Drug Safety Information for NORTHERA (Droxidopa)

Safety-related Labeling Changes for NORTHERA (DROXIDOPA) Rx Drug: FDA Link

Required post-approval safety study:

A clinical trial of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy. The trial design consists of a 3-month, open-label droxidopa treatment period, followed by a 3-month, randomized, double-blind, placebocontrolled, withdrawal period. The primary endpoint will be time to treatment intervention. Due Date: 2021-08-31

Original FDA Drug Approval Date for NORTHERA: 2014-02-18

Adverse Drug Reactions for NORTHERA* (Droxidopa)

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 NORTHERA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Blood pressure increased	127
2	Dizziness	123
3	Drug ineffective	106
4	Headache	84
5	Nausea	63
6	Fatigue	60
7	Fall	54
8	Hypertension	47
9	Blood pressure decreased	47
10	Hypotension	40
11	Malaise	39
12	Blood pressure fluctuation	38
13	Loss of consciousness	35
14	Confusional state	35
15	Feeling abnormal	34
16	Asthenia	33
17	Death	33
18	Drug dose omission	30
19	Tremor	26
20	Syncope	25

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

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

	Reason	# of FDA Reports
1	Orthostatic hypotension	820
2	Product used for unknown indication	428
3	Parkinson's disease	309
4	Dizziness	176
5	Autonomic neuropathy	154
6	Autonomic failure syndrome	68
7	Hypotension	42
8	Autonomic nervous system imbalance	38
9	Syncope	35
10	Multiple system atrophy	32

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

Types of Adverse Events for NORTHERA

Total Reports Filed with FDA: 2537

Number of FDA Adverse Event Reports by Patient Age for NORTHERA

Total Reports Filed with FDA: 2537*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Droxidopa (Northera)

Charts are based on 2537 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.

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.