Drug Safety Information for LONITEN (Minoxidil)

Adverse Drug Reactions for LONITEN* (Minoxidil)

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 LONITEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness180
2Dyspnoea167
3Alopecia147
4Headache*135
5Nausea131
6Hypertension129
7Drug ineffective129
8Oedema peripheral118
9Pruritus*116
10Pain106
11Chest pain101
12Vomiting96
13Blood pressure increased93
14Fatigue88
15Anxiety*87
16Asthenia87
17Heart rate increased82
18Diarrhoea81
19Hypotension80
20Rash71

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

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

Reason # of FDA Reports
1Alopecia*3011
2Product used for unknown indication1459
3Hypertension*1003
4Androgenetic alopecia*223
5Hair growth abnormal206
6Hypotrichosis132
7Blood pressure72
8Blood pressure increased50
9Blood pressure management46
10Intentional drug misuse32

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


Types of Adverse Events for LONITEN

Total Reports Filed with FDA: 13186


Number of FDA Adverse Event Reports by Patient Age for LONITEN

Total Reports Filed with FDA: 13186*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Minoxidil (Minodyl, Minoxidil (for men), Men's rogaine, Theroxidil, Hair regrowth, Mens kirkland, Up and up minoxidil, Renewal for men, Women's rogaine, Hair regrow, Minoxidil form men, Rogaine, Cerafill retaliate, Loniten, Minoxidil for women, Minoxidil foam, Mens rogaine, Rogaine (for men), Rogaine (for women), Womens rogaine, Minoxidil)

Charts are based on 13186 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 LONITEN 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.