Drug Safety Information for LUDIOMIL (Maprotiline hydrochloride)

Adverse Drug Reactions for LUDIOMIL* (Maprotiline 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 LUDIOMIL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug interaction	52
2	Fall	43
3	Pyrexia	38
4	Depression*	36
5	Somnolence	29
6	Blood creatine phosphokinase increased	27
7	Overdose	25
8	Toxicity to various agents	25
9	Anxiety	25
10	Aspartate aminotransferase increased	25
11	Suicide attempt	25
12	Neuroleptic malignant syndrome	24
13	Malaise	24
14	Alanine aminotransferase increased	24
15	Asthenia	23
16	Depressed level of consciousness	22
17	Nausea	22
18	Tremor	22
19	Pneumonia	22
20	Drug ineffective	22

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

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

	Reason	# of FDA Reports
1	Depression*	1274
2	Product used for unknown indication	216
3	Major depression	92
4	Bipolar disorder	64
5	Suicide attempt	46
6	Insomnia	29
7	Nerve injury	22
8	Schizophrenia	16
9	Depressive symptom	15
10	Bipolar i disorder	12

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

Types of Adverse Events for LUDIOMIL

Total Reports Filed with FDA: 3528

Number of FDA Adverse Event Reports by Patient Age for LUDIOMIL

Total Reports Filed with FDA: 3528*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Maprotiline hydrochloride (Novo-maprotiline, Maprotiline, Ludiomil)

Charts are based on 3528 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.