Drug Safety Information for MAXALT (Rizatriptan benzoate)

Safety-related Labeling Changes for MAXALT (RIZATRIPTAN BENZOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for MAXALT-MLT (RIZATRIPTAN BENZOATE) Rx Drug: FDA Link

Adverse Drug Reactions for MAXALT* (Rizatriptan benzoate)

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 MAXALT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Migraine342
2Nausea*324
3Drug ineffective317
4Headache*316
5Pain*286
6Vomiting227
7Fatigue*196
8Dizziness*181
9Anxiety175
10Dyspnoea156
11Diarrhoea150
12Depression145
13Chest pain132
14Pulmonary embolism132
15Abdominal pain123
16Arthralgia119
17Injury117
18Malaise116
19Pain in extremity110
20Asthenia108

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

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

Reason # of FDA Reports
1Migraine*5836
2Product used for unknown indication1243
3Headache*980
4Migraine without aura*21
5Migraine with aura*21
6Foetal exposure during pregnancy19
7Migraine prophylaxis19
8Premedication18
9Cluster headache*13
10Menstrual cycle management12

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


Types of Adverse Events for MAXALT

Total Reports Filed with FDA: 18333


Number of FDA Adverse Event Reports by Patient Age for MAXALT

Total Reports Filed with FDA: 18333*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rizatriptan benzoate (Not yet defined, Rizatriptan, Rizatriptan benzoate, Maxalt-mlt, Maxalt)

Charts are based on 18333 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 MAXALT Reviews and Review Summary .

Historical 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.