Drug Safety Information for ANTIVERT (Meclizine hydrochloride)

Safety-related Labeling Changes for ANTIVERT (MECLIZINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ANTIVERT* (Meclizine 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 ANTIVERT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness*861
2Nausea630
3Pain488
4Fatigue*462
5Asthenia452
6Dyspnoea441
7Fall433
8Headache*426
9Drug ineffective*391
10Diarrhoea356
11Vomiting347
12Anxiety346
13Chest pain338
14Depression305
15Vertigo*293
16Cerebrovascular accident291
17Hypertension288
18Back pain276
19Arthralgia274
20Pain in extremity262

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

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

Reason # of FDA Reports
1Product used for unknown indication3737
2Dizziness*3139
3Vertigo*3081
4Nausea479
5Meniere's disease262
6Motion sickness*232
7Inner ear disorder118
8Balance disorder105
9Suicide attempt72
10Multiple sclerosis42

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


Types of Adverse Events for ANTIVERT

Total Reports Filed with FDA: 46392


Number of FDA Adverse Event Reports by Patient Age for ANTIVERT

Total Reports Filed with FDA: 46392*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Meclizine hydrochloride (Meclizine hcl, Motion-time, Sea-calm, Verticalm, Motion sickness ii, Naus-ease, Zentrip, Meclozine, Meclizine, Agyrax, Bonamine, Travel-ease, Antivert)

Charts are based on 46392 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 ANTIVERT 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.