PAXIL SIDE EFFECTS
- Generic Name: paroxetine hydrochloride
- Brand Name: Paxil
- Drug Class: Antidepressants, SSRIs
SIDE EFFECTS
The following adverse reactions are included in more detail in other sections of the prescribing information:
- Hypersensitivity reactions to paroxetine
- Suicidal Thoughts and Behaviors
- Serotonin Syndrome
- Embryofetal and Neonatal Toxicity
- Increased Risk of Bleeding
- Activation of Mania/Hypomania
- Discontinuation Syndrome
- Seizures
- Angle-closure Glaucoma
- Hyponatremia
- Bone Fracture
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.
The safety data for PAXIL are from:
- 6-week clinical trials in MDD patients who received PAXIL 20 mg to 50 mg once daily
- 12-week clinical trials in OCD patients who received PAXIL 20 mg to 60 mg once daily
- 10- to 12-week clinical trials in PD patients who received PAXIL 10 mg to 60 mg once daily
- 12-week clinical trials in SAD patients who received PAXIL 20 mg to 50 mg once daily
- 8-week clinical trials in GAD patients who received PAXIL 10 mg to 50 mg once daily
- 12-week clinical trials in PTSD patients who received PAXIL 20 mg to 50 mg once daily
Adverse Reactions Leading To Discontinuation
Twenty percent (1,199/6,145) of patients treated with PAXIL in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with PAXIL in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction. The most common adverse reactions (≥1%) associated with discontinuation (i.e., those adverse reactions associated with dropout at a rate approximately twice or greater for PAXIL compared to placebo) are presented in Table 1:
Table 1: Adverse Reactions Reported as Leading to Discontinuation (≥1% of PAXIL-Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials
| MDD | OCD | PD | SAD | GAD | PTSD | |||||||
| PAXIL % |
Placebo % |
PAXIL % |
Placebo % |
PAXIL % |
Placebo % |
PAXIL % |
Placebo % |
PAXIL % |
Placebo % |
PAXIL % |
Placebo % |
|
| CNS | ||||||||||||
| Somnolence | 2.3 | 0.7 | – | 1.9 | 0.3 | 3.4 | 0.3 | 2.0 | 0.2 | 2.8 | 0.6 | |
| Insomnia | – | – | 1.7 | 0 | 1.3 | 0.3 | 3.1 | 0 | – | – | ||
| Agitation | 1.1 | 0.5 | – | – | – | |||||||
| Tremor | 1.1 | 0.3 | – | 1.7 | 0 | 1.0 | 0.2 | |||||
| Anxiety | – | – | – | 1.1 | 0 | – | – | |||||
| Dizziness | – | – | 1.5 | 0 | 1.9 | 0 | 1.0 | 0.2 | – | – | ||
| Gastrointestinal | ||||||||||||
| Constipation | – | 1.1 | 0 | |||||||||
| Nausea | 3.2 | 1.1 | 1.9 | 0 | 3.2 | 1.2 | 4.0 | 0.3 | 2.0 | 0.2 | 2.2 | 0.6 |
| Diarrhea | 1.0 | 0.3 | – | |||||||||
| Dry mouth | 1.0 | 0.3 | – | – | – | |||||||
| Vomiting | 1.0 | 0.3 | – | 1.0 | 0 | – | – | |||||
| Flatulence | 1.0 | 0.3 | ||||||||||
| Other | ||||||||||||
| Asthenia | 1.6 | 0.4 | 1.9 | 0.4 | 2.5 | 0.6 | 1.8 | 0.2 | 1.6 | 0.2 | ||
| Abnormal Ejaculationa | 1.6 | 0 | 2.1 | 0 | 4.9 | 0.6 | 2.5 | 0.5 | – | – | ||
| Sweating | 1.0 | 0.3 | – | 1.1 | 0 | 1.1 | 0.2 | – | – | |||
| Impotencea | – | 1.5 | 0 | – | – | |||||||
| Libido Decreased | 1.0 | 0 | – | – | ||||||||
| Where numbers are not provided the incidence of the adverse reactions in patients treated with PAXIL was not >1% or was not greater than or equal to 2 times the incidence of placebo. a. Incidence corrected for gender. |
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Most Common Adverse Reactions
The most commonly observed adverse reactions associated with the use of PAXIL (incidence of 5% or greater and at least twice that for placebo) were:
MDD
Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.
OCD
Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.
PD
Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.
SAD
Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.
GAD
Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.
PTSD
Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.
Adverse Reactions In Patients With MDD
Table 2 presents the adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of PAXIL-treated patients with MDD.
Table 2: Adverse Reactions (≥1% of PAXIL-Treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD
| Body System/Adverse Reaction | PAXIL (n = 421) % |
Placebo (n = 421) % |
| Body as a Whole | ||
| Headache | 18 | 17 |
| Asthenia | 15 | 6 |
| Cardiovascular | ||
| Palpitation | 3 | 1 |
| Vasodilation | 3 | 1 |
| Dermatologic | ||
| Sweating | 11 | 2 |
| Rash | 2 | 1 |
| Gastrointestinal | ||
| Nausea | 26 | 9 |
| Dry Mouth | 18 | 12 |
| Constipation | 14 | 9 |
| Diarrhea | 12 | 8 |
| Decreased Appetite | 6 | 2 |
| Flatulence | 4 | 2 |
| Oropharynx Disordera | 2 | 0 |
| Dyspepsia | 2 | 1 |
| Musculoskeletal | ||
| Myopathy | 2 | 1 |
| Myalgia | 2 | 1 |
| Myasthenia | 1 | 0 |
| Nervous System | ||
| Somnolence | 23 | 9 |
| Dizziness | 13 | 6 |
| Insomnia | 13 | 6 |
| Tremor | 8 | 2 |
| Nervousness | 5 | 3 |
| Anxiety | 5 | 3 |
| Paresthesia | 4 | 2 |
| Libido Decreased | 3 | 0 |
| Drugged Feeling | 2 | 1 |
| Confusion | 1 | 0 |
| Respiration | ||
| Yawn | 4 | 0 |
| Special Senses | ||
| Blurred Vision | 4 | 1 |
| Taste Perversion | 2 | 0 |
| Urogenital System | ||
| Ejaculatory Disturbanceb,c | 13 | 0 |
| Other Male Genital Disordersb,d | 10 | 0 |
| Urinary Frequency | 3 | 1 |
| Urination Disordere | 3 | 0 |
| Female Genital Disordersb,f | 2 | 0 |
| a. Includes mostly “lump in throat” and “tightness in throat.” b. Percentage corrected for gender. c. Mostly “ejaculatory delay.” d. Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.” e. Includes mostly “difficulty with micturition” and “urinary hesitancy.” f. Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.” |
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Adverse Reactions In Patients With OCD, PD, And SAD
Table 3 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with OCD, PD, and SAD.
Table 3. Adverse Reactions (≥2% of PAXIL-Treated Patients and Greater than Placebo) in 10 to 12-Week Clinical Trials for OCD, PD, and SAD
| Body System/ Preferred Term | Obsessive Compulsive Disorder | Panic Disorder | Social Anxiety Disorder | |||
| PAXIL (n = 542) % |
Placebo (n = 265) % |
PAXIL (n = 469) % |
Placebo (n = 324) % |
PAXIL (n = 425) % |
Placebo (n = 339) % |
|
| Body as a Whole | ||||||
| Asthenia | 22 | 14 | 14 | 5 | 22 | 14 |
| Abdominal Pain | – | – | 4 | 3 | – | – |
| Chest Pain | 3 | 2 | – | – | – | – |
| Back Pain | – | – | 3 | 2 | – | – |
| Chills | 2 | 1 | 2 | 1 | – | – |
| Trauma | – | – | – | – | 3 | 1 |
| Cardiovascular | ||||||
| Vasodilation | 4 | 1 | – | – | – | – |
| Palpitation | 2 | 0 | – | – | – | – |
| Dermatologic | ||||||
| Sweating | 9 | 3 | 14 | 6 | 9 | 2 |
| Rash | 3 | 2 | – | – | – | – |
| Gastrointestinal | ||||||
| Nausea | 23 | 10 | 23 | 17 | 25 | 7 |
| Dry Mouth | 18 | 9 | 18 | 11 | 9 | 3 |
| Constipation | 16 | 6 | 8 | 5 | 5 | 2 |
| Diarrhea | 10 | 10 | 12 | 7 | 9 | 6 |
| Decreased Appetite | 9 | 3 | 7 | 3 | 8 | 2 |
| Dyspepsia | – | – | – | – | 4 | 2 |
| Flatulence | – | – | – | – | 4 | 2 |
| Increased Appetite | 4 | 3 | 2 | 1 | – | – |
| Vomiting | – | – | – | – | 2 | 1 |
| Musculoskeletal | ||||||
| Myalgia | – | – | – | – | 4 | 3 |
| Nervous System | ||||||
| Insomnia | 24 | 13 | 18 | 10 | 21 | 16 |
| Somnolence | 24 | 7 | 19 | 11 | 22 | 5 |
| Dizziness | 12 | 6 | 14 | 10 | 11 | 7 |
| Tremor | 11 | 1 | 9 | 1 | 9 | 1 |
| Nervousness | 9 | 8 | – | – | 8 | 7 |
| Libido Decreased | 7 | 4 | 9 | 1 | 12 | 1 |
| Agitation | – | – | 5 | 4 | 3 | 1 |
| Anxiety | – | – | 5 | 4 | 5 | 4 |
| Abnormal Dreams | 4 | 1 | – | – | – | – |
| Concentration Impaired | 3 | 2 | – | – | 4 | 1 |
| Depersonalization | 3 | 0 | – | – | – | – |
| Myoclonus | 3 | 0 | 3 | 2 | 2 | 1 |
| Amnesia | 2 | 1 | – | – | – | – |
| Respiratory System | ||||||
| Rhinitis | – | – | 3 | 0 | – | – |
| Pharyngitis | – | – | – | – | 4 | 2 |
| Yawn | – | – | – | – | 5 | 1 |
| Special Senses | ||||||
| Abnormal Vision | 4 | 2 | – | – | 4 | 1 |
| Taste Perversion | 2 | 0 | – | – | – | – |
| Urogenital System | ||||||
| Abnormal Ejaculationa | 23 | 1 | 21 | 1 | 28 | 1 |
| Dysmenorrhea | – | – | – | – | 5 | 4 |
| Female Genital Disordera | 3 | 0 | 9 | 1 | 9 | 1 |
| Impotencea Urinary | 8 | 1 | 5 | 0 | 5 | 1 |
| Frequency | 3 | 1 | 2 | 0 | – | – |
| Urination Impaired | 3 | 0 | – | – | – | – |
| Urinary Tract Infection | 2 | 1 | 2 | 1 | – | – |
| a. Percentage corrected for gender. | ||||||
Adverse Reactions In Patients With GAD And PTSD
Table 4 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with GAD and PTSD.
Table 4. Adverse Reactions (≥2% of PAXIL-Treated Patients and Greater than Placebo) in 8- to 12-Week Clinical Trials for GAD and PTSDa
| Body System/Preferred Term | Generalized Anxiety Disorder | Posttraumatic Stress Disorder | ||
| PAXIL (n = 735) % |
Placebo (n = 529) % |
PAXIL (n = 676) % |
Placebo (n = 504) % |
|
| Body as a Whole | ||||
| Asthenia | 14 | 6 | 12 | 4 |
| Headache | 17 | 14 | – | – |
| Infection | 6 | 3 | 5 | 4 |
| Abdominal Pain | 4 | 3 | ||
| Trauma | 6 | 5 | ||
| Cardiovascular | ||||
| Vasodilation | 3 | 1 | 2 | 1 |
| Dermatologic | ||||
| Sweating | 6 | 2 | 5 | 1 |
| Gastrointestinal | ||||
| Nausea | 20 | 5 | 19 | 8 |
| Dry Mouth | 11 | 5 | 10 | 5 |
| Constipation | 10 | 2 | 5 | 3 |
| Diarrhea | 9 | 7 | 11 | 5 |
| Decreased Appetite | 5 | 1 | 6 | 3 |
| Vomiting | 3 | 2 | 3 | 2 |
| Dyspepsia | – | – | 5 | 3 |
| Nervous System | 3 | |||
| Insomnia | 11 | 8 | 12 | 11 |
| Somnolence | 15 | 5 | 16 | 5 |
| Dizziness | 6 | 5 | 6 | 5 |
| Tremor | 5 | 1 | 4 | 1 |
| Nervousness | 4 | 3 | – | – |
| Libido Decreased | 9 | 2 | 5 | 2 |
| Abnormal Dreams | 3 | |||
| Respiratory System | ||||
| Respiratory Disorder | 7 | 5 | – | – |
| Sinusitis | 4 | 3 | – | – |
| Yawn | 4 | – | 2 | <1 |
| Special Senses | ||||
| Abnormal Vision | 2 | 1 | 3 | 1 |
| Urogenital System | ||||
| Abnormal Ejaculationa | 25 | 2 | 13 | 2 |
| Female Genital Disordera | 4 | 1 | 5 | 1 |
| Impotencea | 4 | 3 | 9 | 1 |
| a. Percentage corrected for gender. | ||||
Dose Dependent Adverse Reactions
MDD
A comparison of adverse reaction rates in a fixed-dose study comparing PAXIL10 mg, 20 mg, 30 mg, and 40 mg once daily with placebo in the treatment of MDD revealed dose dependent adverse reactions, as shown in Table 4:
Table 5. Adverse Reactions (≥5% of PAXIL-Treated Patients and ≥ Twice the Rate of Placebo) (in a Dose-Comparison Trial in the Treatment of MDD
| Body System/Preferred Term | Placebo n = 51 % |
PAXIL | |||
| 10 mg n = 102 % |
20 mg n = 104 % |
30 mg n = 101 % |
40 mg n = 102 % |
||
| Body as a Whole | |||||
| Asthenia | 0.0 | 2.9 | 10.6 | 13.9 | 12.7 |
| Dermatology | |||||
| Sweating | 2.0 | 1.0 | 6.7 | 8.9 | 11.8 |
| Gastrointestinal | |||||
| Constipation | 5.9 | 4.9 | 7.7 | 9.9 | 12.7 |
| Decreased Appetite | 2.0 | 2.0 | 5.8 | 4.0 | 4.9 |
| Diarrhea | 7.8 | 9.8 | 19.2 | 7.9 | 14.7 |
| Dry Mouth | 2.0 | 10.8 | 18.3 | 15.8 | 20.6 |
| Nausea | 13.7 | 14.7 | 26.9 | 34.7 | 36.3 |
| Nervous System | |||||
| Anxiety | 0.0 | 2.0 | 5.8 | 5.9 | 5.9 |
| Dizziness | 3.9 | 6.9 | 6.7 | 8.9 | 12.7 |
| Nervousness | 0.0 | 5.9 | 5.8 | 4.0 | 2.9 |
| Paresthesia | 0.0 | 2.9 | 1.0 | 5.0 | 5.9 |
| Somnolence | 7.8 | 12.7 | 18.3 | 20.8 | 21.6 |
| Tremor | 0.0 | 0.0 | 7.7 | 7.9 | 14.7 |
| Special Senses | |||||
| Blurred Vision | 2.0 | 2.9 | 2.9 | 2.0 | 7.8 |
| Urogenital System | |||||
| Abnormal Ejaculation | 0.0 | 5.8 | 6.5 | 10.6 | 13.0 |
| Impotence | 0.0 | 1.9 | 4.3 | 6.4 | 1.9 |
| Male Genital Disorders | 0.0 | 3.8 | 8.7 | 6.4 | 3.7 |
OCD
In a fixed-dose study comparing placebo and PAXIL 20 mg, 40 mg, and 60 mg in the treatment of OCD, there was no clear relationship between adverse reactions and the dose of PAXIL to which patients were assigned.
PD
In a fixed-dose study comparing placebo and PAXIL 10 mg, 20 mg, and 40 mg in the treatment of PD, the following adverse reactions were shown to be dose-dependent: asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation.
SAD
In a fixed-dose study comparing placebo and PAXIL 20 mg, 40 mg and 60 mg in the treatment of SAD, for most of the adverse reactions, there was no clear relationship between adverse reactions and the dose of PAXIL to which patients were assigned.
GAD
In a fixed-dose study comparing placebo and PAXIL 20 mg and 40 mg in the treatment of GAD, the following adverse reactions were shown to be dose-dependent: asthenia, constipation, and abnormal ejaculation.
PTSD
In a fixed-dose study comparing placebo and PAXIL 20 mg and 40 mg in the treatment of PTSD, the following adverse reactions were shown to be dose-dependent: impotence and abnormal ejaculation.
Male And Female Sexual Dysfunction
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.
The percentage of patients reporting symptoms of sexual dysfunction in males and females with MDD, OCD, PD, SAD, GAD, and PTSD are displayed in Table 6.
Table 6. Adverse Reactions Related to Sexual Dysfunction in Patients Treated with PAXIL in Clinical Trials of MDD, OCD, PD, SAD, GAD, and PTSD
| PAXIL | Placebo | |
| n (males) | 1446 % |
1042 % |
| Decreased Libido | 6 to15 | 0 to 5 |
| Ejaculatory Disturbance | 13 to 28 | 0 to 2 |
| Impotence | 2 to 9 | 0 to 3 |
| n (females) | 1822 % |
1340 % |
| Decreased Libido | 0 to 9 | 0 to 2 |
| Orgasmic Disturbance | 2 to 9 | 0 to 1 |
PAXIL treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.
Hallucinations
In pooled clinical trials of PAXIL, hallucinations were observed in 0.2% of PAXIL-treated patients compared to 0.1% of patients receiving placebo.
Less Common Adverse Reactions
The following adverse reactions occurred during the clinical studies of PAXIL and are not included elsewhere in the labeling.
Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients.
Body as a Whole
Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.
Cardiovascular System
Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.
Digestive System
Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, abnormal liver function tests, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.
Endocrine System
Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.
Hemic and Lymphatic Systems
Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.
Metabolic and Nutritional
Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.
Musculoskeletal System
Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.
Nervous System
Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.
Respiratory System
Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.
Skin and Appendages
Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.
Special Senses
Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.
Urogenital System
Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.
Postmarketing Experience
The following reactions have been identified during post approval use of PAXIL. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, syndrome of inappropriate ADH secretion, prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, oculogyric crisis which has been associated with concomitant use of pimozide; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of severe hypotension when PAXIL was added to chronic metoprolol treatment.
SRC: NLM .