Rozgra Side effects

• Side effects of Rozgra in details
• Rozgra contraindications
• Rozgra reviews

What are the possible side effects of Rozgra?

Get emergency medical help if you have signs of an allergic reaction to Rozgra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Rozgra and get emergency medical help if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• vision changes or sudden vision loss; or

• erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).

Call your doctor at once if you have:

• ringing in your ears, or sudden hearing loss;

• irregular heartbeat;

• swelling in your hands, ankles, or feet;

• shortness of breath;

• seizure (convulsions); or

• a light-headed feeling, like you might pass out.

Common Rozgra side effects may include:

• flushing (warmth, redness, or tingly feeling);

• headache, dizziness;

• abnormal vision (blurred vision, changes in color vision)

• stuffy nose;

• muscle pain, back pain; or

• upset stomach.

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 Rozgra in details

The following serious adverse events are discussed elsewhere in the labeling:

• Mortality with pediatric use
• Hypotension
• Vision loss
• Hearing loss
• Priapism
• Vaso-occlusive crisis

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety data of Rozgra in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Rozgra-treated patients with PAH, WHO Group I.

The overall frequency of discontinuation in Rozgra-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.

In Study 1, the adverse reactions that were reported by at least 3% of Rozgra-treated patients (20 mg three times a day) and were more frequent in Rozgra-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.

Table 1: Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Rozgra-Treated Patients than Placebo-Treated Patients and Incidence ≥ 3% in Rozgra-Treated Patients)

At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.

The incidence of retinal hemorrhage with Rozgra 20 mg three times a day was 1.4% versus 0% placebo and for all Rozgra doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for Rozgra versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.

In a placebo-controlled fixed dose titration study (Study 2) of Rozgra (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the Rozgra + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2.

Table 2: Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Rozgra + Epoprostenol group at least 6% greater than Epoprostenol group)

Rozgra Injection

Rozgra injection was studied in a 66-patient, placebo-controlled study in patients with PAH at doses targeting plasma concentrations between 10 and 500 ng/mL (up to 8 times the exposure of the recommended dose). Adverse events with Rozgra injection were similar to those seen with oral tablets.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Rozgra (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Events

In postmarketing experience with Rozgra at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Rozgra without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to Rozgra, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors.

Nervous system

Seizure, seizure recurrence

What is the most important information I should know about Rozgra?

• Rozgra suspension may cause drowsiness, dizziness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Take Rozgra suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Rozgra suspension 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.
• Patients with heart problems who take Rozgra suspension may be at increased risk of heart-related side effects, including a heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
• Rozgra suspension may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• Rozgra suspension may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Rozgra suspension. This may lead to decreased vision or a permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Rozgra suspension. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
• Tell your doctor or dentist that you take Rozgra suspension before you receive any medical or dental care, emergency care, or surgery.
• Do not use medicines or treatments for ED while you are taking Rozgra suspension without first checking with your doctor.
• Use Rozgra suspension with caution in the ELDERLY; they may be more sensitive to its effects.
• Rozgra suspension is not approved for use in children. An increase in death has been seen in children as the dose of Rozgra suspension gets higher. However, your child's doctor may decide the benefits of taking Rozgra suspension may outweigh the risks. Talk with the doctor if you have questions about giving Rozgra suspension to your child.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Rozgra suspension while you are pregnant. It is not known if Rozgra suspension is found in breast milk. If you are or will be breast-feeding while you take Rozgra suspension, check with your doctor. Discuss any possible risks to your baby.

Rozgra contraindications

Do not take Rozgra if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Rozgra with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Rozgra.

Do not take Rozgra more than once a day. Allow 24 hours to pass between doses. Do not take Rozgra while also taking Rozgra, unless your doctor tells you to.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Rozgra can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Rozgra, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether Rozgra is the actual cause of vision loss.

Stop using Rozgra and get emergency medical help if you have sudden vision loss.

References

1. European Chemicals Agency - ECHA. "5-(2-Ethoxy-5-((4-methylpiperazin-1-yl)sulphonyl)phenyl)-1,6-dihydro-1-methyl-3-propyl-7H-pyrazolo[4,3-d]pyrimidin-7-one: 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).
2. HSDB. "SILDENAFIL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NIST. "Sildenafil". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology