Non-Standardized Chemical Allergen side effects compared: 4 drugs, 11,017 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Glycerin | 5,454 | 71% | 598 | – | – | – |
| Glycerin Suppositories (Glycerin) | 2,639 | 93% | 374 | – | – | – |
| Glycerin Suppository (Rite-Aid Glycerin Laxative) | 2,600 | 93% | 368 | – | – | – |
| Glycerine (Lemon Glycerine Swabsticks) | 324 | 95% | 44 | – | – | – |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Macular degeneration | 4/4 | 423.1 | 1,921 | 0/4 members' labels |
| Vaginal discharge | 3/4 | 123.7 | 462 | 0/3 members' labels |
| Paraesthesia oral | 3/4 | 119.0 | 642 | 0/3 members' labels |
| Oral candidiasis | 3/4 | 97.1 | 472 | 0/3 members' labels |
| Orthostatic hypotension | 3/4 | 75.8 | 499 | 0/3 members' labels |
| Procedural pain | 3/4 | 56.4 | 588 | 0/3 members' labels |
| Sedation | 3/4 | 47.5 | 469 | 0/3 members' labels |
| Frequent bowel movements | 3/4 | 47.2 | 480 | 0/3 members' labels |
| Colitis | 3/4 | 35.8 | 520 | 0/3 members' labels |
| Depressed level of consciousness | 3/4 | 35.4 | 532 | 0/3 members' labels |
| Rectal haemorrhage | 3/4 | 29.8 | 489 | 0/3 members' labels |
| Colitis ulcerative | 3/4 | 28.4 | 477 | 0/3 members' labels |
| Cognitive disorder | 3/4 | 28.3 | 504 | 0/3 members' labels |
| Infusion related reaction | 3/4 | 25.8 | 650 | 0/3 members' labels |
| Haematochezia | 3/4 | 24.3 | 511 | 0/3 members' labels |
| Mobility decreased | 3/4 | 18.9 | 519 | 0/3 members' labels |
| Bladder disorder | 3/4 | 16.8 | 63 | 0/3 members' labels |
| Dyspepsia | 3/4 | 16.8 | 633 | 0/3 members' labels |
| Constipation | 3/4 | 16.3 | 1,393 | 0/3 members' labels |
| Balance disorder | 3/4 | 15.8 | 538 | 0/3 members' labels |
| Pneumonia aspiration | 3/4 | 12.1 | 124 | 0/3 members' labels |
| Ileus | 2/4 | 9.8 | 30 | 0/2 members' labels |
| Anaemia | 2/4 | 9.7 | 462 | 0/2 members' labels |
| Metastases to central nervous system | 2/4 | 9.7 | 31 | 0/2 members' labels |
| Skin reaction | 2/4 | 9.7 | 34 | 0/2 members' labels |
| Disseminated intravascular coagulation | 2/4 | 9.1 | 32 | 0/2 members' labels |
| Urosepsis | 2/4 | 8.7 | 20 | 0/2 members' labels |
| Abdominal pain | 2/4 | 8.5 | 492 | 0/2 members' labels |
| Dementia | 2/4 | 8.2 | 57 | 0/2 members' labels |
| Toxicity to various agents | 2/4 | 8.2 | 342 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Eye pain | Glycerin | 397 | 27.8 | No label text to screen |
| Ocular discomfort | Glycerin | 68 | 24.2 | No label text to screen |
| Eye irritation | Glycerin | 285 | 19.7 | No label text to screen |
| Photophobia | Glycerin | 85 | 17.6 | No label text to screen |
| Lacrimation increased | Glycerin | 97 | 12.5 | No label text to screen |
| Ocular hyperaemia | Glycerin | 137 | 11.3 | No label text to screen |
| Dry eye | Glycerin | 132 | 10.5 | No label text to screen |
| Eye swelling | Glycerin | 77 | 8.0 | No label text to screen |
Common questions
Which non-standardized chemical allergen has the most FDA adverse event reports?
Glycerin has the most FAERS co-reports in this class (5,454), followed by Glycerin Suppositories (2,639). 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 non-standardized chemical allergen drugs?
Reaction terms flagged in at least half of the 4 members include macular degeneration, vaginal discharge, paraesthesia oral, oral candidiasis, orthostatic hypotension. 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.