Drug Safety Information for ALTACE (Ramipril)

Safety-related Labeling Changes for ALTACE (RAMIPRIL) Rx Drug: FDA Link

Adverse Drug Reactions for ALTACE* (Ramipril)

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 ALTACE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2470
2Renal failure acute2261
3Nausea2115
4Drug interaction2105
5Diarrhoea1842
6Dizziness*1764
7Myocardial infarction1758
8Vomiting1716
9Fatigue*1595
10Asthenia1593
11Hypotension1591
12Fall1513
13Drug ineffective1301
14Anaemia1255
15Malaise1242
16Chest pain1233
17Headache*1221
18Renal failure1158
19Pain*1151
20Confusional state1125

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

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

Reason # of FDA Reports
1Hypertension*34821
2Product used for unknown indication21510
3Blood pressure*1735
4Cardiac failure*1717
5Essential hypertension1361
6Cardiac disorder1156
7Blood pressure increased*780
8Myocardial infarction*666
9Prophylaxis621
10Myocardial ischaemia471

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


Types of Adverse Events for ALTACE

Total Reports Filed with FDA: 201031


Number of FDA Adverse Event Reports by Patient Age for ALTACE

Total Reports Filed with FDA: 201031*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ramipril (Ramace, Delix, Triatec, Vesdil, Tritace, Acovil, Ramipril, Altace)

Charts are based on 201031 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 ALTACE 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.