Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
rapid heart rate, tremors or shaking;
confusion, extreme fear, thoughts of hurting yourself;
agitation, hallucinations, fever, overactive reflexes, vomiting, diarrhea, loss of coordination, fainting;
painful or difficult urination;
very stiff (rigid) muscles;
seizure (convulsions), or
tired feeling, weakness, easy bruising or bleeding (nosebleed, bleeding gums), pale skin, feeling light-headed or short of breath.
Common side effects may include:
dry mouth, nausea, upset stomach, loss of appetite, constipation;
feeling anxious, restless, dizzy, drowsy, or tired;
sleep problems (insomnia);
appetite or weight changes;
memory problems, trouble concentrating;
increased sweating, numbness or tingling;
vision changes; or
decreased sex drive, impotence, or difficulty having an orgasm.
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 Equinorm in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Commonly Observed
The most commonly observed adverse events associated with the use of Equinorm and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.
Leading To Discontinuation Of Treatment
Approximately 20% of 3616 patients who received Equinorm in U.S. premarketing clinical trials discontinued treatment because of an adverse event. Approximately one-half of the patients who discontinued (9% of the total) had multiple complaints, none of which could be classified as primary. Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence. The second-most-frequent reason for discontinuation was digestive system complaints (1.3%), primarily vomiting and nausea.
There was no apparent relationship between the adverse events and elevated plasma drug concentrations.
Incidence In Controlled Clinical Trials
The following table enumerates adverse events that occurred at an incidence of 1% or greater among patients with OCD who received Equinorm in adult or pediatric placebo-controlled clinical trials. The frequencies were obtained from pooled data of clinical trials involving either adults receiving Equinorm (N=322) or placebo (N=319) or children treated with Equinorm (N=46) or placebo (N=44). The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that 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, provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the populations studied.
Incidence of Treatment-Emergent Adverse Experience in Placebo-Controlled Clinical Trials (Percentage of Patients Reporting Event)
Body System/ Adverse Event*
Adults
Children and Adolescents
Equinorm
(N=322)
Placebo
(N=319)
Equinorm
(N=46)
Placebo
(N=44)
Nervous System
Somnolence
54
16
46
11
Tremor
54
2
33
2
Dizziness
54
14
41
14
Headache
52
41
28
34
Insomnia
25
15
11
7
Libido change
21
3
-
-
Nervousness
18
2
4
2
Myoclonus
13
-
2
-
Increased appetite
11
2
-
2
Paresthesia
9
3
2
2
Memory impairment.
9
1
7
2
Anxiety
9
4
2
-
Twitching
7
1
4
5
Impaired concentration
5
2
-
-
Depression
5
1
-
-
Hypertonia
4
1
2
-
Sleep disorder
4
-
9
5
Psychosomatic disorder
3
-
-
-
Yawning
3
-
-
-
Confusion
3
-
2
-
Speech disorder
3
-
-
-
Abnormal dreaming
3
-
-
2
Agitation
3
-
-
-
Migraine
3
-
-
-
Depersonalization
2
-
2
-
Irritability
2
2
2
-
Emotional lability
2
-
-
2
Panic reaction
1
-
2
-
Aggressive reaction
-
-
2
-
Paresis
-
-
2
-
Skin and Appendages
Increased sweating
29
3
9
-
Rash
8
1
4
2
Pruritus
6
-
2
2
Dermatitis
2
-
-
2
Acne
2
2
-
5
Dry skin
2
-
-
5
Urticaria
1
-
-
-
Abnormal skin odor
-
-
2
-
Digestive System
Dry mouth
84
17
63
16
Constipation
47
11
22
9
Nausea
33
14
9
11
Dyspepsia
22
10
13
2
Diarrhea
13
9
7
5
Anorexia
12
-
22
2
Abdominal pain
11
9
13
16
Vomiting
7
2
7
-
Flatulence
6
3
-
2
Tooth disorder
5
-
-
-
Gastrointestinal disorder
2
-
-
2
Dysphagia
2
-
-
-
Esophagitis
1
-
-
-
Eructation
-
-
2
2
Ulcerative stomatitis
-
-
2
-
Body as a Whole
Fatigue
39
18
35
9
Weight increase
18
1
2
-
Flushing
8
-
7
-
Hot flushes
5
-
2
-
Chest pain
4
4
7
-
Fever
4
-
2
7
Allergy
3
3
7
5
Pain
3
2
4
2
Local edema
2
4
-
-
Chills
2
1
-
-
Weight decrease
-
-
7
-
Otitis media
-
-
4
5
Asthenia
-
-
2
-
Halitosis
-
-
2
-
Cardiovascular System
Postural hypotension
6
-
4
-
Palpitation
4
2
4
-
Tachycardia
4
-
2
-
Syncope
-
-
2
-
Respiratory System
Pharyngitis
14
9
-
5
Rhinitis
12
10
7
9
Sinusitis
6
4
2
5
Coughing
6
6
4
5
Bronchospasm
2
-
7
2
Epistaxis
2
-
-
2
Dyspnea
-
-
2
-
Laryngitis
-
1
2
-
Urogenital System
Male and Female Patients C'ombined
Micturition disorder
14
2
4
2
Urinary tract infection
6
1
-
-
Micturition frequency
5
3
-
-
Urinary retention
2
-
7
-
Dysuria
2
2
-
-
Cystitis
2
-
-
-
Female Patients Only
(N=182)
(N=167)
(N=10)
(N=21)
Dysmenorrhea
12
14
10
10
Lactation (nonpuerperal)
4
-
-
-
Menstrual disorder
4
2
-
-
Vaginitis
2
-
-
-
Leukorrhea
2
-
-
-
Breast enlargement
2
-
-
-
Breast pain
1
-
-
-
Amenorrhea
1
-
-
-
Male Patients Only
(N=140)
(N=152)
(N=36)
(N=23)
Ejaculation failure
42
2
6
-
Impotence
20
3
-
-
Special Senses
Abnormal vision
18
4
7
2
Taste perversion
8
-
4
-
Tinnitus
6
-
4
-
Abnormal lacrimation
3
2
-
-
Mydriasis
2
-
-
-
Conjunctivitis
1
-
-
-
Anisocoria
-
-
2
-
Blepharospasm
-
-
2
-
Ocular allergy
-
-
2
-
Vestibular disorder
-
-
2
2
Musculoskeletal
Myalgia
13
9
-
-
Back pain
6
6
-
-
Arthralgia
3
5
-
-
Muscle weakness
1
-
2
-
Hemic and Lymphatic
Purpura
3
-
-
-
Anemia
-
-
2
2
Metabolic and Nutritional
Thirst
2
2
-
2
*Events reported by at least 1% of Equinorm patients are included.
Other Events Observed During The Premarketing Evaluation Of Equinorm
During clinical testing in the U.S., multiple doses of Equinorm were administered to approximately 3600 subjects. Untoward events associated with this exposure were 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 untoward events into a smaller number of standardized event categories.
In the tabulations that follow, a modified World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the 3525 individuals exposed to Equinorm who experienced an event of the type cited on at least one occasion while receiving Equinorm. All events are included except those already listed in the previous table, those reported in terms so general as to be uninformative, and those in which an association with the drug was remote. It is important to emphasize that although the events reported occurred during treatment with Equinorm, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients.
Body as a Whole –Infrequent - general edema, increased susceptibility to infection, malaise. Rare - dependent edema, withdrawal syndrome.
The following adverse drug reaction has been reported during post-approval use of Equinorm. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency.
Eye Disorders – angle-closure glaucoma.
Drug Abuse And Dependence
Equinorm has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While a variety of withdrawal symptoms have been described in association with Equinorm discontinuation, there is no evidence for drug-seeking behavior, except for a single report of potential Equinorm abuse by a patient with a history of dependence on codeine, benzodiazepines, and multiple psychoactive drugs. The patient received Equinorm for depression and panic attacks and appeared to become dependent after hospital discharge.
Despite the lack of evidence suggesting an abuse liability for Equinorm in foreign marketing, it is not possible to predict the extent to which Equinorm might be misused or abused once marketed in the U.S. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
What is the most important information I should know about Equinorm?
Equinorm may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Equinorm with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with the doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Equinorm; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Equinorm may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Do not become overheated in hot weather or while you are being active; heatstroke may occur.
Children, teenagers, and young adults who take Equinorm may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch all patients who take Equinorm closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Serotonin syndrome is a possibly fatal syndrome that can be caused by Equinorm. Your risk may be greater if you take Equinorm with certain other medicines (eg, "triptans," MAOIs, SSRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
Some people may be at risk for eye problems from Equinorm. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
Equinorm may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Equinorm. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Tell your doctor or dentist that you take Equinorm before you receive any medical or dental care, emergency care, or surgery.
Lab tests, including complete blood cell counts, may be performed while you use Equinorm. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Equinorm with caution in the ELDERLY; they may be more sensitive to its effects, especially those with heart problems.
Equinorm should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Equinorm can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Equinorm while you are pregnant. Equinorm is found in breast milk. Do not breast-feed while taking Equinorm.
If you stop taking Equinorm suddenly, you may have WITHDRAWAL symptoms. These may include dizziness, headache, irritability, nausea, tiredness, trouble sleeping, and vomiting.
Equinorm contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Equinorm is contraindicated in patients with a history of hypersensitivity to Equinorm or other tricyclic antidepressants.
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Equinorm or within 14 days of stopping treatment with Equinorm is contraindicated because of an increased risk of serotonin syndrome. The use of Equinorm within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
Starting Equinorm in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
Myocardial Infarction
Equinorm is contraindicated during the acute recovery period after a myocardial infarction.
References
DTP/NCI. "clomipramine: 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. "Clomipramine: 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).
The results of a survey conducted on ndrugs.com for Equinorm 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 Equinorm. 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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