Drug Safety Information for PROPRANOLOL Hydrochloride (Propranolol hydrochloride)

Safety-related Labeling Changes for INDERAL LA (PROPRANOLOL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for PROPRANOLOL Hydrochloride* (Propranolol 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 PROPRANOLOL Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea1219
2Headache991
3Drug ineffective964
4Dyspnoea*963
5Fatigue*930
6Dizziness*918
7Diarrhoea858
8Vomiting797
9Pain787
10Asthenia767
11Anxiety735
12Fall731
13Hypotension683
14Depression*648
15Malaise642
16Drug interaction624
17Insomnia*609
18Confusional state582
19Tremor574
20Toxicity to various agents561

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

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

Reason # of FDA Reports
1Product used for unknown indication10680
2Hypertension*8011
3Migraine*3025
4Tremor*1429
5Anxiety*1319
6Blood pressure969
7Cardiac disorder815
8Palpitations711
9Tachycardia*688
10Haemangioma648

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


Types of Adverse Events for PROPRANOLOL Hydrochloride

Total Reports Filed with FDA: 103842


Number of FDA Adverse Event Reports by Patient Age for PROPRANOLOL Hydrochloride

Total Reports Filed with FDA: 103842*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Propranolol hydrochloride (Anaprilin, Innopran, Propranolol, Inderal xl, Hemangeol, Propranolol hcl, Obsidan, Avlocardyl, Dociton, Inderal, Innopran xl, Inderal la)

Charts are based on 103842 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.

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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.