, the following events, regardless of relationship to drug, occurred in 1 to 3% of patients:
abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.
Additional events, occurring in clinical trials at a rate of less than 1%, regardless of relationship to drug, were:
The following laboratory abnormalities appeared in ≥ 1.0% of patients receiving multiple doses of Ofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated.
Postmarketing Adverse Events
Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including Ofloxacin:
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established.
CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with other quinolones.
What is the most important information I should know about Ofloxacin?
- Ofloxacin may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use ofloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Ofloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to ofloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Diabetes patients - Ofloxacin may affect your blood sugar when taken along with insulin or other medicines for diabetes. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Tell your doctor or dentist that you take ofloxacin before you receive any medical or dental care, emergency care, or surgery.
- Ofloxacin only works against bacteria; it does not treat viral infections (eg, the common cold).
- Long-term or repeated use of ofloxacin 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.
- If you experience pain or inflammation, or rupture a tendon during or shortly after taking ofloxacin, contact your health care provider immediately.
- 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.
- Nerve problems in the arms, hands, legs, or feet can happen in people taking ofloxacin. These nerve problems can happen soon after ofloxacin is started and may be permanent. Call your doctor right away if you have symptoms or nerve problems (eg, not able to handle heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet).
- Be sure to use ofloxacin 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.
- Lab tests, including kidney function, may be performed while you use ofloxacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use ofloxacin with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).
- Ofloxacin should not be used in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking ofloxacin while you are pregnant. Ofloxacin is found in breast milk. Do not breast-feed while taking ofloxacin.
Ofloxacin tablets are contraindicated in persons with a history of hypersensitivity associated with the use of Ofloxacin or any member of the quinolone group of antimicrobial agents.
- European Chemicals Agency - ECHA. "(+/-)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-on-ch... (accessed September 18, 2017).
- HSDB. "Ofloxacin". https://toxnet.nlm.nih.gov/cgi-bin/sis/s... (accessed September 18, 2017).
ReviewsThe results of a survey conducted on ndrugs.com for Ofloxacin 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 Ofloxacin. 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.
1 consumer reported side effectsDid you experience side effects while taking Ofloxacin drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Ofloxacin drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.