PROPRANOLOL for Off label use: Side Effects & Safety Data
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There are 1,576 adverse event reports in the FDA FAERS database where PROPRANOLOL was used for Off label use.
Most Reported Side Effects for PROPRANOLOL
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 5,157 | 26.5% | 178 | 759 |
| Drug ineffective | 2,510 | 12.9% | 55 | 470 |
| Product use in unapproved indication | 2,210 | 11.4% | 78 | 327 |
| Product use issue | 2,068 | 10.6% | 127 | 392 |
| Toxicity to various agents | 1,598 | 8.2% | 936 | 756 |
| Completed suicide | 1,404 | 7.2% | 1,403 | 433 |
| Hypotension | 963 | 5.0% | 114 | 614 |
| Product administered to patient of inappropriate age | 960 | 4.9% | 18 | 55 |
| Bradycardia | 934 | 4.8% | 118 | 552 |
| Nausea | 904 | 4.7% | 196 | 186 |
| Drug intolerance | 894 | 4.6% | 5 | 64 |
| Headache | 894 | 4.6% | 191 | 140 |
| Drug ineffective for unapproved indication | 846 | 4.4% | 15 | 154 |
| Inappropriate schedule of product administration | 806 | 4.1% | 6 | 26 |
| Dizziness | 767 | 3.9% | 195 | 128 |
Other Indications for PROPRANOLOL
Product used for unknown indication (5,536)
Haemangioma (2,830)
Migraine (1,982)
Infantile haemangioma (1,693)
Hypertension (703)
Anxiety (300)
Tremor (261)
Suicide attempt (229)
Tachycardia (224)
Hyperthyroidism (196)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)
LACOSAMIDE (842)