What are the possible side effects of Ofloxacina Merck?
Get emergency medical help if you have signs of an allergic reaction to Ofloxacina Merck: hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.
Ofloxacina Merck may cause swelling or tearing of (rupture) a tendon. Ofloxacina Merck can also have serious effects on your nerves, and may cause permanent nerve damage.
Stop using Ofloxacina Merck and call your doctor at once if you have:
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severe stomach pain, diarrhea that is watery or bloody;
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headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
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muscle pain or weakness;
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a seizure (convulsions);
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sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding, pale skin;
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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);
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nerve symptoms - numbness, weakness, tingling, burning, pain, or being more sensitive to temperature, light touch, or the sense of your body position;
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changes in mood or behavior - depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;
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liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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increased pressure inside the skull - severe headaches, ringing in your ears, vision problems, pain behind your eyes; or
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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 Ofloxacina Merck side effects may include:
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nausea, constipation, diarrhea;
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dizziness; or
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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 Ofloxacina Merck in details
Subjects with Otitis Externa
In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacina Merck otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.
An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both Ofloxacina Merck and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.
In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.
In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.
Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes
In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with Ofloxacina Merck otic solution:
Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.
Post-marketing Adverse Events
Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Ofloxacina Merck otic solution 0.3% is unknown.
What is the most important information I should know about Ofloxacina Merck?
- Ofloxacina Merck drops may cause blurred vision. Use Ofloxacina Merck drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly.
- Tell your doctor or dentist that you take Ofloxacina Merck drops before you receive any medical or dental care, emergency care, or surgery.
- Be sure to use Ofloxacina Merck drops 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.
- Do not use Ofloxacina Merck drops for future eye problems unless directed by your doctor.
- Ofloxacina Merck drops should not be used in CHILDREN younger than 1 year old; 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 using Ofloxacina Merck drops while you are pregnant. It is not known if Ofloxacina Merck drops is excreted in breast milk. Do not breast-feed while taking Ofloxacina Merck drops.
Ofloxacina Merck contraindications
You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofloxacina Merck or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ofloxacina Merck, 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 Ofloxacina Merck. These other medicines can make Ofloxacina Merck much less effective when taken at the same time.
Ofloxacina Merck 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 Ofloxacina Merck 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.
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 Ofloxacina Merck 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 Ofloxacina Merck. 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
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
