What are the possible side effects of Febrolito?
Get emergency medical help if you have signs of an allergic reaction to Febrolito: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using Febrolito and call your doctor at once if you have:
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changes in your vision;
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shortness of breath (even with mild exertion);
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swelling or rapid weight gain;
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the first sign of any skin rash, no matter how mild;
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
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low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, 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 Febrolito side effects may include:
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upset stomach, mild heartburn, nausea, vomiting;
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bloating, gas, diarrhea, constipation;
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dizziness, headache, nervousness;
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mild itching or rash; or
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ringing in your ears.
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 Febrolito in details
The pattern of adverse events reported for Febrolito is similar to that for other nonsteroidal anti-inflammatory drugs (NSAIDs).
Gastrointestinal Disorders: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, gastrointestinal hemorrhage and exacerbation of colitis and Crohn's disease have been reported following Febrolito administration. Less frequently, gastritis, duodenal and gastric ulcer, and gastrointestinal perforation have been observed.
A transient sensation of burning in the mouth or throat may occur with Febrolito syrup or Febrolito granules.
Immune System Disorders: Hypersensitivity reactions have been reported following treatment with Febrolito. These may consist of nonspecific allergic reaction and anaphylaxis; respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea; or assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Infections and Infestations: Exacerbation of infection-related inflammations (eg, development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Febrolito, the patient is therefore, recommended to go to a physician without delay.
Skin and Subcutaneous Tissue Disorders: In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.
Cardiac and Vascular Disorders: Clinical trial and epidemiological data suggest that use of Febrolito (particularly at high doses of 2,400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).
The following adverse reactions possibly related to Febrolito ad displayed by MedDRA frequency convention and system organ classification. Frequency groupings are classified according to the subsequent conventions: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Infections and Infestations: Uncommon: Rhinitis. Rare: Meningitis Aseptic.
Blood and Lymphatic System Disorders: Rare: Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia.
Immune System Disorders: Rare: Anaphylactic reaction.
Psychiatric Disorders: Uncommon: Insomnia, anxiety. Rare: Depression, confusional state.
Nervous System Disorders: Common: Headache, dizziness. Uncommon: Paraesthesia, somnolence. Rare: Optic neuritis.
Eye Disorders: Uncommon: Visual impairment. Rare: Toxic optic neuropathy.
Ear and Labyrinth Disorders: Uncommon: Hearing impairment, tinnitus, vertigo.
Respiratory, Thoracic and Mediastanal Disorders: Uncommon: Asthma, bronchospasm, dyspnoea.
Gastrointestinal Disorders: Common: Dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, hematemesis, gastrointestinal hemorrhage. Uncommon: Gastritis, duodenal and gastric ulcer, mouth ulceration, gastrointestinal perforation. Very Rare: Pancreatitis. Not Known: Colitis and Crohn's disease.
Hepatobiliary Disorders: Uncommon: Hepatitis, jaundice, abnormal hepatic function. Very Rare: Hepatic failure.
Skin and Subcutaneous Tissue Disorders: Common: Rash. Uncommon: Urticaria, pruritus, purpura, angioedema, photosensitivity reaction. Very Rare: Severe forms of skin reactions (eg, erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Renal and Urinary Disorders: Uncommon: Nephrotoxicity in various forms eg, tubulointerstitial nephritis, nephrotic syndrome and renal failure.
General Disorders and Administration Site Conditions: Common: Fatigue. Rare: Oedema.
Cardiac Disorders: Very Rare: Cardiac failure, myocardial infarction.
Vascular Disorders: Very Rare: Hypertension.
What is the most important information I should know about Febrolito?
- Febrolito drops may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Febrolito drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Febrolito drops. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Febrolito drops with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than 10 days without checking with your doctor.
- If stomach pain or upset gets worse or does not get better, check with the doctor. If pain or fever gets worse or lasts for more than 3 days, check with your doctor.
- If a child using Febrolito drops does not get any relief within 24 hours, contact the child's doctor.
- Febrolito drops has Febrolito in it. Before you start any new medicine, check the label to see if it has Febrolito in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Febrolito drops unless your doctor tells you to.
- Diabetes patients - Febrolito drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Use Febrolito drops with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.
- Different brands of Febrolito drops may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
- PREGNANCY and BREAST-FEEDING: Febrolito drops may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Febrolito drops while you are pregnant. It is not known if Febrolito drops is found in breast milk. Do not breast-feed while taking Febrolito drops.
Febrolito contraindications
This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Febrolito just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Febrolito, especially in older adults.
Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not take more of this medication than is recommended. An overdose of Febrolito can cause damage to your stomach or intestines. Use only the smallest amount of Febrolito needed to get relief from your pain, swelling, or fever.
References
- DailyMed. "IBUPROFEN: 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. "ibuprofen: 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. "Ibuprofen: 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 Febrolito 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 Febrolito. 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