Drug Safety Information for NITROGLYCERIN (Nitroglycerin)

Safety-related Labeling Changes for NITROLINGUAL PUMPSPRAY (NITROGLYCERIN) Discontinued Drug: FDA Link

Safety-related Labeling Changes for NITROGLYCERIN IN DEXTROSE 5% (NITROGLYCERIN) Rx Drug: FDA Link

Safety-related Labeling Changes for NITROSTAT (NITROGLYCERIN) Rx Drug: FDA Link

Safety-related Labeling Changes for NITROMIST (NITROGLYCERIN) Rx Drug: FDA Link

Adverse Drug Reactions for NITROGLYCERIN* (Nitroglycerin)

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 NITROGLYCERIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction1944
2Chest pain1904
3Dyspnoea1898
4Pain1839
5Anxiety1501
6Nausea*1446
7Renal failure1441
8Injury1269
9Dizziness*1264
10Asthenia1128
11Cardiac failure congestive1113
12Hypotension1026
13Fatigue1002
14Death990
15Vomiting958
16Fall951
17Drug ineffective941
18Diarrhoea932
19Renal failure acute922
20Coronary artery disease922

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

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

Reason # of FDA Reports
1Product used for unknown indication11334
2Chest pain9765
3Angina pectoris4823
4Cardiac disorder1770
5Hypertension735
6Coronary artery disease531
7Myocardial ischaemia463
8Pain379
9Ill-defined disorder343
10Prophylaxis311

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


Types of Adverse Events for NITROGLYCERIN

Total Reports Filed with FDA: 148749


Number of FDA Adverse Event Reports by Patient Age for NITROGLYCERIN

Total Reports Filed with FDA: 148749*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nitroglycerin (Deponit, Nitro-bid, Nitrotab, Suscard, Nitrangin, Glonoinum kit refill, Glonoinum, Nitronal, Nitrek, Sustac, Transderm-nitro, Coro-nitro, Perlinganit, Trinitrin, Rectiv, Nitro iv, Nitrocard, Nitrodisc, Nitrol, Glytrin, Gtn, Nitro-time, Nitrocine, Nitroglyn, Nitroderm, Nitroquick, Anginine, Nitro-dur, Nitrong, Tridil, Nitrogard, Nitromist, Nitroglycerin, Nitrospan, Minitran, Nitrostat, Nitrolingual)

Charts are based on 148749 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 NITROGLYCERIN Reviews and Review Summary .

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.

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