Ritalin LA

Ritalin LA Adverse Reactions





Full Prescribing Info
Adverse Reactions
Nervousness and insomnia are very common adverse reactions which occur at the beginning of Ritalin treatment but can usually be controlled by reducing the dosage and/or omitting the afternoon or evening dose.
Decreased appetite is also very common but usually transient. Abdominal pain, nausea and vomiting are common to very common, usually occur at the beginning of treatment and may be alleviated by concomitant food intake.
Tabulated summary of adverse drug reactions: Adverse drug reactions (Table 5) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 5.)

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Very rare reports of poorly documented neuroleptic malignant syndrome (NMS) have been received. In most of these reports, patients were also receiving other medications. It is uncertain what role Ritalin played in these cases.
Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been derived from post-marketing experience with Ritalin via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency, which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 6.)

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Additional adverse reactions reported with other methylphenidate-containing products: The list as follows shows adverse reactions not listed for Ritalin (see Table 5) that have been reported with other methylphenidate-containing products based on clinical studies data and post-marketing spontaneous reports.
Blood and lymphatic disorders: Pancytopenia.
Immune system disorders: Hypersensitivity reactions such as auricular swelling.
Psychiatric disorders: Irritability, affect lability, abnormal behavior or thinking, anger, mood altered, mood swings, hypervigilance, mania, disorientation, libido disorder, apathy, repetitive behaviors, over-focusing, confusional state, dependence. Cases of abuse and dependence have been described, more often with immediate-release formulations.
Nervous system disorders: Reversible ischemic neurological deficit, migraine.
Eye disorders: Diplopia, mydriasis, visual disturbance.
Cardiac disorders: Cardiac arrest, myocardial infarction.
Respiratory, thoracic and mediastinal disorders: Pharyngolaryngeal pain, dyspnea.
Gastrointestinal disorders: Diarrhea, constipation.
Skin and subcutaneous tissue disorders: Angioneurotic edema, erythema, fixed drug eruption.
Musculoskeletal, connective tissue and bone disorders: Myalgia, muscle twitching.
Renal and urinary disorders: Hematuria.
Reproductive system and breast disorders: Gynecomastia.
General disorders and administration site conditions: Chest pain, fatigue, sudden cardiac death.
Investigations: Cardiac murmur.
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