What the label lists and what reports show

Risperidone side effects

Risperidone's FDA label: “The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea …” FAERS holds 131,095 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is gynaecomastia (24,647 reports).

Generic listed
Boxed warning

Check it at the source: the risperidone FDA label on DailyMed (effective May 28, 2026, Janssen Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

Table 8. Adverse Reactions in ≥2% of RISPERDAL-Treated Adult Patients (and greater than placebo) with Schizophrenia in Double-Blind, Placebo-Controlled Trials

System/Organ Class Adverse Reaction	2–8 mg per day (N=366)	>8–16 mg per day (N=198)	Placebo (N=225)
Tachycardia	1	3	0
Vision blurred	3	1	1
Nausea	9	4	4
Constipation	8	9	6
Dyspepsia	8	6	5
Dry mouth	4	0	1
Abdominal discomfort	3	1	1
Salivary hypersecretion	2	1	<1
Diarrhea	2	1	1
Fatigue	3	1	0
Chest pain	2	2	1
Asthenia	2	1	<1
Nasopharyngitis	3	4	3
Upper respiratory tract infection	2	3	1
Sinusitis	1	2	1
Urinary tract infection	1	3	0
Blood creatine phosphokinase increased	1	2	<1
Heart rate increased	<1	2	0
Back pain	4	1	1
Arthralgia	2	3	<1
Pain in extremity	2	1	1
Parkinsonism Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness,…	14	17	8
Akathisia	10	10	3
Sedation	10	5	2
Dizziness	7	4	2

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued
The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Tardive dyskinesia [see Warnings and Precautions (5.4) ] Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions (5.5) ] Hyperprolactinemia [see Warnings and Precautions (5.6) ] Orthostatic hypotension [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.9) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Dysphagia [see Warnings and Precautions (5.12) ] Priapism [see Warnings and Precautions (5.13) ] Disruption of body temperature regulation [see Warnings and Precautions (5.14) ] Patients with Phenylketonuria [see Warnings and Precautions (5.15) ].

Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective May 28, 2026 (SPL set 7e117c7e-02fc-4343-92a1-230061dfc5e0), via openFDA; the full label on DailyMed

What do FAERS reports show?

131,095 reports list risperidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10,143 are coded as a death and 40,056 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Gynaecomastia (named in the label)24,647
Off Label Use (a use or a product term, not a reaction)12,414
Abnormal Weight Gain9,451
Weight Increased (named in the label)9,189
Drug Ineffective (a use or a product term, not a reaction)7,629
Product Use In Unapproved Indication (a use or a product term, not a reaction)5,965
Emotional Disorder5,956
Injury (named in the label)4,631
Drug Interaction (a use or a product term, not a reaction)4,550
Hyperprolactinaemia (named in the label)4,474
Somnolence (named in the label)4,401
Galactorrhoea (named in the label)3,758
Obesity (named in the label)3,717
Emotional Distress3,529
Extrapyramidal Disorder (named in the label)3,457
Anxiety (named in the label)3,233
Condition Aggravated (a use or a product term, not a reaction)3,116
Suicide Attempt3,082
Fatigue (named in the label)3,021
Diabetes Mellitus (named in the label)2,831
Fall2,824
Insomnia (named in the label)2,773
Product Use Issue (a use or a product term, not a reaction)2,771
Aggression (a use or a product term, not a reaction)2,763
Treatment Noncompliance2,751

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Risperidone: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions