Side effects of Nizagara® 50 / 100 mg

Adverse reactions of Nizagara® 50 / 100 mg

The most commonly reported adverse reactions were headache, hot flashes, dyspepsia, nasal congestion, back pain, dizziness, nausea, hot flashes, visual disturbances, cyanopsia, and blurred vision.

Adverse reactions are listed below according to the system-organ-class classification and frequency:

• very common (≥ 1/10)
• common (≥ 1/100 – < 1/10)
• infrequent (≥ 1000 – < 1/100)
• and rare (≥ 1/10000 – < 1/1000)

Within each frequency group, adverse reactions are listed in descending order of their manifestations.

Infections and infestations

• Infrequently: rhinitis.

From the immune system

• Infrequently hypersensitivity.

From the nervous system

• Very common: headache.

Often dizziness

• Infrequently: drowsiness, hypesthesia.
• Rare: stroke, transient ischemic attack, convulsions*, recurrent seizures*, syncope.

From the side of the visual organs

• Often: impaired color perception**, visual disturbances, blurred vision.
• Infrequently: lacrimation disorders***, eye pain, photophobia, photopsia, eye hyperemia, visual brightness, conjunctivitis.
• Rare: non-arterial anterior ischemic neuropathy of the optic nerve*, retinal vascular occlusion*, retinal hemorrhage, arteriosclerotic retinopathy, retinal disorders, glaucoma, visual field defects, diplopia, decreased visual acuity, myopia, asthenopia, floating opacities of the vitreous body, Iris disorders, mydriasis, the appearance of shining circles around a light source (Halo) in the visual field, eye edema, eye swelling, eye disorders, conjunctival hyperemia, eye irritation, abnormal sensations in the eyes, swelling of the eyelids, discoloration of the sclera.

From the side of the hearing organs and vestibular apparatus

• Infrequently dizziness, ringing in the ears.
• Rare: deafness.

From the side of the heart

• Infrequently: tachycardia, increased heart rate.
• Rare: sudden cardiac death*, myocardial infarction, ventricular arrhythmia*, atrial fibrillation, unstable angina.

From the side of blood vessels

• Often: flushes of blood to the face, hot flashes.
• Infrequently: hypertension, hypotension.

From the respiratory system, chest and mediastinal organs

• Common: nasal congestion.
• Infrequently: nosebleeds, sinus congestion.
• Rare: tightness in the throat, swelling of the nasal mucosa, dryness in the nose.

From the gastrointestinal tract

• Common: nausea, dyspepsia.
• Infrequently: gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth.
• Rarely hypesthesia of the oral cavity.

From the skin and subcutaneous tissue

• Infrequently: rash.
• Rare: Stevens-Johnson syndrome*, toxic epidermal necrolysis*.

From the musculoskeletal system and connective tissue

• Infrequently myalgia, pain in the extremities.

From the urinary system

• Infrequently: hematuria.

From the reproductive system and mammary glands

• Rare: penile bleeding, priapism*, hematospermia, prolonged erection.
• General disorders and reactions at the injection site.
• Infrequently: chest pain, increased fatigue, feeling hot.
• Rare: irritation.

Survey

• Infrequently: increased heart rate.

 

* Reported only during the study after sildenafil entered the market.

** Color perception disorders: chloropsia, chromatopsia, cyanopsia, erythropsia, xanthopsia.

*** Impaired lacrimation: dry eyes, impaired lacrimation, and increased lacrimation.

The following events were observed in < 2% of patients during the studies; the causal relationship was not determined. Reports included events that were likely associated with the use of sildenafil. The phenomena that were not noted were simple, and the reports were too inaccurate to matter.

Common: facial swelling, photosensitivity reactions, shock, asthenia, pain, sudden fall, abdominal pain, sudden injury.

From the cardiovascular system: angina pectoris, AV block, migraine, postural hypotension, myocardial ischemia, cerebral vascular thrombosis, sudden cardiac arrest, ECG abnormalities, cardiomyopathy.

From the gastrointestinal tract: glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, violation of the results of liver tests, rectal bleeding, gingivitis.

From the blood and lymphatic system: anemia, leukopenia.

Metabolic and nutritional disorders: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

Musculoskeletal disorders: arthritis, osteoarthritis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.

Nervous system disorders: ataxia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, abnormal dreams, decreased reflexes.

From the respiratory system: asthma, dyspnoea, laryngitis, pharyngitis, sinusitis, bronchitis, increased salivation, increased cough.

From the skin: urticaria, herpes, itching, sweating, skin ulcers, contact dermatitis, exfoliative dermatitis.

Specific sensations: sudden hearing loss or loss, ear pain, eye hemorrhage, cataracts, dry eyes.

From the urogenital system: cystitis, nocturia, increased frequency of urination, enlarged mammary glands, urinary incontinence, ejaculation disorders, genital edema, anorgasmia.

Adverse reactions reported from a population of unknown size. These phenomena were noted both because of their severity, frequency of reporting, lack of clear alternative communication, and because of a combination of these factors.

Cardiovascular and cerebrovascular phenomena. Serious cardiovascular, cerebrovascular, and vascular events, including cerebrovascular bleeding, subarachnoid and intracerebral bleeding, and pulmonary bleeding, have been reported over time with sildenafil use. Most patients, but not all, had cardiovascular risk factors. Many of these events have been reported to occur during or immediately after sexual activity, and several events have occurred immediately after using sildenafil without sexual activity. Other events occurred within hours or days of sildenafil use and sexual activity. It is not possible to determine whether these events are related to sildenafil use, sexual activity, existing risk factors, or a combination of these factors, or other factors.

From the circulatory and lymphatic systems: vaso-occlusive crisis. In a small pre-discontinued study of the use of sildenafil in patients with pulmonary arterial hypertension secondary to sickle cell anemia, the development of vaso-occlusive crises requiring hospitalization was reported more often with sildenafil than with placebo. The clinical significance of this information for patients using the drug for the treatment of erectile dysfunction is unknown.

Nervous system disorders: anxiety, transient global amnesia.

Specific sensations

From the side of the hearing organs. Cases of sudden hearing loss or loss associated with sildenafil use have been reported over time. In some cases, the presence of diseases and other factors that may play a role in the development of adverse hearing reactions has been reported. In many cases, there is no information about further medical supervision. It is not possible to determine whether these events are directly related to the use of sildenafil, existing risk factors for hearing loss, a combination of these factors, or other factors.

From the side of the visual organs: temporary loss of vision, redness of the eyes, burning in the eyes, increased intraocular pressure, retinal edema, retinal vascular diseases or bleeding, vitreous detachment.

Cases of non-arterial anterior ischemic optic neuropathy, which is the cause of vision loss, including permanent vision loss, have been reported that have been associated over time with the use of PDE5 inhibitors, including sildenafil. Many patients, but not all, had anatomical or vascular risk factors for developing non-arterial anterior ischemic neuropathy of the optic nerve, including (but not limited to) the following: low ratio of excavation diameter to the optic disc (congestive disc of the optic nerve), age from 50 years, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are directly related to the use of PDE5 inhibitors, or to existing anatomical or vascular risk factors, or to a combination of all these factors, or to other factors.

Reporting suspected adverse reactions. Reporting suspected adverse reactions after drug registration is important. This makes it possible to continuously monitor the ratio of benefits and risks associated with the use of this drug. Doctors should report any suspected adverse reactions in accordance with legal requirements.

Description of Sildenafil

The Latin name of the substance Sildenafil – Sildenafilum (genus Sildenafili)
Chemical name: 1 – [[3 – (6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-alpha]pyrimidine-5-yl) – 4-ethoxyphenyl] sulfonyl]piperazine citrate

Gross formula – C22H30N6O4S.C6H8O7