Drug Safety Information for D.H.E. 45 (Dihydroergotamine mesylate)

Safety-related Labeling Changes for D.H.E. 45 (DIHYDROERGOTAMINE MESYLATE) Rx Drug: FDA Link

Safety-related Labeling Changes for MIGRANAL (DIHYDROERGOTAMINE MESYLATE) Rx Drug: FDA Link

Adverse Drug Reactions for D.H.E. 45* (Dihydroergotamine mesylate)

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 D.H.E. 45
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Headache*33
2Nausea*30
3Chest pain29
4Migraine29
5Pain26
6Pyrexia24
7Dyspnoea23
8Dizziness*21
9Drug ineffective*21
10Fatigue19
11Arthralgia19
12Fall19
13Drug interaction17
14Vomiting*17
15Anxiety16
16Hypotension15
17Insomnia15
18Medication error15
19Oedema peripheral14
20Abdominal pain upper14

* This side effect also appears in "Top 10 Side Effects of D.H.E. 45 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking D.H.E. 45
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Migraine*514
2Product used for unknown indication193
3Headache158
4Orthostatic hypotension45
5Status migrainosus28
6Hypotension25
7Dizziness18
8Confusional state15
9Ill-defined disorder11
10Hypertension9

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


Types of Adverse Events for D.H.E. 45

Total Reports Filed with FDA: 2908


Number of FDA Adverse Event Reports by Patient Age for D.H.E. 45

Total Reports Filed with FDA: 2908*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dihydroergotamine mesylate (Dihydroergotamine, D.h.e. 45, Migranal)

Charts are based on 2908 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 D.H.E. 45 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.