Zofran ODT Side Effects

Generic Name: ondansetron

Note: This page contains side effects data for the generic drug ondansetron. It is possible that some of the dosage forms included below may not apply to the brand name Zofran ODT.

It is possible that some side effects of Zofran ODT may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ondansetron: film, solution, tablet, tablet disintegrating

Other dosage forms:

As well as its needed effects, ondansetron (the active ingredient contained in Zofran ODT) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ondansetron, check with your doctor immediately:

More common
  • Confusion
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • shortness of breath
  • weakness
Less common
  • Decrease in the frequency of urination
  • decrease in the urine volume
  • difficulty with passing urine (dribbling)
  • painful urination
Rare
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • convulsions
  • cough
  • decreased urine
  • difficulty with breathing
  • difficulty with swallowing
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • loss of appetite
  • loss of bladder control
  • loss of consciousness
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • noisy breathing
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • sweating
  • tightness in the chest
  • total body jerking
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Blurred vision
  • 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 breathing
  • no pulse or blood pressure
  • noisy breathing
  • pounding heartbeat
  • slow or irregular breathing
  • sticking out of the tongue
  • sweating
  • trouble with speaking
  • unconscious
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions

Some ondansetron side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Anxiety
  • difficulty having a bowel movement (stool)
  • dry mouth
  • general feeling of discomfort or illness
  • hyperventilation
  • irritability
  • restlessness
  • shaking
  • trouble sleeping
Rare
  • Difficulty with speaking
  • drooling
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Incidence not known
  • Feeling of warmth
  • hiccups
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • welts

For Healthcare Professionals

Applies to ondansetron: injectable solution, intravenous solution, oral disintegrating strip, oral solution, oral tablet, oral tablet disintegrating

General

In general, headache is the most common adverse effect reported. Transient dizziness during or shortly after the IV infusion has also been reported during postmarketing experience.[Ref]

Gastrointestinal

A causal relationship between intestinal obstruction and ondansetron (the active ingredient contained in Zofran ODT) has not been established.[Ref]

Gastrointestinal side effects including constipation (up to 15%) and diarrhea have been reported. Several cases of intestinal obstruction have been reported. Nausea and vomiting have been reported with the use of intravenous ondansetron during postmarketing experience.[Ref]

Hepatic

Hepatic side effects have included mild elevations of liver function tests. The clinical significance of these elevations is unknown. Cases of jaundice have also been reported rarely. One case of pancreatitis was reported in a patient using ondansetron (the active ingredient contained in Zofran ODT) long-term. Liver failure and death have been reported in patients with cancer receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics, and intravenous ondansetron during postmarketing experience.[Ref]

Cardiovascular

Cardiovascular side effects have rarely included angina and acute myocardial ischemia. Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT interval prolongation, and ST segment depression), palpitations, syncope, Torsade de points, ventricular fibrillation, and chest discomfort have been reported with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.[Ref]

One study has suggested that prolongation of the QTc interval may occur in many patients treated with cisplatin and ondansetron simultaneously. In that study QTc prolongation occurred in 6 of 8 patients who received a combination of ondansetron and cisplatin. Five of the patients had prolongations of the QTc interval which were greater than 5%. However, no episodes of arrhythmia, hypotension, ischemia, congestive heart failure or other cardiovascular events were observed.

Similarly, results of a review of the cardiovascular effects of the drug class 5-hydroxytryptamine 3 receptor antagonists in the literature reported that electrocardiographic (ECG) changes were so small to be considered clinically insignificant. ECG changes were most noticeable between 1 to 2 hours after a dose of ondansetron and returned to baseline within 24 hours. To date, no serious cardiac side effects (including torsades de pointes) triggered by ECG interval changes have been connected with the use of 5-HT 3 receptor antagonists.[Ref]

Hypersensitivity

Hypersensitivity side effects have rarely included rashes. Twenty-four reports of anaphylactoid-anaphylactic reactions following intravenous administration of ondansetron (the active ingredient contained in Zofran ODT) have been reported in postmarketing experience. One report suggests hypersensitivity reactions with 5-HT 3-antagonists may be a class effect and cross-reactive.[Ref]

Psychiatric

Psychiatric side effects have rarely included depression.[Ref]

A brief episode of ondansetron-induced depression has been reported in one woman whose depression was controlled with fluoxetine. A 41-year-old woman became suicidally depressed seven days after receiving ondansetron prior to arthroscopy. The depression was controlled with fluvoxamine, alprazolam, and flunitrazepam.[Ref]

Dermatologic

Dermatologic side effects have included pruritus (5%) and rash (1%). A suspected fixed drug eruption with the lesions appearing macular and pruritic has also been reported. Rechallenge lead to regression of the lesions. Urticaria, hyperhidrosis, pruritus, and purpura have been reported with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.
Postmarketing reports: Stevens-Johnson syndrome and toxic epidermal necrolysis[Ref]

Nervous system

Nervous system side effects have included dizziness (18%) and extrapyramidal reactions, including twitching tremors, opisthotonos, severe jerking movements, and numbness. In many of these cases, diphenhydramine (25 mg to 50 mg) was effective for treatment or prevention. Chills, lethargy, and oculogyric crisis, appearing alone, as well as with other dystonic reactions have also been reported with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.[Ref]

Rechallenge with ondansetron lead to a reoccurrence of the opisthotonos in one patient. Patients with a history of drug-induced dystonic reactions may have a similar response after ondansetron therapy.[Ref]

Ocular

Ocular side effects have rarely included blurred vision, in some cases associated with abnormalities of accommodation. Rare cases of transient blindness have also been reported, predominantly during intravenous administration.[Ref]

Transient blindness (a duration of 2 to 3 minutes) generally resolved within 20 minutes up to 48 hours.[Ref]

Respiratory

Respiratory side effects have included hiccups with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.[Ref]

Local

Local side effects have included pain, redness, and burning at injection site with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia reported with the use of intravenous ondansetron (the active ingredient contained in Zofran ODT) during postmarketing experience.[Ref]

References

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2. "Product Information. Zofran (ondansetron)." Cerenex Pharmaceuticals, Research Triangle Pk, NC.

3. "Product Information. Zuplenz (ondansetron)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.

4. Beck TM, Ciociola AA, Jones SE, Harvey WH, Tchekmedyian NS, Chang A, Galvin D, Hart NE "Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. The Ondansetron Study Group." Ann Intern Med 118 (1993): 407-13

5. Abdul-Ghaffar NU, el-Sonbaty MR "Pancreatitis and rhabdomyolysis associated with lovastatin-gemfibrozil therapy." J Clin Gastroenterol 21 (1995): 340-1

6. Bryson JC "Clinical safety of ondansetron." Semin Oncol 19 (1992): 26-32

7. Finn AL "Toxicity and side effects of ondansetron." Semin Oncol 19 (1992): 53-60

8. Navari RM, Madajewicz S, Anderson N, Tchekmedyian NS, Whaley W, Garewal H, Beck TM, Chang AY, Greenberg B, Caldwell KC, Huffm "Oral ondansetron for the control of cisplatin-induced delayed emesis: a large, multicenter, double-blind, randomized comparative trial of ondansetron versus placebo." J Clin Oncol 13 (1995): 2408-16

9. Albertiflor JJ "Pancreatitis associated with ondansetron." J Natl Cancer Inst 87 (1995): 689-90

10. Verrill M, Judson I "Jaundice with ondansetron." Lancet 344 (1994): 190-1

11. Palmer JB, Greenstreet YL "Ondansetron and chest pain." Lancet 340 (1992): 1410

12. Lifsey DS, Gralla RJ, Clark RA, Kline RC "Electrocardiographic changes with serotonin antagonist antiemetics: rate of occurrence and clinical relevance (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 12 (1993): A1611

13. Bosek V, Hu P, Robinson LA "Acute myocardial ischemia after administration of ondansetron hydrochloride." Anesthesiology 92 (2000): 885-7

14. Navari RM, Koeller JM "Electrocardiographic and cardiovascular effects of the 5-hydroxytryptamine(3) receptor antagonists." Ann Pharmacother 37 (2003): 1276-86

15. Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J "Prolongation of QTc Interval after Postoperative Nausea and Vomiting Treatment by Droperidol or Ondansetron." Anesthesiology 102 (2005): 1094-1100

16. Kataja V, Debruijn KM "Hypersensitivity reactions associated with 5-hydroxytryptamine(3)-receptor antagonists: a class effect?" Lancet 347 (1996): 584-5

17. Kossey JL, Kwok KK "Anaphylactoid reactions associated with ondansetron." Ann Pharmacother 28 (1994): 1029-30

18. Chen M, Tanner A, Gallotorres H "Anaphylactoid-anaphylactic reactions associated with ondansetron." Ann Intern Med 119 (1993): 862

19. Weiss KS "Anaphylactic reaction to ondansetron." Arch Intern Med 161 (2001): 2263

20. Chen M, Tanner A, Gallo-Torres H "Anaphylactoid-anaphylactic reactions associated with ondansetron." Ann Intern Med 119 (1993): 862

21. Blaine EM "Acute severe depression following peri-operative ondansetron." S Afr Med J 87 (1997): 1013-4

22. Oren DA "Dysphoria after treatment with ondansetron." Am J Psychiatry 152 (1995): 1101

23. Iglesias ME, Espana A, Redondo P, Quintanilla E "Fixed drug eruption secondary to ondansetron." Dermatology 191 (1995): 270-1

24. Stonell C "An extrapyramidal reaction to ondansetron." Br J Anaesth 81 (1998): 658

25. Ritter MJ, Goodman BP, Sprung J, Wijdicks EF "Ondansetron-induced multifocal encephalopathy." Mayo Clin Proc 78 (2003): 1150-2

26. Matthews HG, Tancil CG "Extrapyramidal reaction caused by ondnsetron." Ann Pharmacother 30 (1996): 196

27. Garcia-del-Muro X, Cardenal F, Ferrer P "Extrapyramidal reaction associated with ondansetron ." Eur J Cancer 29A (1993): 288

28. Sprung J, Choudhry FM, Hall BA "Extrapyramidal reactions to ondansetron: cross-reactivity between ondansetron and prochlorperazine?" Anesth Analg 96 (2003): 1374-6

29. Rust M, Cohen LA "Single oral dose ondansetron in the prevention of postoperative nausea and emesis." Anaesthesia 49 (1994): 16-23

30. Abali H, Celik I "Tropisetron, Ondansetron, and Granisetron for Control of Chemotherapy-Induced Emesis in Turkish Cancer Patients: A Comparison of Efficacy, Side-Effect Profile, and Cost." Cancer Invest 25 (2007): 135-139

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32. Navari RM, Province WS, Perrine GM, Kilgore JR "Comparison of intermittent ondansetron versus continuous infusion metoclopramide used with standard combination antiemetics in control of acute nausea induced by cisplatin chemotherapy." Cancer 72 (1993): 583-6

33. Marty M, Pouillart P, Scholl S, et al. "Comparison of the 5-hydroxytryptamine (serotonin) antagonist ondansetron (GR 38032F) with high-dose metoclopramide in the control of cisplantin-induced emesis." N Engl J Med 322 (1990): 816-21

34. Tolan MM, Fuhrman TM, Tsueda K, Lippmann SB "Perioperative extrapyramidal reactions associated with ondansetron." Anesthesiology 90 (1999): 340-1

35. Ruff P, Paska W, Goedhals L, et al. "Ondansetron compared with granisetron in the prophylaxis of cisplatin-induced acute emesis - a multicentre double-blind, randomised, parallel-group study." Oncology 51 (1994): 113-8

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