What are the possible side effects of Anfetamina?
Get emergency medical help if you have signs of an allergic reaction to Anfetamina: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Anfetamina and call your doctor at once if you have:
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chest pain, trouble breathing, feeling like you might pass out;
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fast heartbeats, rapid breathing;
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confusion, unusual thoughts, paranoia, hallucinations (seeing or hearing things that are not real);
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new behavior problems, aggression, anger, feeling irritable;
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numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
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changes in your vision; or
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unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).
Anfetamina can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common Anfetamina side effects may include:
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stomach pain, nausea, vomiting, loss of appetite;
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diarrhea, constipation;
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weight loss;
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mood changes, feeling restless or nervous, sleep problems (insomnia);
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dry mouth, unusual or unpleasant taste in the mouth;
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runny nose, nosebleeds;
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increased heart rate;
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headache, dizziness;
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itching; or
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impotence, sexual problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Anfetamina in details
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Drug Dependence
- Hypersensitivity to Anfetamina, or other components of Anfetamina
- Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
- Serious Cardiovascular Reactions
- Blood Pressure and Heart Rate Increases
- Psychiatric Adverse Reactions
- Long-Term Suppression of Growth
- Peripheral Vasculopathy, including Raynaud's phenomenon
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials Experience With Other Anfetamina Products In Pediatric Patients And Adults With ADHD
Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic Anfetamina use.
Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.
Eye Disorders: Vision blurred, mydriasis.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Endocrine: Impotence, changes in libido.
Skin: Alopecia.
Clinical Trials Experience With Anfetamina In Pediatric Patients With ADHD
There is limited experience with Anfetamina in controlled trials. Based on this limited experience, the adverse reaction profile of Anfetamina appears similar to other Anfetamina extended-release products. The most common ( ≥ 2% in the Anfetamina group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.
Table 1: Common adverse reactions occurring in ≥ 2% of Subjects on Anfetamina and greater than Placebo during the double blind phase.
Preferred Term | DYANAVELXR (N=52) | Placebo (N=48) |
Respiratory, thoracic and mediastinal disorders | ||
Epistaxis | 3.8% | 0% |
Rhinitis allergic | 3.8% | 0% |
Gastrointestinal disorders | ||
Abdominal pain upper | 3.8% | 2.1% |
Postmarketing Experience
The following adverse reactions have been identified during post approval use of other Anfetamina products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Endocrine: frequent or prolonged erections.
Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.
Psychiatric Disorders: dermatillomania.
What is the most important information I should know about Anfetamina?
- Tell your doctor or dentist that you take Anfetamina before you receive any medical or dental care, emergency care, or surgery.
- Anfetamina may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Anfetamina with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
- Anfetamina may cause sleeplessness. Do not take Anfetamina near your bedtime unless your doctor tells you otherwise.
- Anfetamina may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
- Anfetamina may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Anfetamina.
- You may need to have some heart tests before starting Anfetamina. Discuss any questions or concerns with your doctor.
- Check your blood pressure and heart rate as your doctor has told you. Discuss any questions or concerns with your doctor.
- Lab tests may be performed while you use Anfetamina. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Anfetamina should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- Anfetamina may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Anfetamina.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anfetamina while you are pregnant. Anfetamina is found in breast milk. Do not breast-feed while taking Anfetamina.
When used for long periods of time or at high doses, Anfetamina may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Anfetamina stops working well. Do not take more than prescribed.
Some people who use Anfetamina for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Anfetamina, you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.
Anfetamina contraindications
Anfetamina extended-release oral suspension is contraindicated:
- In patients known to be hypersensitive to Anfetamina, or other components of Anfetamina extended-release oral suspension. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other Anfetamina products.
- In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
References
- DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "AMPHETAMINE: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Amphetamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Anfetamina are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Anfetamina. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology