Adcirca Side Effects

Generic Name: tadalafil

Please note - some side effects for Adcirca may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Adcirca - for the Consumer

Adcirca

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Adcirca:

Flushing; headache; heartburn; mild pain in the arms, legs, or back; muscle pain; nausea; stomach upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Adcirca:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; memory loss; numbness in arm or leg; one-sided weakness; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; shortness of breath or wheezing; slurred speech; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Adcirca Side Effects - for the Professional

Adcirca

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

• Hypotension [see Warnings and Precautions (5.1)]
• Vision loss [see Warnings and Precautions (5.5)]
• Hearing loss [see Warnings and Precautions (5.6)]
• Priapism [see Warnings and Precautions (5.8)]

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.

Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of Adcirca, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for Adcirca 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with Adcirca 40 mg was 4% compared to 5% in placebo-treated patients.

In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the Adcirca 40 mg group and occurring more frequently than with placebo.

TABLE 1: Treatment-Emergent Adverse Events Reported by ≥9% of Patients in Adcirca and More Frequent than Placebo by 2%

EVENT	Placebo (%) (N=82)	Adcirca 20 mg (%) (N=82)	Adcirca 40 mg (%) (N=79)
Headache	15	32	42
Myalgia	4	9	14
Nasopharyngitis	7	2	13
Flushing	2	6	13
Respiratory Tract Infection (Upper and Lower)	6	7	13
Pain in Extremity	2	5	11
Nausea	6	10	11
Back Pain	6	12	10
Dyspepsia	2	13	10
Nasal Congestion (Including sinus congestion)	1	0	9

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.

Cardiovascular and cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. 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 tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].

Body as a whole — Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis

Nervous — Migraine, seizure and seizure recurrence, and transient global amnesia

Ophthalmologic — Visual field defect, retinal vein occlusion, and retinal artery occlusion

Non–arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.5) and Patient Counseling Information (17)].

Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.6) and Patient Counseling Information (17)].

Urogenital — Priapism [see Warnings and Precautions (5.8)].

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, and tachycardia.

Dermatologic

Dermatologic side effects have included pruritus, rash, and sweating.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, loose stools, nausea, upper abdominal pain, and vomiting.

General

General side effects have included asthenia, face edema, facial flushing, fatigue, and pain in a limb.

Genitourinary

Genitourinary side effects have included increased erection and spontaneous penile erection.

Hepatic

Hepatic side effects have included abnormal liver function tests such as an increased GGTP.

Musculoskeletal

Musculoskeletal side effects have included back pain or myalgia, arthralgia, and neck pain.

Respiratory

Respiratory side effects have included nasal congestion, dyspnea, epistaxis, pharyngitis, nasopharyngitis, upper respiratory tract infection, and bronchitis.

Nervous system

Nervous system side effects have included headache, dizziness, hypesthesia, insomnia, paresthesia, somnolence, migraine and vertigo. Postmarketing experience has included seizure and seizure recurrence and transient global amnesia.

Ocular

Ocular side effects have included blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, increased lacrimation, and swelling of the eyelids.

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil.

Other

Other side effects have included cases of sudden decrease or loss of hearing reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

Hypersensitivity

Hypersensitivity side effects have included Stevens-Johnson syndrome and exfoliative dermatitis.

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