Other side effects including pain and pressure sensations have been reported (13% to 22%). These sensations have included chest pain/tightness/pressure and/or heaviness (2% to 4%), neck/throat/jaw pain/tightness/pressure (4% to 10%), heaviness other than the chest or neck (1% to 5%), pain from a specified location (2% to 3%), and other pressure/tightness/heaviness (2%). Atypical sensations (12% to 18%) including hypoesthesia (1% to 2%), paresthesia (5% to 9%), and warm/cold sensations (5% to 7%) have been reported. Hyperesthesia has been reported infrequently. Asthenia (3% to 9%), palpitations (up to 2%), myalgia (1% to 2%), myasthenia (up to 2%) and drug-induced headache have also been reported. Otic changes including hyperacusis, ear pain, parosmia, and tinnitus have been reported infrequently.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking zolmitriptan and call your doctor at once if you have any of these serious side effects: chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; sudden numbness or weakness, especially on one side of the body; sudden headache, confusion, problems with vision, speech, or balance; fast or pounding heartbeats, dizziness; sudden and severe stomach pain and bloody diarrhea; numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or (if you are also taking an antidepressant) - agitation, high fever, sweating, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting; Less serious side effects may include: dry mouth, upset stomach; feeling of pain or pressure in your neck or throat; drowsiness, weakness; or feeling of warmth. 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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Stop taking topiramate and call your doctor at once if you have any of these serious side effects: sudden vision loss, pain around or behind your eyes; dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or severe pain in your side or lower back, painful or difficult urination. Less serious side effects may include: slowed thinking, memory problems, trouble concentrating; problems with speech or balance; numbness or tingling; sleep problems (insomnia); tired feeling; headache, dizziness; or loss of appetite, weight loss. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

General side effects including fatigue, fever, and malaise have been reported to occur frequently. Oligohidrosis, pain, chest pain, and hyperthermia have also been reported.

Withdrawal symptoms may occur if tramadol is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol discontinuation have included panic attacks, severe anxiety, and paresthesias. Withdrawal symptoms may be avoided by tapering the drug at the time of discontinuation.

The FDA has informed healthcare professionals that the agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

Patients, their caregivers, and families should be counseled that antiepileptic drugs, including topiramate, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Side effects most often associated were related to the central nervous system. The most frequent of these can be classified into three categories: 1) cognitive related dysfunction (e.g. confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech, or language problems, particularly word finding difficulties), 2) psychiatric/behavior disturbances (e.g. depression or mood problems), and 3) somnolence or fatigue. The majority of cognitive-related adverse events were mild to moderate in severity and frequently occurred in isolation. Rapid titration rate and higher initial doses were associated with higher incidences of cognitive-related adverse events. Psychiatric/behavioral disturbances (depression or mood problems) were dose related. Somnolence and fatigue were the adverse events most frequently reported during clinical trials.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Stop taking topiramate and call your doctor at once if you have any of these serious side effects: sudden vision loss, pain around or behind your eyes; dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or severe pain in your side or lower back, painful or difficult urination. Less serious side effects may include: slowed thinking, memory problems, trouble concentrating; problems with speech or balance; numbness or tingling; sleep problems (insomnia); tired feeling; headache, dizziness; or loss of appetite, weight loss. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Other side effects including pain and pressure sensations have been reported (13% to 22%). These sensations have included chest pain/tightness/pressure and/or heaviness (2% to 4%), neck/throat/jaw pain/tightness/pressure (4% to 10%), heaviness other than the chest or neck (1% to 5%), pain from a specified location (2% to 3%), and other pressure/tightness/heaviness (2%). Atypical sensations (12% to 18%) including hypoesthesia (1% to 2%), paresthesia (5% to 9%), and warm/cold sensations (5% to 7%) have been reported. Hyperesthesia has been reported infrequently. Asthenia (3% to 9%), palpitations (up to 2%), myalgia (1% to 2%), myasthenia (up to 2%) and drug-induced headache have also been reported. Otic changes including hyperacusis, ear pain, parosmia, and tinnitus have been reported infrequently.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking zolmitriptan and call your doctor at once if you have any of these serious side effects: chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; sudden numbness or weakness, especially on one side of the body; sudden headache, confusion, problems with vision, speech, or balance; fast or pounding heartbeats, dizziness; sudden and severe stomach pain and bloody diarrhea; numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or (if you are also taking an antidepressant) - agitation, high fever, sweating, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting; Less serious side effects may include: dry mouth, upset stomach; feeling of pain or pressure in your neck or throat; drowsiness, weakness; or feeling of warmth. 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.

Nervous system side effects (11% to 21%) including dizziness (6% to 10%), somnolence (5% to 8%), and vertigo (up to 2%) have been reported. Agitation, anxiety, depression, emotional lability, and insomnia have also been reported infrequently. Akathisia, amnesia, apathy, ataxia, dystonia, euphoria, hallucinations, cerebral ischemia, hyperkinesia, hypotonia, hypertonia, and irritability have been reported rarely. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events including fatalities have been reported in patients treated with 5-HT1 agonists.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking zolmitriptan and call your doctor at once if you have any of these serious side effects: chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; sudden numbness or weakness, especially on one side of the body; sudden headache, confusion, problems with vision, speech, or balance; fast or pounding heartbeats, dizziness; sudden and severe stomach pain and bloody diarrhea; numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or (if you are also taking an antidepressant) - agitation, high fever, sweating, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting; Less serious side effects may include: dry mouth, upset stomach; feeling of pain or pressure in your neck or throat; drowsiness, weakness; or feeling of warmth. 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.

Musculoskeletal side effects including back pain, leg cramps, and tenosynovitis have been reported infrequently. Arthritis, tetany, myalgia, and twitching have been reported rarely.

Zolmitriptan can cause coronary vasospasm. Zolmitriptan should not be prescribed for patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's angina, or other significant underlying cardiovascular disease.

Acute myocardial infarction has been reported within a few hours following administration of zolmitriptan. Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following administration of other 5-HT1 agonists. Events have included coronary artery vasospasm, transient myocardial ischemia, ventricular tachycardia, and ventricular fibrillation.

Nervous system side effects (11% to 21%) including dizziness (6% to 10%), somnolence (5% to 8%), and vertigo (up to 2%) have been reported. Agitation, anxiety, depression, emotional lability, and insomnia have also been reported infrequently. Akathisia, amnesia, apathy, ataxia, dystonia, euphoria, hallucinations, cerebral ischemia, hyperkinesia, hypotonia, hypertonia, and irritability have been reported rarely. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events including fatalities have been reported in patients treated with 5-HT1 agonists.

MANAGEMENT: In general, the concomitant use of multiple serotonergic agents should be avoided if possible, or otherwise approached with caution if potential benefit is deemed to outweigh the risk. Patients should be closely monitored for symptoms of the serotonin syndrome during treatment. Particular caution is advised when increasing the dosages of these agents. The potential risk for serotonin syndrome should be considered even when administering serotonergic agents sequentially, as some agents may demonstrate a prolonged elimination half-life. For example, a 5-week washout period is recommended following use of fluoxetine before administering another serotonergic agent. If serotonin syndrome develops or is suspected during the course of therapy, all serotonergic agents should be discontinued immediately and supportive care rendered as necessary. Moderately ill patients may also benefit from the administration of a serotonin antagonist (e.g., cyproheptadine, chlorpromazine). Severe cases should be managed under consultation with a toxicologist and may require sedation, neuromuscular paralysis, intubation, and mechanical ventilation in addition to the other measures.

Serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Withdrawal symptoms may occur if tramadol is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol discontinuation have included panic attacks, severe anxiety, and paresthesias. Withdrawal symptoms may be avoided by tapering the drug at the time of discontinuation.

Other side effects including withdrawal symptoms and, rarely, auditory hallucinations have been reported. A case of vocal cord closure has also been reported.

Nervous system side effects occur frequently. Dizziness, headache, and somnolence have been reported in more than 25% of treated patients during the first three months of therapy. CNS stimulation, including nervousness, anxiety, tremor, agitation, euphoria, emotional lability and hallucinations, has also been reported. Confusion, sleep disorders, and coordination disturbances have been reported in less than 5% of patients. Seizures have been reported in over 200 cases. Cases of long-lasting delirium have been reported in two elderly patients. A case of serotonin syndrome triggered by tramadol has also been reported.

The cardiovascular side effects have included palpitations, peripheral vasodilatation and reflex tachycardia with blood pressure increasing or decreasing. Albuterol in higher dosages has been reported to aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving intravenous albuterol. Postmarketing reports have included hypotension.

Changes in heart rate of approximately 20% may be produced by 0.18 mg of albuterol by MDI. Aggravation of angina may be due to tachycardia produced by albuterol. Atrial fibrillation was reported in one patient when a spacer device was utilized with an albuterol inhaler, thus increasing the available dose for systemic absorption. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of albuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.