Drug Safety Information for ALOXI (Palonosetron hydrochloride)

Safety-related Labeling Changes for ALOXI (PALONOSETRON HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ALOXI* (Palonosetron hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ALOXI
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death854
2Nausea618
3Fatigue492
4Off label use467
5Vomiting435
6Dyspnoea381
7Diarrhoea348
8Decreased appetite263
9Pain251
10Constipation250
11Asthenia236
12Abdominal pain231
13Pyrexia231
14Dehydration218
15Disease progression212
16Anaemia210
17Neutropenia193
18Back pain182
19Rash178
20Headache173

* This side effect also appears in "Top 10 Side Effects of ALOXI " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ALOXI
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Prophylaxis of nausea and vomiting1817
2Product used for unknown indication1415
3Premedication1190
4Nausea656
5Prophylaxis353
6Antiemetic supportive care277
7Breast cancer94
8Vomiting85
9Prophylactic chemotherapy49
10Prostate cancer35

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ALOXI

Total Reports Filed with FDA: 24520


Number of FDA Adverse Event Reports by Patient Age for ALOXI

Total Reports Filed with FDA: 24520*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Palonosetron hydrochloride (Palonosetron, Aloxi)

Charts are based on 24520 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ALOXI Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on ALOXI's side effects.