alpha-Adrenergic Agonist side effects compared: 6 drugs, 115,002 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Epinephrine | 65,037 | 57% | 4,076 | – | Infusion site pain; Infusion site erythema; Infusion site extravasation | Liquid product physical issue; Stress cardiomyopathy |
| Adrenalinum (Epinephrine) | 41,221 | 63% | 3,503 | – | – | – |
| Adrenalinum (Epinephrine) | 3,902 | 59% | 157 | – | – | – |
| Adrenalinum (Epinephrine) | 3,902 | 59% | 157 | – | – | – |
| Epinephrine Inhalation (Primatene Mist) | 479 | 56% | 21 | – | – | Throat irritation; Burning sensation |
| Epinephrine | 461 | 89% | 38 | – | Palpitations; Impaired work ability; Chronic obstructive pulmonary disease | Loss of personal independence in daily activities; Arthritis |
Class-wide signals (flagged in at least 3 of 6 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Infusion site pain | 4/6 | 14.7 | 1,689 | 1/4 members' labels |
| Frequent bowel movements | 3/6 | 9.4 | 166 | 0/3 members' labels |
| Impaired quality of life | 3/6 | 6.7 | 92 | 0/3 members' labels |
| Poor venous access | 3/6 | 6.2 | 36 | 0/3 members' labels |
| Impaired work ability | 3/6 | 4.8 | 106 | 1/3 members' labels |
| Colitis ulcerative | 3/6 | 4.7 | 153 | 0/3 members' labels |
| Burning sensation | 3/6 | 4.4 | 144 | 0/3 members' labels |
| Fibromyalgia | 3/6 | 4.4 | 52 | 0/3 members' labels |
| Haematochezia | 3/6 | 4.0 | 154 | 0/3 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| No device malfunction | Epinephrine | 60 | 19,013.4 | Not in label — unassessed |
| Injection site pallor | Epinephrine | 127 | 212.9 | Labeled adverse reaction |
| Tubulointerstitial nephritis | Epinephrine | 71 | 173.1 | Not in label — unassessed |
| Loss of personal independence in daily activities | Epinephrine | 122 | 117.0 | Not in label — unassessed |
| Swollen tongue | Epinephrine | 71 | 103.5 | Not in label — unassessed |
| Systemic lupus erythematosus | Epinephrine | 73 | 94.1 | Not in label — unassessed |
| Nightmare | Epinephrine | 71 | 93.1 | Not in label — unassessed |
| Rectal haemorrhage | Epinephrine | 71 | 75.0 | Not in label — unassessed |
| Administration site swelling | Epinephrine | 61 | 74.6 | Labeled (related wording) |
| Tinnitus | Epinephrine | 70 | 69.3 | Not in label — unassessed |
| Eczema | Epinephrine | 72 | 65.2 | Not in label — unassessed |
| Vertigo | Epinephrine | 72 | 53.8 | Not in label — unassessed |
| Deep vein thrombosis | Epinephrine | 73 | 50.9 | Not in label — unassessed |
| Arthritis | Epinephrine | 84 | 48.5 | Not in label — unassessed |
| Stress | Epinephrine | 74 | 46.8 | Not in label — unassessed |
| Dysgeusia | Epinephrine | 70 | 42.7 | Not in label — unassessed |
| Injection site laceration | Epinephrine | 67 | 37.6 | Labeled (related wording) |
| Migraine | Epinephrine | 74 | 35.5 | Not in label — unassessed |
| Pulmonary embolism | Epinephrine | 73 | 34.8 | Not in label — unassessed |
| Infusion site nodule | Epinephrine | 86 | 33.9 | Labeled (related wording) |
| Insurance issue | Adrenalinum | 926 | 33.7 | No label text to screen |
| Vasoplegia syndrome | Adrenalinum | 97 | 32.4 | No label text to screen |
| Asthma | Epinephrine | 75 | 30.5 | Not in label — unassessed |
| Palpitations | Epinephrine | 75 | 29.2 | Labeled adverse reaction |
| Administration site pain | Epinephrine | 86 | 26.4 | Labeled (related wording) |
Common questions
Which alpha-adrenergic agonist has the most FDA adverse event reports?
Epinephrine has the most FAERS co-reports in this class (65,037), followed by Adrenalinum (41,221). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across alpha-adrenergic agonist drugs?
Reaction terms flagged in at least half of the 6 members include infusion site pain, frequent bowel movements, impaired quality of life, poor venous access, impaired work ability. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.