Get emergency medical help if you have signs of an allergic reaction to Ofloxacin: hives, or the first sign of a skin rash; fast heartbeat, 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 using Ofloxacin and call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
muscle pain or weakness;
a seizure (convulsions);
sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding, pale skin;
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);
nerve symptoms - numbness, weakness, tingling, burning, pain, or being more sensitive to temperature, light touch, or the sense of your body position;
changes in mood or behavior - depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;
liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
increased pressure inside the skull - severe headaches, ringing in your ears, vision problems, pain behind your eyes; or
severe skin reaction - skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Ofloxacin side effects may include:
nausea, constipation, diarrhea;
dizziness; or
headache.
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
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Ofloxacin: The following is a compilation of the data for Ofloxacin based on clinical experience with both the oral and IV formulations. The incidence of drug-related adverse reactions in patients during phase 2 and 3 clinical studies (conducted by innovator) was reported to be 11%. Among patients receiving multiple-dose therapy, 4% discontinued Ofloxacin due to adverse experiences.
In reported clinical studies, 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% and dysgeusia 1%.
In reported clinical studies, 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 reported clinical studies, the following events, regardless of relationship to drug, occurred in 1-3% 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, reported in clinical studies at a rate of <1%, regardless of relationship to drug, were: Body as a Whole: Asthenia, chills, malaise, extremity pain, pain, epistaxis.
Special Senses: Decreased hearing acuity, tinnitus and photophobia.
Urinary System: Dysuria, urinary frequency and retention.
The following laboratory abnormalities appeared in ≥1% 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.
Special Senses: Diplopia, nystagmus, blurred vision, disturbances of: Taste, smell, hearing and equilibrium, usually reversible following discontinuation.
Laboratory: Hematopoietic: Prolongation of prothrombin time.
Serum Chemistry: Acidosis, elevation of serum triglycerides, cholesterol, potassium, liver function tests including GGTP, LDH and bilirubin.
Urinary: Albuminuria, candiduria.
In reported 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.
Other reported adverse events includes fungal infection, enterocolitis (sometimes haemorrhagic), anorexia, paraesthesia, unsteady gait, increase in liver enzymes and/or bilirubin, disturbances of kidney function, acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure.
Crystalluria and cylindruria have been reported with other quinolones.
Ofloxacin OD: The overall frequency of adverse reactions from the clinical database is about 7%. The commonest events involved the gastrointestinal system (about 5%) and the nervous system (about 2%). The following provides a tabulation based on post-marketing experience with Ofloxacin where occasional represents a frequency of 0.1-1%, rare <0.1%, very rare <0.01% and isolated cases <0.01%.
Digestive and Liver Side Effects: Occasional:Nausea and vomiting, diarrhoea, abdominal pain, gastric symptoms, (diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic). Rare: Loss of appetite, increase in liver enzymes and/or bilirubin. Very Rare: Cholestatic jaundice, hepatic or severe liver damage may develop. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile). Even if Clostridium difficile is only suspected, administration of Ofloxacin should be discontinued immediately and appropriate treatment given. Drugs that inhibit peristalsis should not be administered in such cases.
Central Nervous System: Occasional: Headache, dizziness, sleep disorders, restlessness. Rare: Confusion, nightmares, anxiety, depression, hallucinations and psychotic reactions, drowsiness, unsteady gait and tremor (due to disorders of muscular coordination), neuropathy, numbness and paraesthesiae or hyperaesthesiae, visual disturbances, disturbances of taste and smell (including, in exceptional cases, loss of function) extrapyramidal symptoms. Very Rare: Convulsions, hearing disorders (including, in exceptional cases, loss of hearing). These reactions have occurred in some patients after the 1st dose of Ofloxacin; in such cases, discontinue treatment immediately.
Cardiovascular System: Tachycardia and a temporary decrease in blood pressure have been reported. Rare: Circulatory collapse (due to pronounced drop in blood pressure).
Haematological Side Effects: Very Rare: Anaemia, eosinophilia, reversible neutropenia, leucopenia (including agranulocytosis), thrombocytopenia, pancytopenia. Only in some cases are these due to bone marrow depression. In very rare cases, haemolytic anaemias may develop.
Renal Side Effects: Rare: Disturbances of kidney function. Isolated Cases: Acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure. Allergic and Skin Side Effects: Occasional: Skin rash, itching. Very Rare: Rash on exposure to strong sunlight, other severe skin reactions, hypersensitivity reactions, immediate or delayed, usually involving the skin (eg, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome and vasculitis) may occur. In exceptional circumstances, vasculitis can lead to skin lesions including necrosis and may also involve internal organs. There are rarely other signs of anaphylaxis eg, tachycardia, fever, dyspnoea, shock, angioneurotic oedema, vasculitic reactions, eosinophilia. In such cases, treatment should be discontinued immediately and where appropriate, supportive treatment given.
Isolated Cases: Pneumonitis.
Other Side Effects: Rare: Malaise. Very Rare: Excessive rise or fall in blood sugar levels, weakness, joint and muscle pains (in isolated cases, these may be symptoms of rhabdomyolysis). Isolated Cases: Tendon discomfort including inflammation and rupture of tendons (eg, the Achilles tendon) particularly in patients treated concurrently with corticosteroids. In the event of signs of inflammation of a tendon, treatment with Ofloxacin must be stopped immediately and appropriate treatment must be initiated for the affected tendon.
The possibility cannot be ruled out that Ofloxacin may trigger an attack of porphyria in predisposed patients.
Except in very rare instances (eg, isolated cases of smell, taste and hearing disorders), the adverse effects observed subsided after discontinuation of Ofloxacin.
Laboratory Value Alterations: Serum Alkaline Phosphatase, SGOT, SGPT and Lactate Dehydrogenase: Values may be increased during Ofloxacin treatment.
Urinary Opiates and Porphyrins: False positive results may occur.
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 contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Ofloxacin. These other medicines can make Ofloxacin much less effective when taken at the same time.
Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.
Do not share this medication with another person (especially a child), even if they have the same symptoms you have.
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References
DailyMed. "OFLOXACIN: 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).
DTP/NCI. "ofloxacin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
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-o... (accessed September 17, 2018).
Reviews
The 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.
User reports
1 consumer reported side effects
Did 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.
Users
%
It has side effects
1
100.0%
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