Zofran® Side Effects

Zofran Side Effects

Patients have reported many different types of Zofran side effects.

In clinical trials comparing Zofran to placebo, the following principal Zofran side effects were reported:

  • Constipation
  • Diarrhea
  • Dizziness
  • Headache
  • Malaise/fatigue

Other common Zofran side effects include fever, lightheadedness, drowsiness, rash, blurred vision and muscle spasm.

In addition to adverse effects reported during clinical trials, the label lists other Zofran side effects that have been reported during clinical practice since the drug received FDA approval.

According to the label, these effects were “chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Zofran.”

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The Zofran label lists:

  • “transient ECG [electrocardiogram] changes” that indicate a disruption of the heart’s normal rhythm.
  • A particularly dangerous rapid heart rhythm known as torsades de pointes has been reported in patients taking ondansetron.
  • Oculogyric crisis – a prolonged involuntary upward deviation of the eyes.
  • Liver enzyme abnormalities.
  • Cases of transient blindness.
  • Severe allergic reactions, including anaphylaxis and shortness of breath.

Symptoms of serotonin syndrome include:

  • Agitation
  • Delirium
  • Dizziness
  • Muscle rigidity
  • Nausea
  • Possible death
  • Seizures
  • Tremors
  • Vomiting

Zofran® Birth Defects

Zofran has been linked to a wide range of birth defects, both in the medical literature and in reports made directly to the maker of the drug, GlaxoSmithKline.

According to court filings, GlaxoSmithKline has received hundreds of reports of birth defects associated with first trimester fetal exposure to Zofran. The birth defects reported include:

  • Congenital diaphragmatic anomaly (abnormality)
  • Congenital heart disease
  • Congenital musculoskeletal anomalies
  • Intrauterine death
  • Kidney malformation
  • Malformations of the body
  • Orofacial anomalies
  • Stillbirth

Please contact our law firm if you took Zofran while pregnant and your child has any of the following birth defects or conditions:

  • Abdominal Birth Defects / Omphalocele
  • Anal atresia (complete or partial closure of the anus
  • Cardiac (heart) defects
  • Cleft palate or cleft lip
  • Clubfoot (one or both feet turn downward and inward)
  • Craniosynostosis (skull defect)
  • Limb Defects
  • Neural-tube defects (brain and spinal cord, spina bifida)
  • PPHN (Persistent Pulmonary Hypertension of the Newborn)

Research studies in 2013 and 2014 have reported that Zofran is associated with a doubling of the risk of cleft palate, as well as significant increases in the risk of defects related to the development of the heart and the aorta. Among the major malformations reported in one study are the following:

  • Atrium septal defect – a hole in the wall between the heart’s two upper chambers.
  • Cauda equina malformation – a defect that affects the nerves located at the lower end of the spinal cord.
  • Coarctation of the aorta – a narrowing of the aorta.
  • Combined ventricular and atrium septal defect – a hole between the two upper chambers (atria) and a hole between the two lower chambers (ventricles) of the heart occurring at the same time.
  • Esophageal atresia – the upper esophagus is not connected to the lower esophagus and stomach; the lower esophagus connects to the windpipe.
  • Malformations of the – anus, intestines, colon, or urinary tract.
  • Polydactyly fingers – one or more extra fingers.
  • Pyloric stenosis – a narrowed opening between the stomach and the small intestine.
  • Tracheomalacia – weakness in the walls of the windpipe (trachea) that causes breathing difficulties.
  • Ventricular septal defect – a hole in the wall that separates the heart’s lower chambers.