Aspidon/Aspidon OS

Aspidon/Aspidon OS Adverse Reactions

risperidone

Manufacturer:

Torrent

Distributor:

Torrent
Full Prescribing Info
Adverse Reactions
Aspidon: 1 mg: Commonly observed adverse effects are: Insomnia, agitation, anxiety and headache.
Less commonly observed effects are: Somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia, nausea, abdominal pain, blurred vision, erectile dysfunction, ejaculatory dysfunction, orgasmic dysfunction, rhinitis, rash. In addition to orthostatic hypotension, hypertension has been reported frequently.
The patient must seek medical attention immediately at the first sign of any adverse drug reaction.
2 mg: The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
The most common adverse reactions that were associated with discontinuation from clinical trials (causing discontinuation in >1% of adults and/or >2% of pediatrics) were nausea, somnolence, sedation, vomiting, dizziness, and akathisia.
The patient must seek medical attention immediately at the first sign of any adverse drug reaction shall appear.
Aspidon OS: Very common (affects more than 1 user in 10): Parkinsonism which is a medical term that includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex).
Headache, difficult falling or staying asleep.
Common (affects 1 in 10 users in 100): Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder.
Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth.
Weight increased, increase in body temperature, decreased appetite.
Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough.
Urinary tract infection, bed wetting.
Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs.
Rash, skin redness.
Fast beating heart, chest pain.
Blood prolactin hormone level increased.
Uncommon (affects 1 to 10 users in 1000): Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice disorder.
Lung infection caused by inhaling of food into the breathing passages, bladder infection, 'pink eye', sinus infection, viral infection, ear infection, tonsil infection, infection under the skin, eye infection, stomach infection, eye discharge, yeast infection of nails.
Abnormal electrical conduction of the heart, drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased.
Urinary incontinence, pain when passing urine, frequent passing of urine.
Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania), lack of energy and interest.
Blood sugar increased, liver enzymes increased, white blood cell count decreased, low hemoglobin or red blood cell count (anemia), increase in eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop bleeding).
Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort.
Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, reduced skin sensitivity to pain or touch, inflammation of oily skin.
No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge.
Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, feeling 'out of sorts', balance disorder, allergy, edema, speech disorder, chills, abnormal coordination.
Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in tears.
Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breathing, flu-like illness, sinus congestion.
Unresponsive to stimuli, loss of consciousness, sudden swelling of lips and eyes along with difficulty breathing, sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing in ears, face edema.
Rare (affects 1 to 10 users in 10,000): Inability to reach orgasm, menstrual disorder.
Dandruff.
Drug allergy, coldness in arms and legs, lip swelling, lip inflammation.
Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling.
Lack of emotion.
Change in consciousness with increased body temperature and twitching of muscles, edema all over the body, drug withdrawal syndrome, body temperature decreased.
Fast shallow breathing, trouble breathing during sleep, chronic otitis media (ear infection).
Obstruction of intestine.
Reduced blood flow to the brain.
Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume.
Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder.
Coma due to uncontrolled diabetes.
Yellowing of the skin and the eyes (jaundice).
Inflammation of the pancreas.
Very rare (affects less than 1 user in 10,000): Life threatening complications of uncontrolled diabetes.
Unknown frequency of occurrence (frequency cannot be estimated from the available data): Severe allergic reaction resulting in difficulty in breathing and shock.
No granulocytes (a type of white blood cell to help you against infection).
Prolonged and painful erection.
Dangerously excessive intake of water.
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If the patient notices any of these symptoms seek medical advice immediately.
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