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#9980926
Dependence, Suicidal Ideation, Constipation, Off Label Use
This is a report of a 46-year-old male patient (weight: NA) from ZA, suffering from the following health symptoms/conditions: depression, who was treated with Concerta (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dependence, Suicidal Ideation, Constipation, 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 Dependence side effect.
Concerta Side Effect Report#9961325
Growth Retardation, Treatment Noncompliance
This report suggests a potential Concerta Growth Retardation side effect(s) that can have serious consequences. A 17-year-old male patient (weight: NA) from US 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: Growth Retardation, Treatment NoncomplianceAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Growth Retardation, may still occur.
Concerta Side Effect Report#9959135
Product Substitution Issue, Product Quality Issue, Anxiety, Disturbance In Attention
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
Feb 24, 2014 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 Quality Issue, Anxiety, Disturbance In AttentionAlthough 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#9949367
Hallucination, Amnesia
This Hallucination side effect was reported by a physician from NL. A 17-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Concerta (drug dosage: NA), which was initiated on 201310. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Hallucination, AmnesiaThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9938099
Hepatitis Fulminant
This is a report of a 17-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta (dosage: NA, start time: 201205), combined with: NA. and developed a serious reaction and side effect(s): Hepatitis Fulminant after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Hepatitis Fulminant side effect. The patient was hospitalized.
Concerta Side Effect Report#9931708
Tachycardia, Palpitations, Bundle Branch Block Right, Atrioventricular Block Second Degree, Atrioventricular Block First Degree, Electrocardiogram Pr Prolongation
This report suggests a potential Concerta Tachycardia side effect(s) that can have serious consequences. A 12-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting 201209. After starting Concerta the patient began experiencing various side effects, including: Tachycardia, Palpitations, Bundle Branch Block Right, Atrioventricular Block Second Degree, Atrioventricular Block First Degree, Electrocardiogram Pr ProlongationAdditional drugs used concurrently:
  • Ritaline (Dose Depending)
The patient was hospitalized. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Concerta Side Effect Report#9928162
Sinus Tachycardia, Incorrect Dose Administered, Agitation
This Sinus Tachycardia problem was reported by a physician from DE. A 12-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 05, 2014 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: Sinus Tachycardia, Incorrect Dose Administered, AgitationThe 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 Sinus Tachycardia, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9925392
Spontaneous Penile Erection
This Spontaneous Penile Erection side effect was reported by a physician from ZA. A 6-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: Spontaneous Penile ErectionThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9924674
Haematuria
This is a report of a 15-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder,asthma, who was treated with Concerta (dosage: NA, start time:
Nov 07, 2012), combined with:
  • Pulmicort Turbuhaler
  • Risperidone
  • Avamys
  • Terbasmin Turbuhaler
and developed a serious reaction and side effect(s): Haematuria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta treatment in male patients, resulting in Haematuria side effect.
Concerta Side Effect Report#9921310
Affect Lability, Product Substitution Issue
This report suggests a potential Concerta 36mg Affect Lability side effect(s) that can have serious consequences. A 13-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta 36mg (dosage: 2 Tablets Qam Po) starting NS. After starting Concerta 36mg the patient began experiencing various side effects, including: Affect Lability, Product Substitution IssueAdditional drugs used concurrently: NA. Although Concerta 36mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Affect Lability, may still occur.
Concerta Side Effect Report#9916451
Depression, Blood Pressure Abnormal, Heart Rate Abnormal
This Depression problem was reported by a consumer or non-health professional from US. A 54-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: 2 1 Pills In Am/ 1@pm 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: Depression, Blood Pressure Abnormal, Heart Rate AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Depression, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9916300
Product Substitution Issue, Product Shape Issue
This Product Substitution Issue side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta Er (drug dosage: NA), which was initiated on
Jul 01, 2013. Concurrently used drugs: NA..After starting to take Concerta Er the consumer reported adverse symptoms, such as: Product Substitution Issue, Product Shape IssueThese side effects may potentially be related to Concerta Er.
Concerta Side Effect Report#9916282
Product Substitution Issue
This is a report of a 19-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta, 54 Mg (dosage: NA, start time:
Jan 26, 2014), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta, 54 Mg treatment in male patients, resulting in Product Substitution Issue side effect.
Concerta Side Effect Report#9914372
Hunger, Product Substitution Issue, Loss Of Employment, Disturbance In Attention
This report suggests a potential Concerta Hunger side effect(s) that can have serious consequences. A 28-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
Jan 03, 2014. After starting Concerta the patient began experiencing various side effects, including: Hunger, Product Substitution Issue, Loss Of Employment, Disturbance In AttentionAdditional drugs used concurrently: NA. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hunger, may still occur.
Concerta Side Effect Report#9914362
Product Quality Issue, Product Substitution Issue
This Product Quality Issue problem was reported by a consumer or non-health professional from US. A 11-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On NS this consumer started treatment with Concerta (dosage: 1 Pill Once Daily). The following drugs were being taken at the same time: NA. When using Concerta, the patient experienced the following unwanted symptoms/side effects: Product Quality Issue, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Quality Issue, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9913649
Abnormal Behaviour
This Abnormal Behaviour side effect was reported by a physician from ZA. A 9-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: Abnormal BehaviourThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9909774
Product Substitution Issue
This is a report of a 30-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, start time:
Feb 03, 2014), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution 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#9908382
Amylase Increased, Gastrointestinal Pain, Lipase Increased
This report suggests a potential Concerta Amylase Increased side effect(s) that can have serious consequences. A 15-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: disturbance in attention and used Concerta (dosage: NA) starting
Dec 14, 2013. After starting Concerta the patient began experiencing various side effects, including: Amylase Increased, Gastrointestinal Pain, Lipase IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Amylase Increased, may still occur.
Concerta Side Effect Report#9906225
Product Substitution Issue
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 8-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
Oct 14, 2013 this consumer started treatment with Concerta (dosage: 1 Once Daily). 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 IssueAlthough 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#9902783
Hypothyroidism, Asthenia, Weight Decreased
This Hypothyroidism side effect was reported by a physician from ES. A 17-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
Feb 21, 2013. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Hypothyroidism, Asthenia, Weight DecreasedThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9902781
Intracranial Pressure Increased, Facial Pain, Swelling Face
This is a report of a 23-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Concerta Xl (dosage: NA, start time: NS), combined with:
  • Mirtazapine
  • Aripiprazole
and developed a serious reaction and side effect(s): Intracranial Pressure Increased, Facial Pain, Swelling Face after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Concerta Xl treatment in female patients, resulting in Intracranial Pressure Increased side effect.
Concerta Side Effect Report#9899497
Trichotillomania
This report suggests a potential Concerta Trichotillomania side effect(s) that can have serious consequences. A 11-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder and used Concerta (dosage: NA) starting
Aug 19, 2013. After starting Concerta the patient began experiencing various side effects, including: TrichotillomaniaAdditional drugs used concurrently:
  • Elvanse
The patient was hospitalized. Although Concerta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Trichotillomania, may still occur.
Concerta Side Effect Report#9891244
Rash
This Rash problem was reported by a consumer or non-health professional from US. A 7-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: attention deficit/hyperactivity disorder. On
Jan 24, 2014 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: RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Concerta Side Effect Report#9890854
Aggression, Anger, Incorrect Dose Administered, Product Substitution Issue
This Aggression side effect was reported by a consumer or non-health professional from US. A 7-year-old male patient (weight:NA) experienced the following symptoms/conditions: attention deficit/hyperactivity disorder.The patient was prescribed Concerta (drug dosage: 1 Pill Once Daily Taken By Mouth), which was initiated on
Jan 08, 2014. Concurrently used drugs: NA..After starting to take Concerta the consumer reported adverse symptoms, such as: Aggression, Anger, Incorrect Dose Administered, Product Substitution IssueThese side effects may potentially be related to Concerta.
Concerta Side Effect Report#9889104
Product Substitution Issue, Anxiety, Product Substitution Issue, Emotional Disorder, Educational Problem
This is a report of a 10-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: NS), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue, Anxiety, Product Substitution Issue, Emotional Disorder, Educational Problem 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.


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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