What Are Side Effects Associated with Using I-Gesic?
Side effects associated with use of I-Gesic, include the following:
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Rated I-Gesic for Pain Report
Started taking this for serious knee pain. 3 days in feeling very nauseous, really bad upset stomach, also bloody stool.
2. Key facts
- Take I-Gesic tablets or capsules with a meal or snack, or just after eating.
- It's best to take the lowest dose of I-Gesic for the shortest time to control your symptoms.
- The most common side effects are headaches, dizziness, stomach pain, feeling or being sick, diarrhoea and rashes.
- I-Gesic tablets come as either I-Gesic potassium or I-Gesic sodium. They work as well as each other.
- I-Gesic is also called by the brand names Voltarol, Dicloflex, Econac and Fenactol.
Pregnancy and I-Gesic
Because risk of damage to the unborn child varies during pregnancy, I-Gesic falls under two FDA pregnancy categories:
- In the first 29 weeks of pregnancy, I-Gesic has a category C rating: There is a risk of harm to the fetus, but it has not yet been confirmed in humans.
- During or after the 30th week of pregnancy, I-Gesic has a category D rating: In this case, the drug can cause a birth defect by causing a major artery to close that nourishes the baby’s heart. So you should only take I-Gesic if there are no other safer options available.
Regardless, you should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.
You should also alert your physician if you are breastfeeding or plan to breastfeed. I-Gesic is found in breast milk, and mothers should avoid taking this drug while nursing.
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as I-Gesic, increases the risk of serious gastrointestinal (GI) events (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).
I-Gesic is a nonsteroidal anti-inflammatory drug (NSAID). Don’t combine it with other NSAIDs unless directed by your doctor, as this may increase your risk of stomach and bleeding issues. Examples of other NSAIDs include:
Taking digoxin with I-Gesic can lead to increased levels of digoxin in your body and increased side effects. Your doctor may monitor your digoxin levels closely.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
This drug comes with several warnings.
Q: What are the side effects of I-Gesic?
A: I-Gesic is a medication in the NSAID family of drugs that is used to treat pain caused by inflammation. I-Gesic is used to treat a variety of conditions including arthritis, migraines, and joint pain. The prescribing information on I-Gesic lists the following as the most common side effects of the medication: stomach pain constipation or diarrhea heartburn gas nausea/vomiting dizziness swelling ringing of the ears. Some side effects that you should report to your physician include: slurred speech confusion weakness shortness of breath high blood pressure dark, tarry stools dark urine yellowing of the skin or eyes rapid weight gain or unusual swelling of the hands, feet or ankles. Lori Poulin, PharmD
4. How and when to use them
You'll usually take I-Gesic tablets, capsules or suppositories 2 to 3 times a day.
The standard dose is 75mg to 150mg a day, depending on what your doctor prescribes for you. Follow your doctor's advice on how many tablets to take, and how many times a day.
If your doctor prescribes I-Gesic for your child, they'll use your child's weight to work out the right dose for them.
If you have pain all the time, your doctor may recommend slow-release I-Gesic tablets or capsules. It's usual to take these either once a day in the evening, or twice a day.
If you're taking slow-release I-Gesic twice a day, leave a gap of 10 to 12 hours between your doses.
Outcome and Management
Severity of the liver injury ranges from asymptomatic elevations in serum aminotransferase levels (Cases 1 and 2), to overt icteric hepatitis (Case 3), acute liver failure and even death (Case 4). Complete recovery is expected after stopping the drug and usually takes 1 to 3 months. In rare instances, evidence of chronic liver injury persists, some of which have led to courses of corticosteroid therapy which appeared to be beneficial and could later be stopped without recurrence of liver injury. Acute liver failure following rechallenge after episodes of clinically apparent I-Gesic hepatotoxicity has been reported and should be avoided. There is little evidence of cross sensitivity to hepatic injury between I-Gesic and NSAIDs belonging to other classes, such as the propionic acids (ibuprofen, naproxen, ketoprofen), but few instances documenting safety have been reported and patients should be carefully monitored if switched to another NSAID.
I-Gesic (Voltaren, Cataflam, Voltaren-XR, Cambia) is a nonsteroidal anti-inflammatory medication prescribed to treat inflammation and pain caused by conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and menstrual cramps. Side effects, drug interactions, dosage, and pregnancy safety should be reviewed prior to taking this medication.
Before taking this medicine
I-Gesic can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
I-Gesic may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
You should not use I-Gesic if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Do not use Cambia to treat a cluster headache. Do not use Zipsor if you are allergic to beef or beef protein.
To make sure I-Gesic is safe for you, tell your doctor if you have:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
liver or kidney disease;
Taking I-Gesic during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether I-Gesic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
I-Gesic is not approved for use by anyone younger than 18 years old.
Generic Name: I-Gesic (dye KLOE fen ak)Brand Names: Cambia, Cataflam, Voltaren-XR, Zipsor, Zorvolex, Voltaren, Dyloject
Medically reviewed by Kaci Durbin, MD Last updated on Jan 18, 2019.
Difference between I-Gesic and Ibuprofen
Both drugs are classified as NSAID – nonsteroidal anti-inflammatory drugs and used with efficacy for the treatment of pain. They work by lowering the levels of hormones (prostaglandins) that are responsible for causing inflammation and pain in the body.
I-Gesic sodium administered to male and female rats at 4 mg/kg/day (approximately 0.2 times the MRHD based on BSA comparison) did not affect fertility.
Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including VOLTAREN, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including VOLTAREN, in women who have difficulties conceiving or who are undergoing investigation of infertility.
Prescribed for Back Pain, Frozen Shoulder, Ankylosing Spondylitis, Aseptic Necrosis, Migraine, Spondyloarthritis, Muscle Pain, Osteoarthritis, Pain, Period Pain, Rheumatoid Arthritis, Sciatica.
I-Gesic may also be used for purposes not listed in this medication guide.
Prescribed for Back Pain, Chronic Myofascial Pain, Costochondritis, Aseptic Necrosis, Headache, Muscle Pain, Fever, Patent Ductus Arteriosus, Gout - Acute, Radiculopathy, Polymyalgia Rheumatica, Sciatica, Rheumatoid Arthritis, Spondylolisthesis, Temporomandibular Joint Disorder, Toothache, Plantar Fasciitis, Neck Pain, Period Pain, Pain, Osteoarthritis, Juvenile Rheumatoid Arthritis, Frozen Shoulder, Eustachian Tube Dysfunction, Dysautonomia, Diffuse Idiopathic Skeletal Hyperostosis, Transverse Myelitis.
May also be prescribed off label for Herniated Disk.
Common Side Effects of I-Gesic:
Although these side effects of I-Gesic are more common, they may be very serious. Stop taking I-Gesic and tell your doctor right away if you have any of the following symptoms:
- Stomach problems, including gas, bloating, pain, cramping, constipation, and diarrhea
- Upset stomach and/or bleeding in your stomach, esophagus, or intestines
- Headache and ringing in the ears
People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as I-Gesic may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as I-Gesic if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take I-Gesic right before or right after the surgery.
NSAIDs such as I-Gesic may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking I-Gesic. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking I-Gesic and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to I-Gesic. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with I-Gesic and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Tablets and capsules
Swallow the I-Gesic tablets or capsules with a glass of water or milk. Swallow them whole - do not crush, break or chew them.
Always take your I-Gesic tablets or capsules after a meal or snack, or with a drink of milk. They'll be less likely to upset or irritate your stomach.
Mechanism of Injury
The mechanism of I-Gesic induced liver injury appears to be multifactorial, and the cause of mild serum aminotransferase elevations may be different from the cause of serious liver injury. An immuno-allergic component is suggested by the rapid and acute recurrence of injury, even many years after initial exposure and injury. Genetic studies have suggested a linkage with allelic varriants of UGT 2B7, CYP 2C8 and ABC C2, which are genes involved the metabolism, conjugation and excretion of I-Gesic.
Serious Side Effects
Stop taking I-Gesic and get immediate medical attention if you experience any of the following:
- Liver damage or inflammation of the liver (watch for yellowing or graying of the skin or eyes, swelling of the abdomen or lower extremities)
- Low blood pressure (one sign of low blood pressure is dizziness when getting up to stand)
- Blood disorders, such as low platelet count, decreased hemoglobin, and decreased bone marrow activity
- Congestive heart failure (watch for swelling in your lower limbs, shortness of breath, trouble walking normal distances’, extra tiredness)
- Severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (tell your doctor about any skin abnormalities; get emergency medical help right away if you have any dramatic or severe skin reactions)