Drug class · FAERS comparison
Central Nervous System Stimulant side effects compared: 12 drugs, 160,230 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Methylphenidate | 58,431 | 61% | 2,604 | boxed | Tic; Pre-existing condition improved; Decreased eye contact | Growth retardation; Somnambulism |
| Dextroamphetamine (Xelstrym) | 41,214 | 44% | 504 | boxed | Pre-existing condition improved; Terminal insomnia; Sudden onset of sleep | Sleep apnoea syndrome; Inability to afford medication |
| Methylphenidate | 28,775 | 38% | 1,105 | boxed | Application site erythema; Application site irritation; Application site urticaria | Drug administered at inappropriate site; Educational problem |
| Amphetamine | 7,975 | 84% | 3,899 | boxed | Suspected suicide; Drug use disorder; Substance use disorder | Toxicity to various agents; Cardio-respiratory arrest |
| Caffeine (Uplift Chewable) | 7,794 | 89% | 3,150 | – | – | – |
| Dextroamphetamine (Xelstrym) | 4,056 | 52% | 100 | boxed | Irritability; Psychotic disorder; Muscle twitching | Migraine; Sleep apnoea syndrome |
| Dextroamphetamine (Xelstrym) | 3,717 | 49% | 117 | boxed | Application site erythema; Suicidal ideation; Application site pain | Sleep apnoea syndrome; Sedation |
| Caffeine (Uplift Chewable) | 2,261 | 97% | 1,172 | – | – | – |
| Amphetamine | 2,175 | 77% | 964 | boxed | Aggression; Rhabdomyolysis; Agitation | Toxicity to various agents; Cardiac arrest |
| Amphetamine | 1,699 | 89% | 960 | boxed | Rhabdomyolysis; Aggression; Coma | Toxicity to various agents; Cardiac arrest |
| Methylphenidate | 1,270 | 84% | 130 | boxed | Convulsion; Irritability; Suicide attempt | Aggression; Agitation |
| Dextroamphetamine (Xelstrym) | 863 | 21% | 5 | boxed | Irritability; Anger | Inability to afford medication; Insurance issue |
Class-wide signals (flagged in at least 6 of 12 members)
No term is flagged in at least half the members.
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Adhesive tape use | Methylphenidate | 141 | 453.9 | Not in label — unassessed |
| Knee arthroplasty | Caffeine | 307 | 138.6 | No label text to screen |
| Joint dislocation | Caffeine | 140 | 125.0 | No label text to screen |
| Infusion related reaction | Caffeine | 869 | 123.6 | No label text to screen |
| Hepatic cirrhosis | Caffeine | 243 | 122.2 | No label text to screen |
| Drug administered at inappropriate site | Methylphenidate | 680 | 49.4 | Not in label — unassessed |
| Gait inability | Caffeine | 595 | 49.2 | No label text to screen |
| Night sweats | Caffeine | 571 | 48.6 | No label text to screen |
| Application site urticaria | Methylphenidate | 140 | 48.0 | Labeled (related wording) |
| Substance use disorder | Amphetamine | 53 | 44.7 | Labeled — boxed warning |
| Road traffic accident | Caffeine | 683 | 44.6 | No label text to screen |
| Osteoarthritis | Caffeine | 678 | 43.6 | No label text to screen |
| Pregnancy | Caffeine | 322 | 43.5 | No label text to screen |
| Stomatitis | Caffeine | 933 | 42.0 | No label text to screen |
| Trichotillomania | Methylphenidate | 57 | 38.0 | Not in label — unassessed |
| Application site erosion | Methylphenidate | 60 | 35.5 | Labeled (related wording) |
| Tic | Methylphenidate | 492 | 35.2 | Labeled — boxed warning |
| Suspected suicide | Amphetamine | 60 | 32.5 | Labeled (related wording) |
| Self-destructive behaviour | Methylphenidate | 61 | 31.5 | Not in label — unassessed |
| Growth retardation | Methylphenidate | 232 | 30.2 | Not in label — unassessed |
| Postural orthostatic tachycardia syndrome | Dextroamphetamine | 58 | 23.5 | Not in label — unassessed |
| Application site pain | Dextroamphetamine | 91 | 23.4 | Labeled adverse reaction |
| Obstructive sleep apnoea syndrome | Dextroamphetamine | 60 | 22.8 | Not in label — unassessed |
| Snoring | Dextroamphetamine | 158 | 22.2 | Not in label — unassessed |
| Distractibility | Methylphenidate | 67 | 21.9 | Not in label — unassessed |
Common questions
Which central nervous system stimulant has the most FDA adverse event reports?
Methylphenidate has the most FAERS co-reports in this class (58,431), followed by Dextroamphetamine (41,214). 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 central nervous system stimulant drugs?
No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.
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.