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#9560623
Collagen Disorder, Off Label Use
This is a report of a 28-year-old female 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): Collagen Disorder, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in female patients, resulting in Collagen Disorder side effect.
Concerta Side Effect Report#9555809
Product Substitution Issue, Product Substitution Issue
This report suggests a potential Concerta Product Substitution Issue side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: 2 Pills) starting NS. After starting Concerta the patient began experiencing various side effects, including: Product Substitution Issue, Product Substitution IssueAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Substitution Issue, may still occur.
Concerta Side Effect Report#9555546
Insomnia, Malaise, Disturbance In Attention, Product Substitution Issue
This Insomnia problem was reported by a physician from US. A 9-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 Tab). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Insomnia, Malaise, Disturbance In Attention, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Insomnia, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9555400
Suicide Attempt, Intentional Overdose, Mood Altered, Crying, Tachycardia
This Suicide Attempt side effect was reported by a physician from DE. A 15-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Concerta (drug dosage: NA), which was initiated on
Sep 12, 2013. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Suicide Attempt, Intentional Overdose, Mood Altered, Crying, TachycardiaThese side effects may potentially be related to Concerta. The patient was hospitalized.
Concerta Side Effect Report#9555109
Agitation, Product Substitution Issue
This is a report of a 7-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: 1 Tablet, start time: 201208), combined with: NA. and developed a serious reaction and side effect(s): Agitation, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Agitation side effect.
Concerta Side Effect Report#9541416
Abnormal Behaviour, Condition Aggravated
This report suggests a potential Concerta Abnormal Behaviour side effect(s) that can have serious consequences. A 11-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder,autism and used Concerta (dosage: NA) starting 2009. After starting Concerta the patient began experiencing various side effects, including: Abnormal Behaviour, Condition AggravatedAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abnormal Behaviour, may still occur.
Concerta Side Effect Report#9533660
Cardiac Arrest
This Cardiac Arrest problem was reported by a physician from NL. A 16-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
Mar 14, 2013 this consumer started treatment with Concerta (dosage: Dose 1). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Cardiac ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9531693
Dysphoria, Gait Disturbance, Disturbance In Attention, Headache, Decreased Appetite, Malaise, Nausea, Vomiting, Anger
This Dysphoria side effect was reported by a physician from EE. A 11-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 201209. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Dysphoria, Gait Disturbance, Disturbance In Attention, Headache, Decreased Appetite, Malaise, Nausea, Vomiting, AngerThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9531594
Product Substitution Issue, Disturbance In Attention
This is a report of a 16-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: NA, start time:
May 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue, Disturbance In Attention 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#9531402
Urinary Retention
This report suggests a potential Concerta Urinary Retention side effect(s) that can have serious consequences. A 15-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting 200809. After starting Concerta the patient began experiencing various side effects, including: Urinary RetentionAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Retention, may still occur.
Concerta Side Effect Report#9524794
Product Substitution Issue, Product Substitution Issue, Product Quality Issue, Impaired Work Ability
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 25-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 (dosage: 1 Pill Once Daily Taken By Mouth). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Product Substitution Issue, Product Substitution Issue, Product Quality Issue, Impaired Work AbilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Substitution Issue, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9517777
Weight Decreased, Heart Rate Increased
This Weight Decreased side effect was reported by a physician from AU. A 23-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Concerta (drug dosage: 27mg-36 Mg Depending On The Day He Choose.), which was initiated on NS. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Weight Decreased, Heart Rate IncreasedThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9507581
Product Substitution Issue, Product Quality Issue
This is a report of a 6-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: 1 Pill Once Daily Taken By Mouth, start time:
Aug 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue, Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in female patients, resulting in Product Substitution Issue side effect.
Concerta Side Effect Report#9499643
Product Substitution Issue
This report suggests a potential Concerta Product Substitution Issue side effect(s) that can have serious consequences. A 10-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Concerta (dosage: #30 Qd Po) starting NS. After starting Concerta the patient began experiencing various side effects, including: Product Substitution IssueAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Substitution Issue, may still occur.
Concerta Side Effect Report#9496359
Foot Fracture, Pain, Swelling, Growth Retardation
This Foot Fracture problem was reported by a consumer or non-health professional from US. A 10-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On 2013 this consumer started treatment with Concerta (dosage: NA). The following drugs were being taken at the same time:
  • Methylphenidate Hydrochloride (watson)
  • Loratadine
When using Concerta, the patient experienced the following unwanted symptoms/side effects: Foot Fracture, Pain, Swelling, Growth RetardationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Foot Fracture, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9493648
Complex Regional Pain Syndrome, Pain In Extremity, Anxiety
This Complex Regional Pain Syndrome side effect was reported by a physician from ZA. A 11-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
Jul 01, 2013. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Complex Regional Pain Syndrome, Pain In Extremity, AnxietyThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9490836
Embolism
This is a report of a 21-year-old male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: NA, who was treated with Concerta (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Embolism side effect. The patient was hospitalized.
Concerta Side Effect Report#9482687
Intraocular Pressure Increased, Visual Acuity Reduced
This report suggests a potential Concerta Intraocular Pressure Increased side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting 2007. After starting Concerta the patient began experiencing various side effects, including: Intraocular Pressure Increased, Visual Acuity ReducedAdditional drugs used concurrently:
  • Ritalin (Treated Since Diagnosis)
  • Dextroamphetamine
Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intraocular Pressure Increased, may still occur.
Concerta Side Effect Report#9476353
Diverticulitis
This Diverticulitis problem was reported by a consumer or non-health professional from FI. A 34-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: NA). The following drugs were being taken at the same time:
  • Melatonin (Every Night)
  • Zopinox (As Needed)
  • Kestine
When using Concerta, the patient experienced the following unwanted symptoms/side effects: DiverticulitisThe 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 Diverticulitis, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9472445
Product Substitution Issue
This Product Substitution Issue side effect was reported by a consumer or non-health professional from US. 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
Aug 01, 2003. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Product Substitution IssueThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9472200
Restlessness, Agitation, Aggression, Social Avoidant Behaviour, Condition Aggravated, Product Substitution Issue, Product Quality Issue
This is a report of a 12-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: NA, start time: 201308), combined with: NA. and developed a serious reaction and side effect(s): Restlessness, Agitation, Aggression, Social Avoidant Behaviour, Condition Aggravated, Product Substitution 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 Restlessness side effect.
Concerta Side Effect Report#9470105
Suicide Attempt, Intentional Overdose, Tachycardia, Muscle Spasms, Paraesthesia, Diarrhoea
This report suggests a potential Concerta Suicide Attempt side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Concerta (dosage: Total Dose: 540mg.30 Tablets.) starting NS. After starting Concerta the patient began experiencing various side effects, including: Suicide Attempt, Intentional Overdose, Tachycardia, Muscle Spasms, Paraesthesia, DiarrhoeaAdditional drugs used concurrently:
  • Ibuprofen (Total Dose: 18000mg.30 Tablets.)
  • Pantozol (Total Dose: 400mg.10 Tablets.)
  • Valerian (20 Tablets.)
  • Cefaclor (20 Tablets.)
The patient was hospitalized. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Concerta Side Effect Report#9467524
Product Substitution Issue, Nausea, Muscle Spasms, Abdominal Pain, Flatulence, Feeling Abnormal
This Product Substitution Issue problem was reported by a physician from US. A 16-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
Aug 16, 2013 this consumer started treatment with Concerta (dosage: One Qd Oral). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Product Substitution Issue, Nausea, Muscle Spasms, Abdominal Pain, Flatulence, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Substitution Issue, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9465609
Psychotic Disorder
This Psychotic Disorder side effect was reported by a consumer or non-health professional from SE. A 26-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 NS. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Psychotic DisorderThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9465605
Arteritis, Peripheral Coldness, Skin Discolouration, Sleep Disorder
This is a report of a 11-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder,constipation, who was treated with Concerta (dosage: NA, start time: 201301), combined with:
  • Macrogol (1 Pack In The Evening)
and developed a serious reaction and side effect(s): Arteritis, Peripheral Coldness, Skin Discolouration, Sleep Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in female patients, resulting in Arteritis side effect.


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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

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