Common Concerta Side Effects


The most commonly reported Concerta side effects (click to view or check a box to report):

Aggression (151)
Headache (146)
Suicidal Ideation (145)
Depression (130)
Insomnia (126)
Suicide Attempt (124)
Growth Retardation (119)
Weight Decreased (108)
Tachycardia (106)
Decreased Appetite (102)
Hallucination (94)
Overdose (92)
Chest Pain (91)
Abnormal Behaviour (89)
Psychotic Disorder (85)
Agitation (84)
Anxiety (82)
Nausea (78)
Dizziness (76)
Vomiting (76)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Concerta Side Effects Reported to FDA



Concerta Side Effect Report#9461684
Ear Infection
This is a report of a 9-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: NA, start time:
Aug 07, 2013), combined with: NA. and developed a serious reaction and side effect(s): Ear Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Ear Infection side effect.
Concerta Side Effect Report#9459986
Fear, Abnormal Behaviour
This report suggests a potential Concerta Fear side effect(s) that can have serious consequences. A 13-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: 1 Pill Once In Morning By Mouth) starting 201109. After starting Concerta the patient began experiencing various side effects, including: Fear, Abnormal BehaviourAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fear, may still occur.
Concerta Side Effect Report#9452492
Performance Status Decreased, Educational Problem, Disturbance In Attention, Impulse-control Disorder, Daydreaming, Abnormal Behaviour
This Performance Status Decreased problem was reported by a consumer or non-health professional from US. A 10-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
May 01, 2013 this consumer started treatment with Concerta 36mg (dosage: 2 Pills, Once Daily, Taken By Mouth). The following drugs were being taken at the same time: NA. When using Concerta 36mg, the patient experienced the following unwanted symptoms/side effects: Performance Status Decreased, Educational Problem, Disturbance In Attention, Impulse-control Disorder, Daydreaming, Abnormal BehaviourAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Performance Status Decreased, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9445544
Weight Increased, Hypertension, Heart Rate Increased
This Weight Increased side effect was reported by a pharmacist from DE. A 15-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Concerta (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Weight Increased, Hypertension, Heart Rate IncreasedThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9444689
Product Substitution Issue, Product Formulation Issue, Product Quality Issue
This is a report of a 25-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: 90 Day Refill, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue, Product Formulation Issue, Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Product Substitution Issue side effect.
Concerta Side Effect Report#9444336
Cardiac Disorder
This report suggests a potential Concerta Cardiac Disorder side effect(s) that can have serious consequences. A 17-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting NS. After starting Concerta the patient began experiencing various side effects, including: Cardiac DisorderAdditional drugs used concurrently:
  • Dexamfetamine
  • Ritalin
  • Ritalin La
  • Clonidine
  • Melatonin
Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Disorder, may still occur.
Concerta Side Effect Report#9444334
Scoliosis
This Scoliosis problem was reported by a pharmacist from JP. A 11-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On 201304 this consumer started treatment with Concerta (dosage: NA). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: ScoliosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Scoliosis, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9442921
Cardiomyopathy, Ventricular Extrasystoles
This Cardiomyopathy side effect was reported by a health professional from FR. A 37-year-old male patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta (drug dosage: NA), which was initiated on 2006. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Cardiomyopathy, Ventricular ExtrasystolesThese side effects may potentially be related to Concerta. The patient was hospitalized.
Concerta Side Effect Report#9442920
Tic
This is a report of a 9-year-old male patient (weight: NA) from CY, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder,aggression, who was treated with Concerta (dosage: NA, start time: 201209), combined with:
  • Risperdal
and developed a serious reaction and side effect(s): Tic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Tic side effect.
Concerta Side Effect Report#9439850
Acute Myocardial Infarction, Intracardiac Thrombus, Ventricular Hypokinesia, Implantable Defibrillator Insertion, Coronary Artery Stenosis, Ventricular Fibrillation, Ejection Fraction Decreased
This report suggests a potential Concerta Acute Myocardial Infarction side effect(s) that can have serious consequences. A 11-year-old male patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting NS. After starting Concerta the patient began experiencing various side effects, including: Acute Myocardial Infarction, Intracardiac Thrombus, Ventricular Hypokinesia, Implantable Defibrillator Insertion, Coronary Artery Stenosis, Ventricular Fibrillation, Ejection Fraction DecreasedAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Myocardial Infarction, may still occur.
Concerta Side Effect Report#9436880
Tachycardia
This Tachycardia problem was reported by a physician from ZA. A 19-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: disturbance in attention. On NS this consumer started treatment with Concerta (dosage: NA). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: TachycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tachycardia, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9435846
Headache, Anger, Aggression, Social Avoidant Behaviour, Fatigue, Feeling Abnormal, Product Substitution Issue
This Headache side effect was reported by a consumer or non-health professional from US. A 10-year-old male patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta (drug dosage: NA), which was initiated on
May 10, 2013. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Headache, Anger, Aggression, Social Avoidant Behaviour, Fatigue, Feeling Abnormal, Product Substitution IssueThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9434395
Suicide Attempt, Intentional Overdose, Off Label Use
This is a report of a 18-year-old male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: social phobia, who was treated with Concerta (dosage: NA, start time: NS), combined with:
  • Sertraline
and developed a serious reaction and side effect(s): Suicide Attempt, Intentional Overdose, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Concerta Side Effect Report#9432449
Hyperventilation, Chest Discomfort, Dizziness, Formication
This report suggests a potential Concerta Hyperventilation side effect(s) that can have serious consequences. A 23-year-old male patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: NA and used Concerta (dosage: 1/8 Of The 54 Mg Tablet) starting
May 19, 2013. After starting Concerta the patient began experiencing various side effects, including: Hyperventilation, Chest Discomfort, Dizziness, FormicationAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperventilation, may still occur.
Concerta Side Effect Report#9429144
Delirium, Incorrect Product Storage, Off Label Use, Agitation, Product Colour Issue
This Delirium problem was reported by a consumer or non-health professional from FR. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Concerta (dosage: NA). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Delirium, Incorrect Product Storage, Off Label Use, Agitation, Product Colour IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Delirium, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9418848
Hypertension, Dyspnoea, Muscle Spasms, Dizziness, Hot Flush, Palpitations, Hypoaesthesia, Paraesthesia, Depression
This Hypertension side effect was reported by a consumer or non-health professional from SE. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Concerta (drug dosage: NA), which was initiated on
Jun 07, 2012. Concurrently used drugs:
  • Magnesium
.After starting to take Concerta the consumer reported adverse symptoms, such as: Hypertension, Dyspnoea, Muscle Spasms, Dizziness, Hot Flush, Palpitations, Hypoaesthesia, Paraesthesia, DepressionThese side effects may potentially be related to Concerta. The patient was hospitalized.
Concerta Side Effect Report#9402966
Supraventricular Tachycardia, Atrioventricular Block, Electrocardiogram T Wave Inversion
This is a report of a 14-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Supraventricular Tachycardia, Atrioventricular Block, Electrocardiogram T Wave Inversion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Supraventricular Tachycardia side effect. The patient was hospitalized.
Concerta Side Effect Report#9401826
Memory Impairment, Tension Headache, Muscle Twitching
This report suggests a potential Concerta Memory Impairment side effect(s) that can have serious consequences. A 26-year-old male patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Concerta (dosage: NA) starting NS. After starting Concerta the patient began experiencing various side effects, including: Memory Impairment, Tension Headache, Muscle TwitchingAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Memory Impairment, may still occur.
Concerta Side Effect Report#9396073
Suicide Attempt, Agitation, Intentional Overdose, Aggression, Crying
This Suicide Attempt problem was reported by a physician from DE. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 30, 2013 this consumer started treatment with Concerta (dosage: 20 Tablets Of 27 Mg). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Suicide Attempt, Agitation, Intentional Overdose, Aggression, CryingThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicide Attempt, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9382291
Hyperthyroidism
This Hyperthyroidism side effect was reported by a consumer or non-health professional from FR. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: HyperthyroidismThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9379549
Off Label Use
This is a report of a 20-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Concerta (dosage: NA, start time: NS), combined with:
  • Methylphenidate Hydrochloride
and developed a serious reaction and side effect(s): Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Off Label Use side effect.
Concerta Side Effect Report#9377076
Poisoning, Aggression, Blood Creatinine Increased, Myoglobin Blood Increased
This report suggests a potential Concerta Poisoning side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Concerta (dosage: NA) starting NS. After starting Concerta the patient began experiencing various side effects, including: Poisoning, Aggression, Blood Creatinine Increased, Myoglobin Blood IncreasedAdditional drugs used concurrently:
  • Alcohol
The patient was hospitalized. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Concerta Side Effect Report#9372839
Withdrawal Syndrome, Headache, Discomfort
This Withdrawal Syndrome problem was reported by a consumer or non-health professional from SE. A 23-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On NS this consumer started treatment with Concerta (dosage: 1 Tablet Of 54 Mg In The Morning And One Tablet Of 18 Mg At Lunch.). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Withdrawal Syndrome, Headache, DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Withdrawal Syndrome, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9366429
Abortion Spontaneous, Uterine Dilation And Curettage, Exposure During Pregnancy
This Abortion Spontaneous side effect was reported by a physician from DK. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta (drug dosage: NA), which was initiated on
Sep 07, 2011. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Abortion Spontaneous, Uterine Dilation And Curettage, Exposure During PregnancyThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9363772
Psychotic Disorder
This is a report of a 17-year-old male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Psychotic Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Psychotic Disorder side effect. The patient was hospitalized.


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The appearance of Concerta on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Concerta Side Effects for Women?

Women Side Effects Reports
Suicide Attempt 57
Tachycardia 44
Depression 43
Insomnia 43
Headache 40
Suicidal Ideation 39
Weight Decreased 39
Overdose 35
Growth Retardation 32
Intentional Overdose 32

What are common Concerta Side Effects for Men?

Men Side Effects Reports
Aggression 122
Headache 105
Suicidal Ideation 105
Depression 87
Growth Retardation 83
Decreased Appetite 80
Insomnia 80
Hallucination 79
Chest Pain 76
Abnormal Behaviour 75

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Concerta reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Concerta Safety Alerts, Active Ingredients, Usage Information

    NDC 50458-585
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name CONCERTA
    Name Methylphenidate hydrochloride
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    On market since 20000801
    Labeler Janssen Pharmaceuticals, Inc.
    Active Ingredient(s) METHYLPHENIDATE HYDROCHLORIDE
    Strength(s) 18
    Unit(s) mg/1
    Pharma Class Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

    Concerta Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3043

    Concerta safety alerts: No

    Reported deaths: 83

    Reported hospitalizations: 730

    Latest Concerta clinical trials