Gelofen 400 Side effects

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What are the possible side effects of Gelofen 400?

Get emergency medical help if you have signs of an allergic reaction to Gelofen 400: 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 Gelofen 400 and call your doctor at once if you have:

  • changes in your vision;

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • 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);

  • kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • 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 Gelofen 400 side effects may include:

  • upset stomach, mild heartburn, nausea, vomiting;

  • bloating, gas, diarrhea, constipation;

  • dizziness, headache, nervousness;

  • mild itching or rash; or

  • 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 Gelofen 400 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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The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events
  • GI Bleeding, Ulceration and Perforation
  • Hepatotoxicity
  • Hypertension
  • Heart Failure and Edema
  • Renal Toxicity and Hyperkalemia
  • Anaphylactic reactions
  • Serious Skin Reactions
  • Hematologic Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Population

During clinical development, 560 patients were exposed to Gelofen 400, 438 in pain and 122 with fever. In the pain studies, Gelofen 400 was started intra-operatively and administered at a dose of 400 mg or 800 mg every six hours for up to three days. In the fever studies, Gelofen 400 was administered at doses of 100 mg, 200 mg, or 400 mg every four or six hours for up to 3 days. The most frequent type of adverse reaction occurring with oral Gelofen 400 is gastrointestinal.

Pain Studies

The incidence rates of adverse reactions listed in the following table were derived from multi-center, controlled clinical studies in post-operative patients comparing Gelofen 400 to placebo in patients also receiving morphine as needed for post-operative pain.

Table 1: Post-operative Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Gelofen 400 Treatment Group in Pain Studies*

Event Gelofen 400 Placebo

(N=287)

400 mg

(N=134)

800 mg

(N=304)

Any Reaction 118 (88%) 260 (86%) 258 (90%)
Nausea 77 (57%) 161 (53%) 179 (62%)
Vomiting 30 (22%) 46 (15%) 50 (17%)
Flatulence 10 (7%) 49 (16%) 44 (15%)
Headache 12 (9%) 35 (12%) 31 (11%)
Hemorrhage 13 (10%) 13 (4%) 16 (6%)
Dizziness 8 (6%) 13 (4%) 5 (2%)
Edema peripheral 1 ( < 1%) 9 (3%) 4 (1%)
Urinary retention 7 (5%) 10 (3%) 10 (3%)
Anemia 5 (4%) 7 (2%) 6 (2%)
Decreased hemoglobin 4 (3%) 6 (2%) 3 (1%)
Dyspepsia 6 (4%) 4 (1%) 2 ( < 1%)
Wound hemorrhage 4 (3%) 4 (1%) 4 (1%)
Abdominal discomfort 4 (3%) 2 ( < 1%) 0
Cough 4 (3%) 2 ( < 1%) 1 ( < 1%)
Hypokalemia 5 (4%) 3 ( < 1%) 8 (3%)
* All patients received concomitant morphine during these studies.

Fever Studies

Fever studies were conducted in febrile hospitalized patients with malaria and febrile hospitalized patients with varying causes of fever. In hospitalized febrile patients with malaria, the adverse reactions observed in at least two Gelofen 400-treated patients included abdominal pain and nasal congestion.

In hospitalized febrile patients (all causes), adverse reactions observed in more than two patients in any given treatment group are presented in the table below.

Table 2: Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Gelofen 400 Treatment Group in All-Cause Fever Study

Event Gelofen 400 Placebo

N=28

100 mg

N=30

200 mg

N=30

400 mg

N=31

Any Reaction 27 (87%) 25 (83%) 23 (74%) 25 (89%)
Anemia 5 (17%) 6 (20%) 11 (36%) 4 (14%)
Eosinophilia 7 (23%) 7 (23%) 8 (26%) 7 (25%)
Hypokalemia 4 (13%) 4 (13%) 6 (19%) 5 (18%)
Hypoproteinemia 3 (10%) 0 4 (13%) 2 (7%)
Neutropenia 2 (7%) 2 (7%) 4 (13%) 2 (7%)
Blood urea increased 0 0 3 (10%) 0
Hypernatremia 2 (7%) 0 3 (10%) 0
Hypertension 0 0 3 (10%) 0
Hypoalbuminemia 3 (10%) 1 (3%) 3 (10%) 1 (4%)
Hypotension 0 2 (7%) 3 (10%) 1 (4%)
Diarrhea 3 (10%) 3 (10%) 2 (7%) 2 (7%)
Pneumonia bacterial 3 (10%) 1 (3%) 2 (7%) 0
Blood LDH increased 3 (10%) 2 (7%) 1 (3%) 1 (4%)
Thrombocythemia 3 (10%) 2 (7%) 1 (3%) 0
Bacteremia 4 (13%) 0 0 0

Pediatric Population

A total of 143 pediatric patients ages 6 months and older have received Gelofen 400 in controlled clinical trials. The most common adverse reactions (incidence greater than or equal to 2%) in pediatric patients treated with Gelofen 400 were infusion site pain, vomiting, nausea, anemia and headache.

What is the most important information I should know about Gelofen 400?

  • Gelofen 400 drops may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Gelofen 400 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 Gelofen 400 drops. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Gelofen 400 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 Gelofen 400 drops does not get any relief within 24 hours, contact the child's doctor.
  • Gelofen 400 drops has Gelofen 400 in it. Before you start any new medicine, check the label to see if it has Gelofen 400 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 Gelofen 400 drops unless your doctor tells you to.
  • Diabetes patients - Gelofen 400 drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Use Gelofen 400 drops with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.
  • Different brands of Gelofen 400 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: Gelofen 400 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 Gelofen 400 drops while you are pregnant. It is not known if Gelofen 400 drops is found in breast milk. Do not breast-feed while taking Gelofen 400 drops.

Gelofen 400 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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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 Gelofen 400 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 Gelofen 400, 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 Gelofen 400 can cause damage to your stomach or intestines. Use only the smallest amount of Gelofen 400 needed to get relief from your pain, swelling, or fever.


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References

  1. 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).
  2. 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).
  3. 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 Gelofen 400 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 Gelofen 400. 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

5 consumers reported side effects

Did you experience side effects while taking Gelofen 400 drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Gelofen 400 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 effects3
60.0%
No side effects2
40.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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