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Zofran (Ondansetron) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ZOFRAN. A causal relationship to therapy with ZOFRAN has been unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting

The adverse events in Table 5 have been reported in ≥5% of adult patients receiving a single 24-mg ZOFRAN Tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥50 mg/m2).

Table 5. Principal Adverse Events in US Trials: Single Day Therapy With 24-mg ZOFRAN Tablets (Highly Emetogenic Chemotherapy)

Event

Ondansetron

24 mg q.d.

n = 300

Ondansetron

8 mg b.i.d.

n = 124

Ondansetron

32 mg q.d.

n = 117

Headache

33 (11%)

16 (13%)

17 (15%)

Diarrhea

13 (4%)

9 (7%)

3 (3%)

The adverse events in Table 6 have been reported in ≥5% of adults receiving either 8 mg of ZOFRAN Tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens.

Table 6. Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg ZOFRAN Tablets (Moderately Emetogenic Chemotherapy)

Event

Ondansetron 8 mg b.i.d.

n = 242

Ondansetron 8 mg t.i.d.

n = 415

Placebo

n = 262

Headache

58 (24%)

113 (27%)

34 (13%)

Malaise/fatigue

32 (13%)

37 (9%)

6 (2%)

Constipation

22 (9%)

26 (6%)

1 (<1%)

Diarrhea

15 (6%)

16 (4%)

10 (4%)

Dizziness

13 (5%)

18 (4%)

12 (5%)

Central Nervous System

There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.

Hepatic

In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ZOFRAN Tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined.

There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Integumentary

Rash has occurred in approximately 1% of patients receiving ondansetron.

Other

Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ZOFRAN was unclear.

Radiation-Induced Nausea and Vomiting

The adverse events reported in patients receiving ZOFRAN Tablets and concurrent radiotherapy were similar to those reported in patients receiving ZOFRAN Tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.

Postoperative Nausea and Vomiting

The adverse events in Table 7 have been reported in ≥5% of patients receiving ZOFRAN Tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 7. Frequency of Adverse Events From Controlled Studies With ZOFRAN Tablets (Postoperative Nausea and Vomiting)


Adverse Event

Ondansetron 16 mg

(n = 550)

Placebo

(n = 531)

Wound problem

152 (28%)

162 (31%)

Drowsiness/sedation

112 (20%)

122 (23%)

Headache

49 (9%)

27 (5%)

Hypoxia

49 (9%)

35 (7%)

Pyrexia

45 (8%)

34 (6%)

Dizziness

36 (7%)

34 (6%)

Gynecological disorder

36 (7%)

33 (6%)

Anxiety/agitation

33 (6%)

29 (5%)

Bradycardia

32 (6%)

30 (6%)

Shiver(s)

28 (5%)

30 (6%)

Urinary retention

28 (5%)

18 (3%)

Hypotension

27 (5%)

32 (6%)

Pruritus

27 (5%)

20 (4%)

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ZOFRAN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ZOFRAN.

Cardiovascular

Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported.

General

Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron.

Hepatobiliary: Liver enzyme abnormalities

Lower Respiratory: Hiccups

Neurology : Oculogyric crisis, appearing alone, as well as with other dystonic reactions

Skin: Urticaria

Special Senses: Eye Disorders : Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.



REPORTS OF SUSPECTED ZOFRAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Zofran. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zofran side effects / adverse reactions in 25 year old male

Reported by a lawyer from France on 2011-10-04

Patient: 25 year old male

Reactions: Photosensitivity Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Emend
    Administration route: Oral
    Start date: 2011-07-08
    End date: 2011-07-08

Emend
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-13

Valacyclovir Hydrochloride
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Amikacin
    Start date: 2011-07-11
    End date: 2011-07-12

Vfend
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Zofran
    Start date: 2011-07-08
    End date: 2011-07-13

Evoltra
    Start date: 2011-07-08
    End date: 2011-07-12

Tramadol HCL
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-12

Piperacillin and Tazobactam
    Start date: 2011-07-11
    End date: 2011-07-12

Cytarabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-08
    End date: 2011-07-12

Ciprofloxacin
    Start date: 2011-07-13
    End date: 2011-07-15

Other drugs received by patient: Pentacarinat; Hydrea; Bactrim; Fasturtec; Tienam; Targocid



Possible Zofran side effects / adverse reactions in 25 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-10

Patient: 25 year old male

Reactions: Photosensitivity Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Vfend
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Evoltra
    Start date: 2011-07-08
    End date: 2011-07-12

Tramadol HCL
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-12

Cytarabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-08
    End date: 2011-07-12

Emend
    Administration route: Oral
    Start date: 2011-07-08
    End date: 2011-07-08

Emend
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-13

Zofran
    Start date: 2011-07-08
    End date: 2011-07-13

Valacyclovir Hydrochloride
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Amikacin
    Start date: 2011-07-11
    End date: 2011-07-12

Piperacillin and Tazobactam
    Start date: 2011-07-11
    End date: 2011-07-12

Ciprofloxacin
    Start date: 2011-07-13
    End date: 2011-07-15

Other drugs received by patient: Pentacarinat; Bactrim; Targocid; Fasturtec; Tienam; Hydrea



Possible Zofran side effects / adverse reactions in 13 year old male

Reported by a physician from United States on 2011-10-10

Patient: 13 year old male weighing 39.6 kg (87.1 pounds)

Reactions: Anxiety, Confusional State, Akathisia, Pruritus, Pain, Chills, Anger, Memory Impairment, Paraesthesia

Suspect drug(s):
Methotrexate
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Pegaspargase
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Zofran
    Indication: Product Used FOR Unknown Indication

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Bactrim
    Indication: Product Used FOR Unknown Indication

Ranitidine
    Indication: Product Used FOR Unknown Indication

Prednisone
    Dosage: 20mgm2 cyclic
    Administration route: Oral
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Benadryl
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Indication: Precursor B-Lymphoblastic Lymphoma

Hydrocortisone
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Ativan
    Indication: Product Used FOR Unknown Indication

Velcade
    Dosage: 1.3mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Doxorubicin HCL
    Dosage: 60mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Scopolamine
    Indication: Product Used FOR Unknown Indication



See index of all Zofran side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-29

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