View Full Version : Focalin experience


DazdandConfused
02-18-14, 12:29 AM
Hi all, I am new here and new to Focalin. I was diagnosed with ADHD really late in life at 26. I had a diagnosis of a severe anxiety disorder for most of my life, none of the meds worked and the ones that did were usually zombie producing (xanax). I got my ADHD diagnosis surprisingly from a new doctor I went to see and she started me on 10mg of Focalin XR and Clonopin as needed for my panic attacks. Saturday morning I took Focalin for the first time and when it started to work I actually cried. I have never had my brain feel so still, never felt so normal. I always described my thought process as living life with a blender in your head. So loud and violent internally, hard to make decisons, hard to rest, hard to have peace. Well on Focalin for the past 72 hours I have found peace :o My only gripe is that around 2-4pm I get this dull odd nausea. It isn't world altering but it is steady enough that I lay down and feel pretty ill. Is this normal? Will it go away? I love Focalin, I would marry it if I could, but my day extends well beyond 2pm and I need my tummy to cooperate!


Please share any tips tricks or experiences with this med!

Niekiletta
03-10-14, 10:11 AM
If you are as happy as you say with your medication, I would suggest treating the side effect. In my experience the best treatment for mild nausea is ginger which is available fresh, powdered as a spice, as a supplement, in chews, as extract, ..........

Erika.Erika
03-17-14, 03:42 PM
My son has just switched to Focalin XR 10mg (from Concerta 18mg) and has had the same issues with feeling nauseous at about the time it starts to wear off. We've stocked up on saltines and ginger ale and hope to ease him through the crashes.

I am curious to see of anyone knows if the 'crash' ever goes away after taking the Rx for a while or if this will be the norm for the duration.

DJC-77
03-21-14, 08:12 PM
Focalin has been a lifesaver for me .

snowman2882
04-15-14, 11:29 PM
does anyone know where i can get coupons for focalin xr. It is so expensive and I have no insurance

TheNarrator
04-30-14, 12:16 PM
You might change your eating habits as it relates to when you take the meds and when they wear off. Maybe a snack before the nausea starts or maybe eat lunch sooner or later? Just a thought, I have not tried Focalin yet but I going to ask my doc to switch me.

How much are you finding it costs without insurance, as I am in the same boat.

merrell29er
05-18-14, 12:21 AM
does anyone know where i can get coupons for focalin xr. It is so expensive and I have no insurance
http://www.focalinxr.com/info/savings.jsp

ADHD40
02-09-17, 05:18 AM
I have recently switched from Vyvanse 60 too Adderall 20 3×day, I am curious about Focalin. Is it better than Adderall it? I heard it's strong and works well for adults?

ajaxblu
02-17-17, 11:50 AM
Hi, I have the same question as the OP: Does anyone know if the nausea from Focalin lessens over days or weeks after taking for a while?

I had dull headaches every day with Ritalin (which was my first ADD script and I'd been trying it for one month). The headaches weren't a deal-breaker for me as they went away with Ibuprofen or were some days dull enough that I could ignore them. But my dr didn't like that side effect so switched me to Focalin.

Now I have the nausea the OP described - I'd rather have the headaches unless the nausea is temporary. To be fair, I'm only in my first week of Focalin.

Thanks for any replies.

sarahsweets
02-17-17, 02:53 PM
Here is what I found.


Focalin XR (dexmethylphenidate hydrochloride) is a mild central nervous system (CNS) stimulant used to treat attention deficit hyperactivity disorder (ADHD). Common side effects of Focalin XR include:

trouble sleeping (insomnia),
dizziness,
dry mouth,
sore throat,
heartburn,
nausea,
stomach pain,
upset stomach,
headache,
nervousness,
restlessness,
anxiety,
feeling jittery,
loss of appetite, or
weight loss.
Tell your doctor if you experience serious side effects of Focalin XR including:

numbness/pain/skin color change/sensitivity to temperature in the fingers or toes,
fast/pounding/irregular heartbeat,
mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide),
uncontrolled muscle movements (such as twitching, shaking),
sudden outbursts of words or sounds that are hard to control, or
vision changes (such as blurred vision).

SIDE EFFECTS: Trouble sleeping, nervousness, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: numbness/pain/skin color change/sensitivity to temperature in the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision).

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.





Focalin XR FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS

Focalin XR was administered to 46 children and 7 adolescents with ADHD for up to 7 weeks and 206 adults with ADHD in clinical studies. During the clinical studies, 101 adult patients were treated for at least 6 months.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Events Associated With Discontinuation Of Treatment In Acute Clinical Studies With Focalin XR-Children

Overall, 50 of 684 children treated with Focalin immediate-release formulation (7.3%) experienced an adverse event that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each). None of the 53 Focalin XR-treated pediatric patients discontinued treatment due to adverse events in the 7-week, placebo-controlled study.

Adverse Events Occurring At An Incidence Of 5% Or More Among Focalin XR-Treated Patients-Children

Table 1 enumerates treatment-emergent adverse events for the placebo-controlled, parallel-group study in children and adolescents with ADHD at flexible Focalin XR doses of 5-30 mg/day. The table includes only those events that occurred in 5% or more of patients treated with Focalin XR and for which the incidence in patients treated with Focalin XR was at least twice the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence rate in the population studied.

Table 1: Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment-Pediatric Patients
F OCALIN XR
N=53 PLACEBO
N=47
No. of Patients with AEs
Total 76% 57%
Primary System Organ Class/Adverse Event Preferred Term
Gastrointestinal Disorders 38% 19%
Dyspepsia 8% 4%
Metabolism and Nutrition Disorders 34% 11%
Decreased Appetite 30% 9%
Nervous System Disorders 30% 13%
Headache 25% 11%
Psychiatric Disorders 26% 15%
Anxiety 6% 0%
1Events, regardless of causality, for which the incidence for patients treated with Focalin XR was at least 5% and twice the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.
Table 2 below enumerates the incidence of dose-related adverse events that occurred during a fixed-dose, double-blind, placebo-controlled trial of Focalin XR up to 30mg/day versus placebo in children and adolescents with ADHD.

Table 2: Dose-related Adverse Events from a Fixed-dose Study of Double-Blind Treatment in Pediatric Patients by Organ-System and Preferred Term
ADVERSE EVENT FOCALIN XR 10 MG/D
N=64 FOCALIN XR 20 MG/D
N=60 FOCALIN XR 30 MG/D
N=58 PLACEBO
N=63
Gastrointestinal Disorders 22% 23% 29% 24%
Vomiting 2% 8% 9% 0
Metabolism and Nutritional Disorders 16% 17% 22% 5%
Anorexia 5% 5% 7% 0
Psychiatric Disorders 19% 20% 38% 8%
Insomnia 5% 8% 17% 3%
Depression 0 0 3% 0
Mood Swings 0 0 3% 2%
Other Adverse Events
Irritability 0 2% 5% 0
Nasal Congestion 0 0 5% 0
Pruritus 0 0 3% 0
Adverse Events Associated With Discontinuation Of Treatment In Clinical Studies With Focalin XR-Adults

In the adult placebo-controlled study, 10.7% of the Focalin XR-treated patients and 7.5% of the placebo-treated patients discontinued for adverse events. Among Focalin XR-treated patients, insomnia (1.8%, n=3), feeling jittery (1.8%, n=3), anorexia (1.2%, n=2), and anxiety (1.2%, n=2) were the reasons for discontinuation reported by more than 1 patient.

Adverse Events Occurring At An Incidence Of 5% Or More Among Focalin XR-Treated Patients-Adults

Table 3 enumerates treatment-emergent adverse events for the placebo-controlled, parallel-group study in adults with ADHD at fixed Focalin XR doses of 20, 30, and 40 mg/day. The table includes only those events that occurred in 5% or more of patients in a Focalin XR dose group and for which the incidences in patients treated with Focalin XR appeared to increase with dose. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 3: Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment-Adults
FOCALIN XR 20 MG
N=57 FOCALIN XR 30 MG
N=54 FOCALIN XR 40 MG
N=54 PLACEBO
N=53
No. of Patients with AEs
Total 84% 94% 85% 68%
Primary System Organ Class/ Adverse Event Preferred Term
Gastrointestinal Disorders 28% 32% 44% 19%
Dry Mouth 7% 20% 20% 4%
Dyspepsia 5% 9% 9% 2%
Nervous System Disorders 37% 39% 50% 28%
Headache 26% 30% 39% 19%
Psychiatric Disorders 40% 43% 46% 30%
Anxiety 5% 11% 11% 2%
Respiratory, Thoracic and Mediastinal Disorders 16% 9% 15% 8%
Pharyngolaryngeal Pain 4% 4% 7% 2%
1Events, regardless of causality, for which the incidence was at least 5% in a Focalin XR group and which appeared to increase with randomized dose. Incidence has been rounded to the nearest whole number.
Two other adverse reactions occurring in clinical trials with Focalin XR at a frequency greater than placebo, but which were not dose related were: feeling jittery (12% and 2%, respectively) and dizziness (6% and 2%, respectively).

Table 4 summarizes changes in vital signs and weight that were recorded in the adult study (N=218) of Focalin XR in the treatment of ADHD.

Table 4: Changes (Mean ± SD) in Vital Signs and Weight by Randomized Dose During Double-Blind Treatment-Adults
F OCALIN XR 20 MG
(N=57) FOCALIN XR 30 MG
(N=54) FOCALIN XR 40 MG
(N=54) PLACEBO
(N=53)
Pulse (bpm) 3.1 ± 11.1 4.3 ± 11.7 6.0 ± 10.1 -1.4 ± 9.3
Diastolic BP (mmHg) -0.2 ± 8.2 1.2 ± 8.9 2.1 ± 8.0 0.3 ± 7.8
Weight (kg) -1.4 ± 2.0 -1.2 ± 1.9 -1.7 ± 2.3 -0.1 ± 3.9
Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of Focalin XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Musculoskeletal: rhabdomyolysis

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

Adverse Events With Other Methylphenidate HCl Dosage Forms

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include:

Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: abdominal pain, nausea

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Metabolism/Nutrition: anorexia, weight loss during prolonged therapy

Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette's syndrome, toxic psychosis

Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/Lymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

Psychiatric: transient depressed mood, aggressive behavior, libido changes

Skin/Subcutaneous: scalp hair loss

Urogenital: priapism

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a 10-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

Fraser_0762
02-17-17, 02:59 PM
People tend to ignore the importance of hydration when on stimulants. It's the same when you consume too much caffeine, but don't drink enough water. The dehydration effects can lead to headaches, sore stomachs and high blood pressure.

Just drink more water throughout the day.

ajaxblu
02-17-17, 04:35 PM
Thank you so much for the information, sarahsweets.

Good point about H2o, Fraser. Worth a try.

ajaxblu
02-20-17, 04:24 PM
After re-reading the thread, I realize I perhaps did not clarify my question properly....

Has anyone who has taken Focalin, and had nausea or headache or lethargy with it, noticed those symptoms go away or dissipate after taking it for a while?

Thanks

wmbower
03-17-17, 12:56 PM
Had a horrible experience with Focalin. It caused mania and psychosis. :(

I had pharmacogenetic testing done with Rxight Genetic Testing for ADHD Medications. It showed I was a rapid metabolizer of Focalin and therefore prone to toxicity and a build up in my system.

Bouncingoffwall
04-15-17, 02:22 AM
After re-reading the thread, I realize I perhaps did not clarify my question properly....

Has anyone who has taken Focalin, and had nausea or headache or lethargy with it, noticed those symptoms go away or dissipate after taking it for a while?

Thanks

I did experience headaches occasionally, but it was influenced by my level of water intake. As mentioned before, stay well hydrated. As to the lethargy, I always seemed to experience tiredness around 1 p.m. I think it was when the initial release of the XR wore off.