(risperidone long acting injection)
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Last Updated: 07/31/2025
Please refer to the following section of the Full Prescribing Information which is relevant to your inquiry: ADVERSE REACTIONS.
| Double-Blind Trials | ||||||
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| Pandina (2011)2 | Following a ≤7-day screening, washout, and tolerability period, patients were randomized to receive 1 of 2 treatments for a 13-week, double-blind period: PALM (n=606)
RLAI (n=608)
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| Fu (2014)5 | PALM (n=161)
RLAI (n=173)
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| Quiroz (2010)6 | Open-label RLAI 25-50 mg every 2 weeks then RLAI 25-50 mg every 2 weeks (n=154) or Placebo (n=149) | One patient on RLAI in the open-label stabilization phase and one patient on placebo in the double-blind phase reported injection site pain.
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| Chue (2005)7 | RLAI 25, 50, or 75 mg every 2 weeks (n=319) or RIS oral 2, 4 or 6 mg/day (n=321) |
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| Kane (2003)8 | RLAI 25, 50, or 75 mg every 2 weeks or Placebo | Patient ratings of injection site pain | ||||
| | RLAI | |||||
| | PBO | 25 mg | 50 mg | 75 mg | ||
| Mean VAS score at 1st | 16.7 n=96 | 12.0 n=97 | 18.2 n=102 | 16.7 n=100 | ||
| Mean VAS score at 6th | 12.6 n=32 | 9.0 n=44 | 11.8 n=43 | 8.5 n=45 | ||
| Investigator ratings of injection site pain and swelling | ||||||
| | RLAI | |||||
| | PBO | 25 mg | 50 mg | 75 mg | ||
| Pain after 6thinj -% rated as absent | 90% n=31 | 80% n=45 | 81% n=43 | 84% n=45 | ||
| Swelling after 6th inj -% rated as absent | 100% n=31 | 100% n=45 | 100% n=43 | 100% n=45 | ||
| Single-Blind Trials | ||||||
| Bai (2007)9 | RLAI 25, 37.5, or 50 mg every 2 weeks based on previous RIS oral dose (n=25) (flexible dose) Or RIS oral dose maintained at the patient’s dose prior to study entry (mean=3.8 mg/day); dose could be increased (n=25) | VAS pain rating scores (patient rated; 0=no pain, 10=unbearable pain) averaged 3.4 to 4.1 over the first 12 weeks, and the mean score (±SD) was 2.9±3.0 after 48 weeks. These scores corresponded to mild pain. | ||||
| Open-Label Trials | ||||||
| Suzuki (2012)11 Stratified RLAI Groups: ≥60 years (n=18; mean age: 64.6 years) <60 years (n=13; mean age: 45.4 years) | RLAI initiated at 25 mg via gluteal injection every 2 weeks and increased after 8 weeks as needed to optimize dose.
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| Rosenheck (2011)12 | RLAI 25 mg every 2 weeks with dose titration every 4 weeks in 12.5 increments up to a maximum dose of 50 mg; oral antipsychotics were continued for at least 3 weeks and then reduced and discontinued. Or Psychiatrist's choice of an oral antipsychotic. | RLAI patients (n=85) reported more administration site conditions (injection-related pain or induration) and general disorders than the oral treatment group (n=63); P=0.03 | ||||
| Ruan (2011)13 | RLAI was initiated at 25 or 37.5 mg IM (gluteal) every 2 weeks based upon pre-study medication (4-week run in period with risperidone or olanzapine). Incremental titrations (12.5 mg) to a maximum dose of: 50 mg occurred at scheduled visits following at least 4 weeks of treatment with each dose. | Self-ratings of local injection site pain (gluteal) were low for both treatment groups and decreased over the 24-week study. Injection site responses were uncommon (redness, swelling, induration). | ||||
| Chengappa (2010)14 | RLAI 25-50 mg every 2 weeks (n=23) or Oral atypical antipsychotic (n=25) | For patients receiving RLAI:
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| Arunpongpaisal (2010)15 | RLAI 25-50 mg every 2 weeks (flexible dosing) |
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| Kulkarni (2010)16 | Patients currently on a maintenance dose of RLAI participated in survey. | The median score on the VAS (0-100) was 38.0. The types of pain described were stinging (55.3%) throbbing (17.9%), aching (17.9%), burning (12.5%) and other (14.2%). The mean duration of pain was about 1 hour. | ||||
| Gharabawi (2007)17 | RLAI 50 mg every 2 weeks for 4 weeks then RLAI 50 mg once monthly for 48 weeks | The incidence of injection site pain was 2.3%. | ||||
| Lindenmayer (2007)18 | Trial A: RLAI 25, 50, or 75 mg every 2 weeks Trial B: RLAI 25, 37.5, or 50 mg every 2 weeks median modal dose of 50 mg/ 2 weeks for both trials (flexible dose) (n=271) | Trial A: Eight patients (3%) reported an adverse event at the injection site. Four patients experienced mild pain, and 1 patient each experienced mild bleeding, bruising, inflammation, and reaction. Trial B: One patient (1%) reported mild pain, and there were no reports of discontinuation due to an injection site adverse event. | ||||
| Taylor (2009)20 | RLAI 25, 37.5, 50, or 75 mg every 2 weeks |
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| Kissling (2005)22 | RLAI 25 mg, 37.5 mg, or 50 mg every 2 weeks | Nine patients (1%) reported adverse events associated with the injection site; 8 were reported as injection pain. | ||||
| Moller (2005)23 | RLAI 25, 37.5, or 50 mg every 2 weeks | One percent of patients (n=27) reported adverse events associated with the injection site, of which 24 were reported as injection pain. | ||||
| Lindenmayer (2004)19 conducted a 12-week, open-label trial in patients with schizophrenia switched from oral treatment with haloperidol, quetiapine, or olanzapine (n=141) | RLAI 25, 37.5, or 50 mg every 2 weeks | Mild pain at the injection site was reported by one patient in the prior quetiapine group following the first injection of risperidone long-acting. No other injection site reactions were reported. | ||||
| Fleischhacker (2003)24 | RLAI 25, 50, or 75 mg every 2 weeks | Patient ratings of injection site pain Median VAS score at 1st injection: 10 Median VAS score at 25th injection: 5 Investigator ratings Investigators rated injection site pain as absent in 68% of patients at the first injection and absent in 80% of patients at the last injection. Investigators rated redness as absent in 95% and 100% of patients, swelling as absent in 98% and 100%, and induration as absent in 100% and 93% at the first and last injections, respectively. | ||||
| Retrospective Chart Review | ||||||
| Deslandes (2007)25 | RLAI (mean dose=39.2 mg) every 2 weeks | Of the 31 patients who discontinued treatment, 3 discontinued due to pain. | ||||
| Abbreviations: INJ, injection; PALM, paliperidone palmitate; PBO, placebo; RLAI, risperidone long-acting injection; RIS, risperidone; SD, standard deviation; VAS, visual analog scale.a | ||||||
Heres (2012)26
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| Baseline: Thirty-four (57%) patients chose to switch to deltoid injections.
Three-Month Follow-Up: Twenty-five of the thirty-four “switchers” participated in the follow-up assessment.
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| Quiroz (2011)27 Single-dose study: Randomized, multicenter, two-way crossover study (n=170) measuring safety and pharmacokinetic properties by comparing single-dose DM (deltoid muscle) and GM (gluteal muscle) injections of RLAI in patients with chronic stable schizophrenia. Multi-dose study: Multi-dose, multicenter, safety study (n=53) evaluating DM injection of RLAI in patients with schizophrenia | Single-dose study: RLAI 25 or 50 mg GM, 37.5 or 50 mg DM | Investigator-rated: Single-dose study:
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| Multi-dose study: RLAI 37.5 or 50 mg DM every 2 weeks for 4 doses (flexible dosing) | Multi-dose study:
Patient-rated: Single-dose study: Mean change from baseline VAS scores (mm) 2 hours post injection: 25 mg GM: 1.1 50 mg GM: 0.5 37.5 mg DM: 3.4 50 mg DM: 1.1
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| Abbreviations: DM, deltoid muscle; GM, gluteal muscle; RLAI, risperidone long-acting injection.aVAS=visual analogue scale (patient rated; 0=no pain, 100=unbearably painful).bInvestigators rated the injection site for redness, pain, swelling and induration using a four-point scale (absent, mild, moderate, severe). | ||
Saxena et al (2008)28
Lindenmayer et al (2005)29
The reference section lists published letters to the editor that describe clinical experience with RISPERDAL CONSTA and injection site pain.30
A literature search of MEDLINE®
| 1 | RISPERDAL CONSTA (risperidone long-acting injection) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-63671f9d-1035-4290-a18b-1c9102cceb15 |
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