Dyanavel XR Side Effects
Generic name: amphetamine
Medically reviewed by Drugs.com. Last updated on Jan 7, 2021.
Note: This document contains side effect information about amphetamine. Some of the dosage forms listed on this page may not apply to the brand name Dyanavel XR.
For the Consumer
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet extended release disintegrating
Oral route (Suspension, Extended Release; Tablet, Extended Release, Disintegrating)
CNS stimulants, including amphetamine extended-release oral formulations, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Oral route (Tablet, Disintegrating)
CNS stimulants, including amphetamine sulfate orally disintegrating tablets, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Oral route (Tablet)
Abuse potential is high with the use of amphetamines. Using amphetamines for a prolonged period of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of patients obtaining amphetamines for distribution to others or for nontherapeutic use. Prescribe and dispense amphetamines sparingly. Sudden death and serious cardiovascular adverse events may occur with misuse of amphetamines.
Side effects requiring immediate medical attention
Along with its needed effects, amphetamine (the active ingredient contained in Dyanavel XR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking amphetamine:
- bladder pain
- bloody or cloudy urine
- delusions of persecution, mistrust, suspiciousness, or combativeness
- difficult, burning, or painful urination
- false or unusual sense of well-being
- feeling of unreality
- frequent urge to urinate
- lower back or side pain
- mental depression
- quick to react or overreact emotionally
- rapidly changing moods
- sense of detachment from self or body
- Seeing, hearing, or feeling things that are not there
- severe mental changes
Incidence not known
- Blistering, peeling, loosening of the skin
- blurred vision
- chest pain or discomfort
- dark urine
- difficulty breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- hives, itching, skin rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- mood swings
- muscle cramps, pain, stiffness, or spasms
- overactive reflexes
- pain or discomfort in the arms, jaw, back, or neck
- paleness or cold feeling in the fingertips and toes
- pounding in the ears
- red skin lesions, often with a purple center
- red, irritated eyes
- shakiness in the legs, arms, hands, or feet
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the feet or lower legs
- talking or acting with excitement you cannot control
- tingling or pain in the fingers or toes when exposed to cold temperatures
- trouble sleeping
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking amphetamine:
Symptoms of overdose
- dark urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast breathing
- fast, slow, or irregular heartbeat
- loss of consciousness
- muscle cramps, spasms, pain, or stiffness
- seeing, hearing, or feeling things that are not there
- stomach cramps
- unusual tiredness or weakness
Side effects not requiring immediate medical attention
Some side effects of amphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Dry mouth
- loss of appetite
- stomach ache
- voice changes
- weight loss
Incidence not known
- decreased interest in sexual intercourse
- difficulty having a bowel movement
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- redness of the skin
- thinning or loss of hair
- unpleasant taste
For Healthcare Professionals
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet disintegrating extended release
The most commonly reported side effects with amphetamine (the active ingredient contained in Dyanavel XR) products include dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.[Ref]
There have been isolated reports of cardiomyopathy associated with chronic amphetamine (the active ingredient contained in Dyanavel XR) use.[Ref]
Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy
Rare (less than 0.1%): Psychotic episodes
Frequency not reported: Euphoria, dysphoria, insomnia, restlessness, irritability, depression, aggression, anger, logorrhea, dermatillomania[Ref]
Postmarketing reports: Rhabdomyolysis[Ref]
Common (1% to 10%): Upper abdominal pain
Frequency not reported: Urticaria[Ref]
Frequency not reported: Anorexia, weight loss[Ref]
Postmarketing reports: Blurred vision, mydriasis[Ref]
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More about Dyanavel XR (amphetamine)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 26 Reviews
- Drug class: CNS stimulants
- FDA Approval History
Related treatment guides
1. "Product Information. Adzenys XR-ODT (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.
2. "Product Information. Evekeo ODT (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
3. "Product Information. Adzenys ER (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.
4. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
5. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc, Monmouth Junction, NJ.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.