Side effects
Agitation blistering, peeling, or loosening of the skin blurred vision chills diarrhea dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fixed position of the eye heart stops hoarseness inability to move the eyes increased blinking or spasms of the eyelid large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs no pulse or blood pressure noisy breathing overactive reflexes pain or discomfort in the arms, jaw, back, or neck poor coordination pounding heartbeat red irritated eyes red skin lesions often with a purple center restlessness shivering slow or irregular breathing sore throat sores, ulcers, or white spots in the mouth or on the lips sticking out of the tongue sweating talking or acting with excitement you cannot control trembling or shaking trouble with speaking twitching unconscious uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressions vomiting A drug may have side effects in addition to the ones that are intended. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Dry mouth, general feeling of unease or illness, difficulty passing a bowel movement (stool), anxiety, irritability, shaking, and difficulty sleeping Pain in the arm, back, or jaw Chest pain, discomfort, tightness, or heaviness Cough Reduced Urination Difficulty Breathing Difficulty Swallowing Dry Mouth Increased Thirst Loss of Appetite Loss of Bladder Control Loss of Consciousness Changes in Mood Muscle Pain or Cramps Nausea or Vomiting Noisy breathing Numbness or Tingling in the Hands or Feet For medical guidance on side effects, contact your doctor. Any of the following side effects should be discussed with your doctor right away: Consult a medical professional if any of the following side effects persist, are bothersome, or if you have any questions about them: confusion fast heartbeat fever headache dizziness difficulty breathing less frequent urination, less urine produced, painful urination, and difficulty passing urine (dribbling). Speaking difficulties, drooling, loss of balance, control over muscles, a shuffling gait, stiffness in the limbs, and uncontrollable movements, particularly of the face, neck, and back Feeling of warmth hiccups redness of the face, neck, arms, and occasionally, upper chest redness of the skin Consult a healthcare professional if you experience any additional effects. Unknown prevalence Not as typical More information on Zofran (ondansetron): Side effects Drug interactions Dosage information Pregnancy or breastfeeding Reviews (211) Patient tips Drug images Compare alternatives Pricing & coupons Generic availability Drug class: 5HT3 receptor antagonists Patient resources Drug Information Zofran injection Zofran (Advanced Reading) Zofran (Ondansetron Injection) Zofran (Ondansetron Oral Solution) Zofran (Ondansetron Tablets) Other brands Zuplenz Professional resources Prescr more prevalent Some patients may also experience unlisted side effects. Rare Some side effects may occur that usually do not need medical attention. As your body gets used to the medication, these side effects may go away during treatment. Contact the FDA at 1-800-FDA-1088 to report side effects. (More Information) Zofran side effects
Interactions
Whenever a medical professional treats you, give them a list of all the medications you take. Ondansetron can cause dangerously high levels of serotonin to accumulate in your body while you are taking certain other medications, a condition known as "serotonin syndrome." Tell your doctor about all medicines you use, and those you start or stop using during your treatment. If you also use: This covers vitamins, herbal products, prescription and over-the-counter medications, and other drugs as well. This is not an exhaustive list, and ondansetron may interact with a wide variety of medications. When taken concurrently with other medications, such as antibiotics, antidepressants, heart rhythm medications, antipsychotics, and medications for cancer, malaria, HIV, or AIDS, Zofran can seriously harm your heart. Drug interactions for Zofran (more information) A narcotic (opioid) medication, a medication to treat depression, a medication to treat a psychiatric disorder, or a medicine to stop nausea and vomiting.
Contraindications
Drive carefully and abstain from operating machinery until you know how Zofran affects you. If you have long QT syndrome, a condition that raises the risk of developing an irregular heartbeat that could lead to fainting or sudden death, you should not take Zofran. Zofran can make you drowsy. Patients receiving Zofran have experienced ECG changes, including QT interval prolongation, which can conceal the signs of intestinal obstruction. Patients who are allergic to other selective 5-HT3 receptor antagonists have reported hypersensitivity (allergic) reactions, changes in heart rhythm, and other symptoms. Hypotension is one of the serious side effects of Zofran that has been reported. After chemotherapy or abdominal surgery, taking Zofran may mask the signs of an intestinal obstruction (abdominal ileus). A dangerously low blood pressure and loss of consciousness are possible side effects of taking Zofran and apomorphine (Apokyn) concurrently.
The researchers observed that out of the approximately 200,000 unique patients seen with this diagnostic code in 2020, about 16,000 were found to be positive. • The current COVID-19 pandemic has in the last 22 months infected more than 240 million individuals and caused more than 4.88 million COVID-19 deaths and these numbers are expected to escalate in coming weeks and months despite a mass vaccination program globally as newer more potent and immune evasive SARS-CoV-2 variants are emerging constantly. It further validates some already established factors associated with COVID-19 increased mortality, such as higher BUN, CRP, ferritin, and D-dimer levels. However, it is ineffective for treating vomiting caused by motion sickness. This novel approach generated causal networks that enabled unbiased identification of significant predictors of mortality for specific COVID-19 patient populations.
However, families allege use of the medication during pregnancy caused children to be born with severe birth defects and congenital malformations, such as cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems. The U.S. District Judge presiding over all Zofran birth defect lawsuits pending throughout the federal court system has scheduled the first bellwether trial to go before a jury in October 2021, which will help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of lawsuits filed by families nationwide. Given the similar questions of fact and law presented throughout the Zofran litigation, cases filed throughout the federal court system have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system. GlaxoSmithKline currently faces more than 400 product liability complaints filed in U.S. District Courts throughout the country, each involving allegations that women and the medical community were not adequately warned about the potential pregnancy risks with Zofran, an anti-nausea medication that has commonly been marketed for use to treat morning sickness.
This is an off-label use that may carry serious risks, including the possibility of having a child with a birth defect, including cleft palates, atrial septal defects (ASD) and ventricular septal defects (VSD). A 2012 study found that women who took ondansetron in the first trimester of pregnancy were 2.37x more likely to have a child with a cleft palate than women not taking the drug. An experienced pharmaceutical drug lawyer at the Michael Brady Lynch Firm may be able to help your family get justice. Call us today or fill out the form on this page to speak with us.
Other Zofran Birth Defects Multiple retrospective studies conducted in several countries, including the U.S. have shown that Zofran may increase the risk of other birth defects by as much as 34 percent. Pregnancy Category B indicates that the medication has not been proven safe for use in pregnancy but animal studies have not indicated toxicity. Many children with VSD may experience slow or inhibited physical and mental development. Many women or families of affected children have filed Zofran lawsuits related to birth defects caused by Zofran use and may be eligible for significant compensation for those injuries.
A series of orders are subsequently issued that, among other things, establish a Plaintiffs Steering Committe and will allow for the filing of cases directly in the District of Massachusetts. According to the meeting’s agenda, the Court will also hear arguments on GlaxoSmithKline’s motions for sequenced discovery and a protective order concerning certain plaintiffs’ deposition notices. Studies involving the medication have uncovered the following problems in some children whose mothers used the drug while they were pregnant: Birth defects Heart murmur Kidney defects Heart defects Atrial septal defect (“hole in the heart”) Cleft palate Cleft lip Fetal growth restriction (poor growth in the womb) Jaundice Life-threatening pregnancy complications Death The U.S. Food and Drug Administration (FDA) specifies on its Zofran prescribing information that it should not be used to treat pregnant women, even though reproduction studies have been performed in pregnant rats and rabbits at I.V.
June 2015 – A trial begins in Philadelphia involving a girl who was born with serious heart malformations after being exposed to Zoloft during pregnancy. July 2006 – The FDA adds a black box warning to the Depakote label warning consumers and the medical community that use of the anticonvulsant drug during pregnancy may cause birth defects in babies. July 2010 – A report from the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy indicates that babies exposed to Depakote and other valproate-based anticonvulsant drugs in pregnancy are more than twice as likely to suffer major birth defects.
Although Zofran is only approved for preventing nausea and vomiting for patients about to undergo chemotherapy or surgery, many medications are given off-label for other conditions. This medication carries a risk of causing slowed or stopped breathing in babies and toddlers. There are no research studies supporting that it works in this situation as all of the studies have been done in an emergency room setting.