Drug Safety Information for NORFLEX (Orphenadrine citrate)

Adverse Drug Reactions for NORFLEX* (Orphenadrine citrate)

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 NORFLEX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pain	105
2	Nausea	79
3	Headache	71
4	Anxiety	71
5	Dyspnoea	67
6	Fall	64
7	Back pain	63
8	Depression*	59
9	Arthralgia	55
10	Chest pain	50
11	Dizziness*	49
12	Vomiting	48
13	Insomnia	46
14	Pain in extremity	45
15	Diarrhoea	44
16	Asthenia	44
17	Fatigue	43
18	Hypoaesthesia	42
19	Oedema peripheral	41
20	Drug ineffective*	40

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	401
2	Muscle relaxant therapy	199
3	Muscle spasms*	140
4	Pain	134
5	Back pain*	69
6	Neck pain*	64
7	Muscle tightness	42
8	Fibromyalgia	36
9	Headache	25
10	Migraine	24

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

Types of Adverse Events for NORFLEX

Total Reports Filed with FDA: 6935

Number of FDA Adverse Event Reports by Patient Age for NORFLEX

Total Reports Filed with FDA: 6935*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Orphenadrine citrate (Orphenadrine citrate, Norflex)

Charts are based on 6935 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.