Drug Safety Information for ALDOMET (Methyldopate hydrochloride)

Adverse Drug Reactions for ALDOMET* (Methyldopate 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 ALDOMET
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Premature baby213
2Caesarean section199
3Hypertension168
4Nausea111
5Maternal drugs affecting foetus96
6Dyspnoea95
7Blood pressure increased89
8Vomiting88
9Headache86
10Foetal growth restriction84
11Diarrhoea83
12Drug ineffective77
13Pre-eclampsia77
14Oedema peripheral69
15Dizziness*67
16Pain64
17Hypotension64
18Fatigue*62
19Pregnancy62
20Neonatal respiratory distress syndrome60

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

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

Reason # of FDA Reports
1Hypertension*3330
2Product used for unknown indication577
3Gestational hypertension148
4Blood pressure145
5Essential hypertension125
6Blood pressure abnormal95
7Pre-eclampsia59
8Suicide attempt48
9Foetal exposure during pregnancy48
10Maternal exposure during pregnancy46

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


Types of Adverse Events for ALDOMET

Total Reports Filed with FDA: 12159


Number of FDA Adverse Event Reports by Patient Age for ALDOMET

Total Reports Filed with FDA: 12159*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methyldopate hydrochloride (Dopegyt, Metildopa, Hydopa, Aldomet, Methyldopa)

Charts are based on 12159 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 ALDOMET 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.